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Reporting Drug Diversion: How to Report (and Why it Matters)

Do you suspect a colleague, physician, pharmacist or nurse is diverting drugs? If so, you’re certainly not alone – drug diversion impacts an estimated 10 to 15 percent of all healthcare workers, including doctors, nurses, medical technicians, home health aides, pharmacists and support staff.

It also affects patients and their families in life-altering ways. Hundreds of patients suffer through unnecessary pain or become infected after an addicted healthcare worker used syringes intended for patients.

For these reasons, reporting suspected drug diversion is critical to stopping it. With that in mind, here are the steps you can take to report suspected drug diversion:

First: Report the incident to the healthcare worker’s supervisor or employer.

Tell someone in charge, such as a clinical supervisor, department head, or, when possible, the healthcare facility’s drug-diversion team. Be ready to describe the incident(s), behaviors and/or evidence that suggest or support the implication that that a healthcare worker is diverting drugs. Sometimes this action will be enough to encourage the individual to seek help. That supervisor or employer is responsible for investigating the incident. If diversion is confirmed, they are responsible for reporting the diversion to the appropriate law enforcement and regulatory agencies, as shown below.

After reporting the incident to the healthcare worker’s supervisor or employer:

Report the incident to HealthCareDiversion.org . This ensures the incident is added to our national database of suspected drug diversion incidents. You can submit the incident anomalously if you would like. And you can be confident that we will only publish identifiable information about the incident after it has been fully investigated and adjudicated by the appropriate authorities.

If the healthcare worker’s supervisor or employer do not investigate your report , and you still suspect diversion has occurred: Report the suspected diversion to the appropriate law enforcement and regulatory agencies, as shown below.

Suspected Drug Diversion Should Be Reported to the Following Organizations:

If Controlled Substances are missing: Send the Drug Enforcement Administration (DEA) a completed DEA-106 Form, Report of Theft or Loss of Controlled Substances within 24 hours that the missing drugs were discovered.

If the person suspected of diverting is a nurse, pharmacist, physician, or other licensed healthcare professional: Report the healthcare worker to their professional licensure board within your state, such as the state Board of Nursing, Board of Pharmacy, or Medical Board. For example, if reporting a nurse within the state of Georgia, call/contact the Georgia Board of Nursing.

If drug tampering has occurred: Report the suspected diversion incident to the Criminal Investigations Unit at the Food and Drug Administration (FDA). As an example of tampering: the person suspected of diverting the drug replaced the medication with another substance, like removing liquid narcotic from a vial and replacing it with water.

If you suspect drugs have been stolen: Report the incident to local law enforcement, such as the police department residing in the healthcare facility’s town or jurisdiction. They will have information or resources to take the next steps in investigating the suspected diversion.

If patients might have been infected , report the incident of suspected diversion to your state Public Health Authority .

If the person who was suspected of diverting is subsequently convicted in a criminal case, or disciplined by their state licensure board : submit this fact to HealthCareDiversion.org, so that we can update the incident to reflect this event, and add this incident to our national database as part of our efforts to prevent drug diversion in the future.

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DEA finalizes rule on reporting theft and significant loss of controlled substances

NCPA June 30, 2023

The DEA recently published a final rule , effective July 24, 2023, which amends the regulations regarding DEA Form 106, used by registrants to formally report thefts or significant losses of controlled substances. The final rule requires that all DEA Form 106s be submitted electronically. DEA will allow registrants 45 days from discovery of the theft or significant loss to submit the form, up from the agency’s original proposal of 15 days. (In comments to the proposed rule back in September 2020, NCPA requested a 60-day timeframe, and alternately supported the proposed 15-day timeframe if that was implemented after the COVID-19 PHE ended.) Notably, the final rule does not change the requirement that registrants preliminarily notify their area DEA Field Division Office of the theft or significant loss of any controlled substances in writing within one business day of discovering such loss or theft. Paper copies of DEA Form 106 will no longer be accepted once the final rule becomes effective.

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Dea theft-reporting requirements, partial refills for c-ii controlled substances, transfer of electronc prescriptions for schedules ii–v controlled substances between pharmacies for initial filling, dea extends covid-19 controlled substances telemedicine rules for 6 months while considering comments from the public.

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DEA Fine-Tunes the Theft and Significant Loss Reporting Two-Step

Like the celebrated Texas dance of the same name, reporting controlled substance thefts and significant losses to the Drug Enforcement Administration (“DEA”) requires just that: two steps.  For the first time in eighteen years, DEA has revised its controlled substance theft and significant loss reporting regulations.  Since 1995, at least 28 registrants, primarily hospitals and pharmacies, have paid significant civil penalties ranging from $10,000 to $5,000,000 to settle allegations that they wholly or in part failed to report, or failed to report in a timely manner, controlled substance thefts or significant losses to DEA.  We thought it appropriate to take this opportunity to not only explain DEA’s revised regulations but also how registrants must now report controlled substance thefts and significant losses.

Step 2: DEA-106 Submission

DEA just published a final rule amending its theft and loss reporting regulations to require registrants to submit a “Report of Theft or Loss of Controlled Substances,” DEA Form 106 (“DEA-106”), electronically to the agency within 45 days of discovery of a theft or significant loss.  Reporting Theft or Significant Loss of Controlled Substances, 88 Fed. Reg. 40707, 40708 (June 22, 2023) (to be codified at 21 C.F.R. §§ 1301.74(c) and .76(b)). Attached here .

The rule now requires registrants to first report a theft or significant loss in writing within one business day of discovery (step 1), followed literally by a DEA-106 filed through the agency’s secure network application “within 45 calendar days” (for non-practitioners) and “within 45 days” (for practitioners) after discovery (step 2).  Id . at 40712.  DEA will no longer accept hardcopy DEA-106s as of July 24, 2023.  Id . at 40708.

DEA’s notice of proposed rulemaking would have required registrants to electronically file a DEA-106 within 15 calendar days after discovery, the original intent to align the shorter DEA-106 submission with the time required for submission of a “Report of Theft or Loss of Listed Chemicals,” DEA Form 107, for listed chemicals.  Id .  DEA expanded the proposed rule to allow 45 days, reasoning “that adequate time is needed in order to complete an accurate and thorough investigation” to submit a DEA-106.  Id . at 40709.  The 45-day timeframe within which to complete the second step allows registrants time to adequately investigate and make a final determination about the incident.  Id .  DEA justified requiring electronic submission of DEA-106s rather than a paper copy because it “will allow all report submissions to be received more quickly and stored in a central database, as well as allow for analysis.”  Id . at 40710.

Step 1: Initial Notification

The final rule does not revise the requirement that registrants must initially notify the DEA field division office in their area in writing within one business day of discovery of a theft or significant loss.  21 C.F.R. §§ 1301.74(c) and .76(b).  Notification by email or facsimile work; a telephone call does not.  Written notification eliminates misunderstanding that can arise with oral communication.  It documents what information was provided, when, and to whom.  Registrants should provide as much information about the incident as possible, including controlled substance quantity and the circumstances if known.  Reporting within one day of discovery allows the agency to know promptly about a theft or significant loss and to investigate immediately or undertake other appropriate actions.  88 Fed. Reg. 40707, 40709.

Registrants must report all controlled substance thefts but only those losses that are “significant.”  The agency does not clarify what constitutes a “theft,” an intentional taking or diversion, while non-theft losses can include miscounting, dispensing an incorrect quantity, or misplacing or accidentally disposing of controlled substances.  In addition, registrants should also report thefts to local law enforcement.

Significant Loss

While DEA regulations require registrants to report all thefts, they must report only controlled substance losses that are “significant.”  21 C.F.R. §§ 1301.74(c) and .76(b).  Registrants have long wrestled with whether a particular loss they have experienced is significant and therefore reportable.  Over the years industry has requested DEA to define what constitutes a “significant loss.”  As with its 2005 revision of the regulations, the agency has again punted on defining “significant loss,” reasoning that what constitutes a significant loss for a manufacturer experiencing continuous losses in the manufacturing process may not be deemed significant by that registrant (but would need to be recorded in batch records).  88 Fed. Reg. 40707, 40709.  For non-manufacturer registrants, the loss of small quantities over time “may indicate a significant aggregate significant loss that must be reported to DEA, even though the individual quantity of each occurrence is not significant.”  Id .  DEA concluded once again that registrants are in the best position to determine whether their loss is significant, requiring reporting.

While not defining what constitutes a significant loss, DEA has again provided a list of factors that registrants should consider in determining whether a loss is significant.  Factors include:

• The actual quantity of controlled substances lost in relation to the type of business;
• The specific controlled substances lost (schedule IIs as opposed to schedule IIIs, IVs and Vs);
• Whether the loss can be associated with access by specific individuals or attributed to unique activities that may take place involving the controlled substances;
• A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses, and, if known;
• Whether the controlled substances are likely candidates for diversion; and
• Local trends and other indicators of diversion potential of the missing controlled substances. 21 C.F.R. §§ 1301.74(c) and .76(b).

Because DEA has abdicated defining whether a loss is significant, the agency should only seek enforcement for failure to report a significant loss in the most egregious cases.

Registrants must report a theft or significant loss in writing within one business day of discovery, followed by a DEA-106 filed electronically within 45 days after discovery.  In 2005, DEA acknowledged that discovery can occur incrementally.  Reports by Registrants of Theft or Significant Loss of Controlled Substances , 79 Fed. Reg. 47094, 47095 (Aug. 12, 2005).  The agency has again declined to define discovery in the current final rule, but plans “on addressing the definition of Discovery in a future rulemaking.”  88 Fed. Reg. 40707, 40709.

DEA Field Division Office

The regulations require registrants to notify the DEA field division office in their area of thefts and significant losses.  Field division offices are the largest offices within a DEA field division where diversion program managers, diversion investigators, program analysts, and registration assistants are assigned, while resident and district offices are smaller offices, only some of which may be staffed by diversion investigators.  Strict adherence to the regulation requires reporting to the larger field division office despite geographic proximity or a relationship with a particular diversion group or investigator.

In-Transit Losses

Suppliers must report all in-transit controlled substance losses, not just those that are thefts or significant.  The agency also does not define “in-transit,” but uses the term in connection with use of a common or contract carrier.  21 C.F.R. § 1301.74(c).  So, suppliers must report any controlled substance lost while en route via common or contract carrier.  Purchasers must report any loss after they have signed for and taken custody of controlled substances.  DEA, Pharmacist’s Manual: An Informational Outline of the Controlled Substances Act (Rev. 2022), at 63.

Breaks and Spills

Breaks, spills, and other witnessed controlled substance losses do not require reporting to DEA.  DEA has reasoned that they are not actually lost “because they can be accounted for.”  Reports by Registrants by Registrants of Theft or Significant Loss of Controlled Substances , 70 Fed. Reg. 40576, 40578 (July 8, 2003).

Miscounts and Inventory Adjustments

Neither controlled substance miscounts nor inventory adjustments involving clerical errors should be reported.

ARCOS Reporting

Thefts and losses must be reported to DEA’s Automation of Reports and Consolidated Orders System (“ARCOS”).  Registrants should report thefts via ARCOS as “thefts” using the appropriate transaction code and report losses as “losses.”  Reporting to ARCOS is in addition to initial notification and electronic submission of a DEA-106.

A one and a two…

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Reporting of theft or significant loss of controlled substances.

A Proposed Rule by the Drug Enforcement Administration on 07/29/2020

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Drug Enforcement Administration, Department of Justice.

Notice of proposed rulemaking.

This proposed rule would amend Drug Enforcement Administration (DEA) regulations regarding DEA Form 106, used by DEA registrants to report thefts or significant losses of controlled substances, to clarify that all such forms must be submitted electronically. In addition, the proposed rule would add new requirements for the form to be submitted accurately and within a 15-day time period. This proposed rule will Start Printed Page 45548 not change the requirement that registrants notify the DEA Field Division Office in their area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft.

Comments must be submitted electronically or postmarked on or before September 28, 2020. Commenters should be aware that the electronic Federal Docket Management System will not accept any comments after 11:59 p.m. Eastern Time on the last day of the comment period.

All comments concerning collection of information under the Paperwork Reduction Act must be submitted to the Office of Management and Budget (OMB) on or before September 28, 2020.

To ensure proper handling of comments, please reference “Docket No. DEA-574” on all electronic and written correspondence, including any attachments.

• Electronic comments: The Drug Enforcement Administration encourages that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission, you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on Regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment.
• Paper comments: Paper comments that duplicate electronic submissions are not necessary. Should you wish to mail a paper comment, in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
• Paperwork Reduction Act Comments: All comments concerning collections of information under the Paperwork Reduction Act must be submitted to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for DOJ, 725 17th Street NW, Washington, DC 20503. Please state that your comment refers to RIN 1117-AB57/Docket No. DEA-547.

Scott A. Brinks, Regulatory Drafting and Policy Support Section (DPW), Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 362-3261.

Please note that all comments received in response to this docket are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at http://www.regulations.gov . Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment.

Comments containing personal identifying information or confidential business information identified as directed above will be made publicly available in redacted form. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.

An electronic copy of this proposed rule is available at http://www.regulations.gov for easy reference.

The Controlled Substances Act (CSA) authorizes the Administrator of DEA (by delegation from the Attorney General) to promulgate rules and regulations relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances; maintenance and submission of records and reports; and for the efficient execution of his statutory functions. 21 U.S.C. 821 , 827 , 871(b) . Currently, 21 CFR 1301.74(c) requires a non-practitioner registrant to notify DEA's Field Division Office in his or her area, in writing, of any theft or significant loss of any controlled substances within one business day upon discovery of such theft or loss. The provision stipulates this same notification requirement and one-day time period regarding in-transit losses of controlled substances for suppliers, importers, and exporters with certain exceptions. In addition to the requirement to notify DEA within one business day of the discovery of a theft or loss, this provision requires a non-practitioner registrant to complete and submit to the same field division office a DEA Form 106 regarding the theft or loss. This provision is silent as to the actual submission method of the DEA Form 106 ( e.g., mail, hand delivery, electronic) and the time period in which these reports are due. This proposed rule will not change the requirement that registrants notify the Field Division Office of the Administration in their area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft.

Similarly, 21 CFR 1301.76(b) currently requires practitioner registrants to notify DEA's Field Division Office in his area, in writing, of the theft or significant loss of any controlled substances within one business day upon discovery of the theft or loss; and to complete and submit DEA Form 106 to the same Field Division Office. Again, this provision is silent as to the actual submission method of DEA Form 106 and the due date for this report.

This proposed rule will not change the requirement under 21 CFR 1301.74(c) and 1301.76(b) , respectively, that non-practitioner and practitioner registrants notify DEA's Field Division Office in their area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft.

Currently, 99.5 percent of all DEA Form 106 submissions are completed electronically via DEA's secure website. The remaining 0.5 percent of form submissions are completed by paper. See Regulatory Analyses section for additional information. Start Printed Page 45549

This proposed rule would set a 15-day calendar period for submitting a complete and accurate DEA Form 106 and clarify the form submission process, requiring all forms be submitted electronically. This would match the submission process for DEA Form 107, a form used by regulated persons  [ 1 ] to report loss or disappearance of listed chemicals. As set forth in 21 CFR 1310.05(b)(1) , a regulated person must file a complete and accurate DEA Form 107 with DEA through the DEA Diversion Control Diversion secure network application (available on the DEA Diversion Control Division website) within 15 calendar days after discovery of the circumstances requiring the report.

These proposed changes would make clear to registrants that all DEA Form 106 submissions must go through the secure online database, and physical copies will no longer be accepted. Through the secure online database, forms will be more easily submitted and organized. [ 2 ]

This proposed rule was developed in accordance with the principles of Executive Orders (E.O.s) 12866, 13563, and 13771. E.O. 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). E.O. 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in E.O. 12866 . E.O. 12866 classifies a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the E.O. DEA has determined that this proposed rule is not a “significant regulatory action” under E.O. 12866 , section 3(f).

DEA has examined the benefits and costs of this proposed rule. Currently, 99.5 percent of all DEA Form 106 reports are reported electronically via DEA's secure website. This proposed rule will impact the remaining 0.5 percent of responses that are reported by paper representing 181 of a total of 37,047 responses. Benefits include costs savings, as discussed in the following paragraphs, and increased simplicity in reporting theft and loss on controlled substances and clarity in the regulations. This proposed rule will add clarity to the submission method by matching the submission process and requirements for “Reports of Loss or Disappearance of Listed Chemicals”—DEA Form 107. Additionally, electronic submissions will allow all report submissions to be received more quickly and stored in a central database, as well as allow for analysis.

There is no new cost associated with this proposed rule. The labor burden to submit DEA Form 106 is estimated to be the same for electronic and paper submissions. However, DEA anticipates there will be cost savings associated with electronic submissions. Some cost savings are described qualitatively and some are quantified. From submissions received in 2018, DEA estimates approximately 181 paper submissions per year. Many of these paper forms contain illegible or erroneous information, requiring DEA to call respondents to correct or clarify the information in the paper form, consuming both DEA's and the respondent's time and resources. Electronic submissions are expected to virtually eliminate the requirement for DEA to call back the respondent for clarifications of form data. As DEA has not tracked the number of call backs or the average duration of calls, DEA does not have a strong basis to quantify the cost savings.

This proposed rule would eliminate the need to print paper forms and transmit by mail or courier service. DEA estimates there will be a cost savings of $0.63, $0.55 for postage plus $0.08 for an envelope, or a total of $114 per year for an estimated 181 responses per year. DEA assumes the cost savings associated with not having to print is negligible.

In summary, DEA estimates the economic impact of this proposed rule is de minimis.

E.O. 13771 was issued on January 30, 2017, and published in the Federal Register on February 3, 2017. [ 3 ] Section 2(a) of E.O. 13771 requires an agency, unless prohibited by law, to identify at least two existing regulations to be repealed when the agency publicly proposes for notice and comment or otherwise promulgates a new regulation. In furtherance of this requirement, Section 2(c) of E.O. 13771 requires that the new incremental costs associated with new regulations, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations. DEA expects this proposed rule will not be considered an E.O. 13771 regulatory action. The estimated economic impact of proposed rule is de minimis.

This proposed regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 Civil Justice Reform to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

This proposed rulemaking does not have federalism implications warranting the application of E.O. 13132 . The proposed rule does not have substantial direct effects on the States, on the relationship between the National Government and the States, or the distribution of power and responsibilities among the various levels of government.

This proposed rule does not have tribal implications warranting the application of E.O. 13175 . This proposed rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Start Printed Page 45550

In accordance with the Regulatory Flexibility Act (RFA), DEA has reviewed the economic impact of this proposed rule on small entities. DEA's economic impact evaluation indicates that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.

The RFA requires agencies to analyze options for regulatory relief of small entities unless it can certify that the rule will not have a significant impact on a substantial number of small entities. For the purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. DEA has analyzed the economic impact of each provision of this proposed rule and estimates that the proposed rule will have minimal economic impact on affected entities, including small entities.

This proposed rule would amend regulations regarding DEA Form 106 to clarify that all submissions of the form must be submitted online. Based on actual submissions in 2018, DEA estimates there are 181 paper submissions per year, submitted by six entities: One distributor, two pharmacies, one researcher, one veterinarian service entity, and one hospital.

DEA estimates the affected entities are in the following North American Industry Classification System (NAICS) industries:

• 424210—Drugs and Druggists' Sundries Merchant Wholesalers
• 446110—Pharmacies and Drug Stores
• 541712—Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
• 541940—Veterinary Services
• 622110—General Medical and Surgical Hospitals

The U.S. Census Bureau's Statistics of U.S. Businesses (SUSB) is an annual series that provides economic data by enterprise size and industry. SUSB data contains the number of firms for various employment or revenue size ranges for each industry. Comparing the size ranges to the U.S. Small Business Administration (SBA) size standards, DEA estimated the number of entities in each affected industry, number of small entities in each affected industry, and number of affected small entities. The table below summarizes the results.

There is no new cost associated with this proposed rule. The labor burden to submit DEA Form 106 is estimated to be the same for electronic and paper submissions. However, DEA anticipates there will be cost savings associated with electronic submissions. Some cost savings are described qualitatively and some are quantified. From submissions received in 2018, DEA estimates the one affected small entity submits one paper submission per year. Many of these paper forms contain illegible or erroneous information, requiring DEA to call respondents to correct or clarify the information in the paper form, consuming DEA's and the respondent's time and resources. Electronic submissions are expected to virtually eliminate the requirement for DEA to call back the respondent for clarifications of form data. As DEA has not tracked the number of call backs or the average duration of calls, DEA does not have a strong basis to quantify the cost savings.

DEA estimates there will be a cost saving associated with eliminating the need to print paper forms and transmit by mail or courier service. The estimated cost savings is $0.63, $0.55 for postage plus $0.08 for an envelope, per paper submission.

In summary, DEA estimates this rule will affect six entities who submit 181 paper DEA Forms 106. Of the affected six entities, one entity (veterinary services entity) is a small entity, submitting one paper form per year. The estimated cost savings for the affected small entity is minimal ($0.63 per year). Therefore, this proposed rule, if promulgated, will not have a significant economic impact on a substantial number of small entities.

On the basis of information contained in the “Regulatory Flexibility Act” section above, DEA has determined and certifies pursuant to the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1501 et seq., that this action would not result in any Federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year * * * * .” Therefore, neither a Small Government Agency Plan nor any other action is required under provisions of UMRA.

Pursuant to the Paperwork Reduction Act of 1995 (PRA) ( 44 U.S.C. 3501-3521 ), DEA has identified the following collection of information related to this proposed rule. This action would modify existing collection 1117-0001 and DEA will be submitting the revision to OMB for approval. A person is not required to respond to a collection of information unless it displays a valid OMB control number. Copies of existing information collections approved by OMB may be obtained at https://www.reginfo.gov/​ . DEA has submitted this collection request to OMB for review and approval. Start Printed Page 45551

Title: Amending Regulations Regarding DEA Form 106

OMB Control Number: 1117-0001

Form Number: DEA-106

DEA is proposing to amend its regulations for reporting thefts or significant losses of controlled substances to implement the requirement of electronic submissions for reporting the thefts or significant losses of controlled substances to clarify that all such reports must be submitted electronically within 15 days of discovery of the circumstances requiring the report. This amendment would clarify the submission process by aligning it with the current requirements of reporting losses of disappearance of listed chemicals on DEA Form 107 and no longer accepting physical copies. Form 107 (OMB Control Number 1117-0024) is also only submitted electronically, within 15 days of discovery of the circumstances requiring the report.

Currently, 99.5 percent of all DEA Form 106 reports are reported electronically via DEA's secure website. This proposed rule will impact the remaining 0.5 percent of responses that are reported by paper. Electronic submissions are expected to virtually eliminate the requirement for DEA to call back the respondent for clarifications of form data. Furthermore, this proposed rule would eliminate the need for respondents to print paper forms and transmit by mail or courier service, resulting in cost savings for the 0.5 percent of responses per year transitioning from paper to electronic forms.

The electronic submission would be filed with DEA through the DEA Diversion Control Diversion secure network application (available on the DEA Diversion Control Division website). The submissions of forms will be more easily submitted and organized through the secure database.

The DEA estimates the following number of respondents and burden associated with this collection of information:

• Number of respondents: 10,693.
• Frequency of response: 3.4646 (calculated).
• Number of responses: 37,047.
• Burden per response: 0.3333 hours.
• Total annual hour burden: 12,349 hours.

Written comments and suggestions from the public and affected entities concerning the proposed revision of this collection of information are encouraged. Under the PRA, DEA is required to provide a notice regarding the proposed collections of information in the Federal Register with the notice of proposed rulemaking and solicit public comment. Pursuant to section 3506(c)(2) of the PRA ( 44 U.S.C. 3506(c)(2) ), DEA is soliciting comment on the following issues related to this information of collection:

• Whether the proposed collection of information is necessary for the proper performance of the functions of DEA, including whether the information will have practical utility.
• The accuracy of DEA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
• Recommendations to enhance the quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the burden of the collection of information on those who are to respond, including through the use of automated collection techniques or other forms of information technology.

Please send written comments to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for DOJ, 725 17th Street NW, Washington, DC 20503. Please state that your comments refer to RIN 1117-AB57/Docket No. DEA-574. All comments must be submitted to OMB on or before September 28, 2020. The final rule will respond to any OMB or public comments on the information collection requirements contained in this proposed rule.

If you need a copy of the proposed information collection instrument(s) with instructions or additional information, please contact the Regulatory Drafting and Policy Support Section (DPW), Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152-2639; Telephone: (571) 362-3261.

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For the reasons set out above, the DEA proposes to amend 21 CFR part 1301 as follows:

1. The authority citation for part 1301 continues to read as follows:

Authority: 21 U.S.C. 821 , 822 , 823 , 824 , 831 , 871(b) , 875 , 877 , 886a , 951 , 952 , 956 , 957 , 958 , 965 unless otherwise noted.

2. In § 1301.74, revise the fifth sentence of paragraph (c) introductory text to read as follows:

(c) * * * The registrant must also file a complete and accurate DEA Form 106 with the Administration through the DEA Diversion Control Division secure network application within 15 calendar days after discovery of the theft or loss. * * *

3. In § 1301.76, revise the second sentence of paragraph (b) introductory text to read as follows:

(b) * * * The registrant must also file a complete and accurate DEA Form 106 with the Administration through the DEA Diversion Control Division secure network application within 15 calendar days after the discovery of theft or loss. * * *

Timothy J. Shea,

Acting Administrator.

1.  The term “regulated person” is defined at 21 U.S.C. 802(38) .

2.   https://www.deadiversion.usdoj.gov/​21cfr_​reports/​theft/​index.html .

3.   82 FR 9339 .

[ FR Doc. 2020-15635 Filed 7-28-20; 8:45 am]

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Regulatory Alert: DEA’s New Controlled Substance Theft or Loss Rule Includes a New Deadline and May Require Changes to Corporate Compliance Systems

On July 24, 2023, a new final rule from the Drug Enforcement Administration (DEA) became effective, with important consequences for companies and individuals registered to manufacture, distribute, or dispense controlled substances. Specifically, DEA will now require that registrants submit DEA’s “Form 106”, which provides information regarding the theft or significant losses of controlled substances, electronically and within 45 calendar days of discovery of the theft or loss . As there previously was no specific deadline to submit Form 106, this update could have significant potential implications for companies at all levels of the controlled substances supply chain and require immediate attention and allocation of resources to ensure compliance.

Pursuant to the relevant provision of the Controlled Substances Act (CSA), 21 U.S.C. § 830(b)(1)(C), all individuals and entities registered to manufacture, distribute, or dispense controlled substances must report “any unusual or excessive loss or disappearance of a listed chemical under the control of the regulated person.” DEA regulations have provided additional guidance on this requirement, previously requiring in 21 C.F.R. § 1301.74(c) that:

The registrant must notify the Field Division Office of the Administration in his or her area, in writing, of any theft or significant loss of any controlled substances within one business day of discovery of the theft or loss. . . . The registrant must also complete, and submit to the Field Division Office in his or her area, DEA Form 106 regarding the theft or loss. Thefts and significant losses must be reported whether or not the controlled substances are subsequently recovered or the responsible parties are identified and action taken against them.

Similarly, 21 C.F.R. § 1301.76(b) previously provided:

The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The registrant shall also complete, and submit to the Field Division Office in his area, DEA Form 106 regarding the loss or theft.

These regulations failed, however, to provide registrants with any guidance as to when they needed to file Form 106 following the theft or loss.

As a result of this ambiguity, DEA issued the new rule revising both Sections 1301.74(c) and 1301.76(b) to now require that registrants file a completed Form 106 “ through the DEA Diversion Control Division secure network application within 45 calendar days after discovery of the theft or loss .” DEA published its initial notice of proposed rulemaking on July 29, 2020 (85 FR 45547), and after a lengthy comment period, which included pushback from industry groups concerning DEA’s initially-proposed 15-day deadline, DEA issued its final rule with the 45-day deadline.

Implications for Registrants: Critical to Complete Form 106 Within 45 Calendar Days

DEA’s clarification of the deadline to file a completed Form 106 within 45 calendar days of discovery of the theft or loss will have significant consequences for DEA registrants, which include manufacturers, distributors, pharmacies, and practitioners that are registered to manufacture, distribute, or dispense controlled substances.

This new 45-day deadline represents a greater opportunity for registrants to investigate the circumstances surrounding the theft or loss, and complete Form 106 accordingly. However, with a strict deadline in place, registrants will need to ensure that they have a compliance system in place that can adequately investigate the theft or loss, complete Form 106, and submit it to the local DEA Field Division Office within 45 calendar days. Failure to submit on time risks significant penalties pursuant to 21 U.S.C. § 842(c), including potential loss of registration to distribute controlled substances, civil fines, and criminal fines. Further, the small minority of registrants that file a Form 106 via paper submissions (DEA has reported that as of 2018, 99.5% of submissions of Form 106 were conducted electronically) will have to revise their compliance schemes to report through DEA’s electronic system.

It must be noted that this rule does not revise 21 CFR § 1310.05(b)(1), which still requires registrants to report “unusual or excessive loss or disappearance of a listed chemical” using DEA Form 107 within 15 calendar days after being aware of the loss. This update also does not change the requirement under 21 C.F.R. § 1301.74(c) that all registrants must notify DEA of the theft or loss within one business day of discovery.

Lingering Questions: Regulatory Vagueness Concerning “Discovery” of Theft and Loss and the Definition of a “Significant Loss”

Despite DEA providing clarity on the method and deadline for filing a Form 106, there remain open questions in the regulations for registrants for when it is necessary to report losses of controlled substances to DEA and what losses are reportable under 21 C.F.R. § 1301.74(c) and 21 C.F.R. § 1301.76(b).

Both of those regulations require registrants to report a “significant loss” of controlled substances to DEA. Although it does not provide a precise definition, 21 C.F.R. §1301.74(c) provides six factors for a registrant to determine a significant loss:

(1) The actual quantity of controlled substances lost in relation to the type of business

(2) The specific controlled substances lost

(3) Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances

(4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known,

(5) Whether the specific controlled substances are likely candidates for diversion

(6) Local trends and other indicators of the diversion potential of the missing controlled substance

In the final rule, DEA acknowledges the ambiguity of these factors, noting that “[t]he distinction between a significant loss and a normal loss is case and circumstance specific, and registrants are best positioned to determine whether a loss rises to the level of a significant loss.” Accordingly, registrants will have to remain vigilant as to whether DEA will consider any losses of controlled substances “significant” under this standard.

The second open issue concerns when the 45-day countdown begins for filing the Form 106 and when the one-day deadline begins for providing notice to DEA of the loss or theft. Pursuant to 21 C.F.R. § 1301.74(c) and 21 C.F.R. § 1301.76(b), the responsibility arises when the registrant “discovers” the loss or theft.

Again, however, the regulations do not provide a clear definition of what constitutes discovery of the loss or theft. In the final rule, DEA recognizes “that there is some confusion on the meaning of ‘discovery’” and stated that “the discovery occurs in incremental stage.” Crucially, the final rule includes that “DEA is planning on addressing the definition of Discovery in a future rulemaking.” Accordingly, registrants may be looking forward to receiving additional guidance for when they need to report losses or thefts of controlled substances.

Foley is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group  with any questions.

Katy E. Koski

Related insights, podcast episode 111: mikle jew, senior counsel, foley pride month program lights the way to becoming a better ally, foley automotive update.

DEA Final Rule: Reporting Theft or Significant Loss of Controlled Substances

• Alyssa Leiva
• June 26, 2023

Summary:  DEA form 106 used to  report thefts or significant losses of controlled substances can only be submitted electronically. Registrants will have 45 days, after discovery of the theft or loss, to complete and submit an accurate DEA Form 106 through the DEA Diversion Control Division secure network application. This final rule does not change the requirement that registrants preliminarily notify the DEA Field Division Office in their area , in writing, of the theft or significant loss of any controlled substances within one business day of discovering such theft or loss. 

What does this mean to you? Visit our information page for all you need to know.

Diversion, Significant Loss, Spills or Theft

Federal Register Notice

Date June 22, 2023

The Final Rule:   Reporting Theft or Significant Loss of Controlled Substances (DEA574), published on June 22, 2023, in the Federal Register under citation 88 FR 40707. 

This rule amends DEA regulations regarding DEA Form 106, used by DEA registrants to report thefts or significant losses of controlled substances, to require the DEA Form 106 be submitted electronically , and clarifies the timeframe registrants have to complete the necessary documentation.

Effective July 24, 2023, registrants will be required to submit all DEA Forms 106 electronically (online) through DEA’s Diversion Control Division secure network application.  After July 24, 2023, DEA will no longer accept paper submissions of the DEA Form 106.  Thus, eliminating all paper submissions of the DEA Form 106 after July 24, 2023.

This Final Rule also requires a timeframe on the submission of the DEA Form 106.  Registrants will have 45 days, after discovery of the theft or loss, to complete and submit an accurate DEA Form 106 through the DEA Diversion Control Division secure network application. 

This final rule does not change the requirement that registrants preliminarily notify the DEA Field Division Office in their area , in writing, of the theft or significant loss of any controlled substances within one business day of discovering such theft or loss. 

For further information, please contact : 

Scott A Brinks, Regulatory Drafting and Policy Support Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 776-3882; Email: [email protected] .

If you are experiencing an emergency, please call 9-1-1.   EH&S Main Line (Office): (310) 825-5689

Report an incident (EH&S Hotline): (310) 825-9797

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DEA Makes Changes in the Process for Reporting Theft or Significant Loss of Controlled Substances

Effective July 22, 2023, the U.S. Drug Enforcement Agency (DEA) will no longer accept paper filing from Registrants when reporting the theft or “significant loss” of Controlled Substances.

On June 22, 2023, the DEA published a Final Rule amending the regulations regarding DEA Form 106, which is required for all Registrants to formally report any theft or significant loss of Controlled Substances to the DEA under the Controlled Substances Act (CSA) [1] .  While the current regulation required the submission of the DEA 106, it was silent as to the mechanism and timing for doing so.  In its Final Rule, the DEA indicated that 99.5% of all DEA 106 submissions were through a secure application on the DEA’s Diversion Control Division’s website, and the remaining .5% were submitted on paper.  The Final Rule eliminates paper filing to ensure that the DEA receives legible and timely submission of the DEA Form 106. With the issuance of its Final Rule, the DEA is mandating that all DEA Form 106 be filed with the Administration electronically.  Further, the Final Rule adds a timeframe for submission—within 45 calendar days of discovery of the theft or loss.  

This reporting is the second step in the current 2-step process; the first step being an initial report within one business day .  Notably, despite comments that the one-day reporting requirement should be abolished—claiming it was arbitrary, confusing and redundant—the DEA disagreed and declined to alter the current two-step reporting requirement.  Thus, under the Final Rule, Registrants must report thefts or losses of Controlled Substances as follows:

• a preliminary report of all thefts and significant losses must be reported to the Registrant’s local DEA Field Office within one (1) business day of discovery;
• a DEA Form 106 must be submitted online within 45 calendar days.

The DEA also rejected comments that the term “significant loss” should be defined, noting that the decision is one that is best made by the Registrant based on the specific case and circumstances.

Regarding other comments on a definition of “discover” to assist in determining when the reporting obligations commence, the DEA indicated that it would address that issue in future rulemaking.

While the Final Rule does not make a significant change in a Registrant’s reporting obligations, it provides welcome clarification on the procedure for submitting a DEA Form 106 and serves as a reminder that Registrants need to be vigilant in their efforts to secure their Controlled Substances through internal processes ( i.e., accurate inventories/record-keeping, auditing and training on drug diversion, systems for timely reporting and follow-up).  Failure to do so can lead to costly penalties and DEA oversight. [2]

Butzel will continue to monitor the DEA reporting process, however if you have questions or would like to discuss the topic, please contact your Butzel health care attorney.

Debra Geroux  248.258.2603 geroux@butzel.com

Mark Lezotte 313.225.7058 lezotte@butzel.com

Robert Schwartz 248.258.2611                                     schwartzrh@butzel.com

[1] 21 C.F.R. 1301.74(c) and 1301.76(b).

[2] By way of example, in November 2021, the University of Texas Southwestern Medical Center entered into a Settlement Agreement with the DOJ to resolve allegations of violations of the CSA, agreeing to pay $4,500,000 and enter into a 3-year Memorandum of Agreement with the DEA.

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• Butzel has received national recognition in the 2023 “Best Law Firms,” rankings by U.S. News & World Report and Best Lawyers. 11.3.2022
• Butzel attorney and shareholder Mitchell Zajac has been appointed Vice Chair of Western Michigan University (WMU) Cooley Law School Board of Directors.  10.28.2022
• Butzel attorney, Claudia Rast will participate in a fireside chat (webcast) on cyber priorities from 11-11:30 a.m. (EST) on Friday, October 28, 2022.  10.27.2022
• Butzel attorney Brett Miller has been named to Michigan Lawyers Weekly’s “Leaders in the Law” Class of 2022. Notably, “Leaders in the Law” have demonstrated tremendous leadership and offer a wealth of expertise in diverse areas o 10.26.2022
• Butzel attorney Beth Gotthelf is among a roster of speakers who will discuss, “Putting Environment, Social & Governance (ESG) Into Practice: Real World Lessons from the Boardroom,” during a webinar Tuesday, November 8, 2022.  10.21.2022
• Butzel attorney, Les Glick invited to give lecture during speaker series presented by Cornell Law School on October 18.  10.13.2022
• Butzel attorney Quendale Simmons has been named to Leadership Detroit’s Class XLIII.  10.5.2022
• Butzel attorney Beth S. Gotthelf will moderate a panel program during the North American Space Summit on October 4, 2022 in Traverse City.  9.28.2022
• Butzel attorney, Debra Geroux has been named to Michigan Lawyers Weekly’s 2022 Honorees for “Influential Women of Law.”  9.21.2022
• Butzel is the presenting sponsor of the Original Equipment Suppliers Association’s OESA 2022 Terms and Conditions Update on Wednesday, September 28, 2022. 9.15.2022
• Butzel attorney, Bushra Malik is chair of the American Immigration Lawyers Association (AILA) 2022 Fall Conference & Webcast on September 11, 2022 in Maui, Hawaii. 9.8.2022
• Butzel attorney, Paul Mersino interviewed on WWJ News Radio on annual backpack giveaway.  9.1.2022
• Butzel attorney and shareholder Leslie “Les” Glick, has been appointed co-chair of the International Trade Committee, American Bar Association (ABA), International Law Section, which is comprised of more than 450 members. 8.31.2022
• Butzel immigration law attorney Reginald Pacis, will participate in a town hall meeting on Tuesday, September 6, 2022 in Troy, hosted by Michigan State Representative Padma Kuppa. 8.24.2022
• Seventy-one Butzel attorneys have been chosen by their peers for inclusion in The Best Lawyers in America® 2023 (copyright 2023 by Woodward/White, Inc. of Augusta, GA).  8.18.2022
• Butzel attorney Thomas Kabel has been elected Chair of the State Bar of Michigan’s Real Property Law Section, which provides education and information on real property law issues through seminars, publications, and networking events, as well as advocacy 8.15.2022
• Butzel immigration law attorney Reginald Pacis, will be featured during a Michigan Asian Pacific American Affairs Commission (MAPAAC) immigration seminar on Saturday, August 13, 2022 in Warren.  8.11.2022
• Butzel attorney Debra Geroux will co-present a webinar titled, “HIPAA Compliance – A Case Study on Reporting Unauthorized Access by Former Employees,” during the State Bar of Michigan’s Health Care Law Section’s (virtual) Annual 8.4.2022
• Butzel attorney and shareholder D. Scott Brinkmann is one of 19 attorneys named to Michigan Lawyers Weekly’s “Go To Lawyers” for Real Estate and Condominium Law for 2022. The program honors leading lawyers in a particular field of law as nom 7.26.2022
• Butzel is a sponsor of a Welcome Reception hosted by the Michigan Aerospace Manufacturers Association in advance of the Farnborough International Airshow (FIA).  7.11.2022
• From year-to-year, Butzel attorneys and practice areas are consistently ranked in the prestigious Chambers USA 2022 – America’s Leading Lawyers for Business 2022 – The Client’s Guide. The firm is among Michigan’s leading law firm 7.5.2022
• Butzel attorney Beth Gotthelf will be featured during a panel program presented by the Michigan Association of Environmental Professionals (MAEP) on Wednesday, June 29, 2022 in Howell. The road map for environmental consultants conducting Phase I ESAs on 6.28.2022
• Butzel is celebrating the news that Industry 4.0 knowledge center Automation Alley, in partnership with the World Economic Forum, has launched the US Centre for Advanced Manufacturing. Notably, Butzel is a founding member of Automation Alley.  6.16.2022
• Butzel attorney Beth Gotthelf is among a group of leaders who will present the keynote opening during the 11th AIPG Michigan Section’s Environmental Risk Management Workshop – Best Practices for Groundwater Remediation and Management, June 14 6.10.2022
• Butzel attorneys Donald V. Orlandoni and David J. DeVine will discuss “Supply Chain Considerations” during a free Michigan Manufacturers Association (MMA) webinar from 8:30-9:30 a.m. (EDT) on Tuesday, June 21, 2022. 6.9.2022
• Butzel attorney Beth Gotthelf was a featured speaker recently during a program presented by the International Women’s Forum (IWF) and Suncoast Forums. 6.6.2022
• Butzel attorney, Claudia Rast is one of five presenters and will serve as the rapporteur for the session entitled, “The Law’s Role in Protecting the Most Vulnerable Populations from Climate Change.” 5.26.2022
• Butzel immigration law attorney profiled by Michigan Asian Pacific Bar Association and Michigan Department of Labor & Economic Opportunity    5.25.2022
• The traditional corporate office paradigm has shifted across industries. Butzel has embraced the opportunity to update its offices, reflecting function, flexibility and culture.  5.24.2022
• Butzel attorney and shareholder Laura Johnson is one of 22 attorneys named to Michigan Lawyers Weekly’s “Go To Lawyers” for Business Law for 2022! 5.11.2022
• Butzel attorney, Mitchell Zajac has been named to DBusiness Magazine's "30 in their Thirties" Class of 2022!  5.5.2022
• Butzel attorney Beth Gotthelf has been appointed Chair of the MMA Environmental Policy Committee. Members actively monitor water, solid waste, remediation and other environmental issue areas to develop environmental policy priorities for MMA. 4.20.2022
• "The Detroit-based Butzel law firm recently did an analysis that warned suppliers of the impact of Stellantis’ changes." Read more on the latest news featuring Butzel attorney, Jennifer Dukarski.  4.13.2022
• Butzel attorney Beth Gotthelf recently participated in Michigan Aerospace Manufacturers Association delegation meeting with top space organizations 4.12.2022
• Butzel immigration law attorney Reginald Pacis, will be a featured panelist during an American Immigration Lawyers Association (AILA) webinar on Thursday, March 31, 2022.  3.29.2022
• Jennifer Dukarski, Butzel attorney, shareholder and leader of the firm’s Connected Car and Autonomous Vehicle Specialty team, is one of 24 attorneys named to Michigan Lawyers Weekly’s “Go-To Intellectual Property Lawyers” list. 3.22.2022
• Butzel attorney John C. Valenti appointed to Better Business Bureau of Detroit & Eastern Michigan Board of Directors 3.21.2022
• Mark Lezotte, co-chair of Butzel’s Health Care Industry Team, will be a featured during the "Healthcare Entities and LLCs: Leveraging IRS Guidance on Requirements for LLCs to Qualify as Tax-Exempt Entities" webinar from 1-2:30 p.m. (EDT) on Wednesday, M 3.10.2022
• Justin Klimko, President and CEO, Butzel, has been named to Michigan Lawyers Weekly’s Hall of Fame Class of 2022. He has received numerous awards and recognitions for business law matters and is ranked as one of Michigan’s leading corporate and M& 3.9.2022
• Butzel attorney and shareholder Javon David has been named to Oakland County’s 2022 Class of 40 Under 40. In its tenth year, 40 Under 40, honors young professionals who live and/or work in Oakland County.  3.8.2022
• Butzel attorney Sarah Nirenberg is one of 22 attorneys in the state named to Michigan Lawyers Weekly’s 2022 Class of “Up & Coming Lawyers.” Attorneys recognized for this honor have distinguished themselves in the practice of law. 3.8.2022
• Butzel immigration law attorney Reggie Pacis, was recently interviewed on the GlobalAutoIndustry.com audio interview series. The topic for the interview: “U.S. Business Immigration: COVID’s Current Effect on Companies and Employees.” 2.10.2022
• Register Today: OESA Breaking the Code: Software Ts and Cs 2022, March 11, 2022 at 8:30am EST. Speakers include Butzel attorneys, Jennifer Dukarski and Mitch Zajac. 2.3.2022
• Butzel attorney Kurtis Wilder has been named to the Executive Committee of the Michigan Chamber of Commerce Board of Directors. The Michigan Chamber of Commerce is Michigan’s leading statewide business advocacy organization with more than 5,000 members. 1.31.2022
• Register today for virtual webinar, "Automotive Industry Outlook: Navigating Disruption in a Time of Industry Transformation" on Wednesday, February 23rd at 3pm EST.  1.27.2022
• Our Automotive Terms & Conditions Team will break down the new Stellantis T/C's for the Original Equipment Suppliers Association membership, next week, Feb. 2nd. Another great benefit of OESA membership! 1.26.2022
• Bushra Malik, Butzel attorney and shareholder, will be featured during the 2022 American Immigration Lawyers Association (AILA) Midwinter Virtual Conference on Thursday, February 3. 1.25.2022
• Butzel is proud to welcome Jude Nwaokobia to the firm. 1.21.2022
• Butzel attorney Claudia Rast will be a featured panelist during the (virtual) Michigan Cybersecurity Conference on January 21, 2022. The topic is “The Power of a Functioning Incident Response Plan." 1.20.2022
• Butzel immigration law attorney Reggie Pacis, has been invited to participate in an “Asian Americans and Pacific Islanders (AAPI) in the Workplace” panel program on Tuesday, January 25, 2022. 1.20.2022
• Butzel is proud to welcome Everardo Tapia to the firm. 1.13.2022
• Read more on the latest new featuring Butzel attorneys, Javon David and Mitch Zajac.  1.10.2022
• Read more on the upcoming speaking engagement for Butzel attorney, Darius Dynkowski.  1.7.2022
• "Protecting Trade Secrets" article written by Butzel attorneys Paul Mersino and Bernie Fuhs appears in Detroiter Magazine.  1.6.2022
• Learn more about what Butzel Long's Charitable Trust has been up to this year! 12.27.2021
• Butzel attorney Jennifer Dukarski to moderate SAE/ NHTSA annual Cybersecurity Workshop on January 18 in Washington, D.C.  12.22.2021
• Learn more on the latest speaking engagement for Butzel attorney, William Kraus.  12.1.2021
• Butzel attorney and shareholder Lynn McGuire has been named Co-Chair of the firm’s Education Industry Team.  11.16.2021
• Seventy-five Butzel attorneys have been named Top Lawyers in metro Detroit 2022 by DBusiness magazine.  11.15.2021
• Congratulations to Butzel attorney, Beth Gotthelf on receiving National Association for Surface Finishing Award of Merit. 11.10.2021
• Butzel has received national recognition in the 2022 “Best Law Firms,” rankings by U.S. News & World Report and Best Lawyers® 11.5.2021
• Butzel attorney Paul Mersino named to Crain’s Detroit Business magazine’s ‘40 Under 40’ 2021 list 11.2.2021
• Congratulations to Butzel attorney Michael C. Decker named to Michigan Lawyers Weekly’s ‘Leaders in the Law’ 10.26.2021
• Congratulations Bushra Malik on being named to 2022 edition of Best Lawyers® in the Midwest ‘Lawyer of the Year.’ 10.20.2021
• Butzel Long attorney, Claudia Rast featured on National Security Law Today Podcast. 10.8.2021
• Butzel attorney, shareholder and vice president Geaneen M. Arends, has been named a 2021 Diversity Business Leader Honoree by Corp! Magazine. 10.5.2021
• Watch Butzel Long attorney Jennifer Dukarski interviewed by Autoline  10.4.2021
• Butzel donates backpacks filled with school supplies to K-8 students at MacDowell Preparatory Academy in Detroit 9.15.2021
• Read more on the latest news featuring Butzel Long attorney, Laura Johnson being named to DBusiness magazine's '30 in Their Thirties'  6.16.2021
• DBusiness runs news article on Butzel Long attorney, Kaveh Kashef being named President of the Oakland County Bar Association.  6.10.2021
• Register today for a complimentary webinar, "Avoiding Mistakes in Running Retirement Plans," on Tuesday, June 22 at noon by Butzel Long employee benefits attorneys, Lynn McGuire and Tom Shaevsky. 6.8.2021
• Read more on the latest Butzel Long news! 6.4.2021
• Check out Butzel Long's latest career opportunity for an Immigration Legal Assistant. 6.4.2021
• Read more on the latest news featuring Butzel Long attorney, Geaneen Arends. 6.2.2021
• Read more on the latest news regarding Butzel Long attorney, Reggie Pacis 6.2.2021
• Register today for a complimentary webinar, "So You Want To Buy A Blockchain Company: Considerations for Corporate Transactions," on Tuesday, June 15th at noon by Butzel Long attorneys, Jennifer Dukarski, Laura Johnson, and William Kraus. 6.2.2021
• Congratulations to Butzel Long attorney, Kaveh Kashef who will be sworn in as the 89th President of the Oakland Bar Association on June 3rd!  https://www.linkedin.com/feed/update/urn:li:activity:6802601337638014976
• Read more on the latest news featuring Butzel Long attorney, Reggie Pacis. 5.19.2021
• Register today for the "OESA 2021 China Market & Shanghai Auto Show Debrief: Charging Ahead" webinar on Wednesday, May 26, 2021. 5.18.2021
• The rapidly increasing use of blockchain technology and other digital assets has given rise to complex regulatory and legal challenges across virtually all industries. Butzel Long has created a specialty team to meet this client need.  5.18.2021
• Read more on the latest news featuring Butzel Long attorney, Geaneen Arends. 5.17.2021
• Read more on the latest news featuring Butzel Long attorney, Shanika Owens. 5.4.2021
• Read more on the latest news regarding Butzel Long attorney, Jim Rosenfeld. 4.28.2021
• Learn more on the latest news regarding Butzel Long attorney, Jennifer Dukarski. 4.20.2021
• Read more on the latest news regarding Butzel Long attorneys, Claudia Rast and Jennifer Dukarski 4.14.2021
• Read more on the latest news regarding Butzel Long attorney, Kurtis Wilder. 4.1.2021
• Congratulation to Butzel Long attorney, Geaneen Arends on being elected to the firm's Board of Directors! 3.30.2021
• Butzel Long President and CEO Justin Klimko to receive the Association for Corporate Growth (ACG) Detroit’s Lifetime Achievement Award later this year. Read the full article on Dbusiness. 3.26.2021
• Automotive Industry Outlook and Contract Terms and Conditions Webinar 3.23.2021
• Check out Butzel Long's latest career opportunity for a Human Resources and Recruiting Coordinator! 3.18.2021
• Bitcoin and Blockchain is the latest buzz of the financial world. Please join us for a complimentary webinar series as Butzel Long attorney, William Kraus digs deeper into the basic, intermediate, and advanced areas of this topic.  3.17.2021
• Check out Butzel Long's latest career opportunity for a Librarian/Information Specialist!  3.15.2021
• Register today for a complimentary webinar, "Cybersecurity Cryptocurrency and Trade Secrets: Protection, Legal Issues, and Business Application," given by Butzel Long attorneys, William Kraus, Claudia Rast, and Brett Miller. 3.9.2021
• Butzel Long attorney Geaneen Arends, and chair of the Diversity, Equity, and Inclusion Committee, featured in the DBusiness Diversity Issue. 3.2.2021
• Check out Butzel Long's latest career opportunity for a Tax Attorney. 2.22.2021
• Butzel Long automotive attorney Jennifer Dukarski, CIPP/US quoted in Forbes article, "The Witness Against You: Your Car." 2.18.2021
• DBusiness runs article on Butzel Long attorney Richard Rassel receiving the Detroit Regional Chamber’s Inaugural Business Leadership in Education and Equity Award.  2.18.2021
• DBusiness runs article on attorneys Louis Ronayne and Quendale Simmons joining the firm!  2.11.2021
• Read the latest interview with Butzel Long attorney Claudia Rast and Law360. 2.9.2021
• Watch ICLE's, Demonstration: Remote Deposition featuring Butzel Long attorney, Paul Mersino. 2.9.2021
• Listen to the latest interview with Butzel Long attorney, Paul Mersino. 2.8.2021
• Congratulations to Butzel Long attorney Richard Rassel, the recipient of the inaugural Business Leadership in Education and Equity Award, presented by the Detroit Regional Chamber on this morning’s State of Education broadcast. 2.8.2021
• Read more on the latest news regarding Butzel Long attorney, Jennifer Dukarski. 2.2.2021
• Butzel Long welcomes Lindsey Dennis to the firm. 2.1.2021
• Read the latest article by Spartan Magazine mentioning Butzel Long attorney, Geaneen Arends. 1.29.2021
• In case you miss our webinar, "A Conversation on Managing Supply Chain Instability" this afternoon, view it now on our YouTube page. 1.28.2021
• DBusiness runs article on Butzel Long attorney, George Donnini. 1.22.2021
• Register Today! Join us on Thursday, January 28th at noon for a complimentary webinar where Butzel Long's automotive industry team will discuss several issues surfacing within the automotive supply chain. 1.21.2021
• Butzel long is proud to welcome Louis F. Ronayne to the firm. 1.20.2021
• Butzel Long attorney Max Newman quoted in Crain's article, "Will Loves Furniture's brief story end in heartbreak?" (Please note this is a subscription based read). 1.11.2021
• Butzel Long welcomes Quendale G. Simmons to the firm. 1.4.2021
• Read more on the latest news regarding Butzel Long attorney, George Donnini. 1.4.2021
• Learn more on what the Butzel Long Charitable Trust has been up to this year in the Butzel Long Charitable Trust's 2020 Year In Review.  12.21.2020
• Dbusiness runs article on Butzel Long attorney Geannen Arends being named practice department chair for Butzel Long’s corporate and real estate practice departments.  12.17.2020
• Butzel Long Connected Car and Autonomous Leader, Jennifer Dukarski featured during SAE International's Connect2Cars@CES Digital Summit. 12.17.2020
• Butzel Long attorney celebrates 18th Adoption Day in Michigan; presents Maura Corrigan Foster Family Lifetime Achievement Award for service to children and families. 12.16.2020
• Butzel Long attorney, Jennifer Consiglio named to Michigan Lawyers Weekly's , "Go To Business Lawyers" list. 12.14.2020
• Congratulations to Butzel Long's technical training specialist, Karen Hirzel, for being featured on The Paul W. Smith Show for the writing and producing of her very own song "Together in Peace."  12.14.2020
• Butzel Long attorney Jennifer Dukarski appointed co-Chair of ABA Forum's Diversity Committee 9.9.2020
• Butzel Long expands Washington, D.C. footprint with addition of four IP attorneys 8.3.2020
• USMCA's July 1 Deadline Looming: Five Major Changes Your Business Needs to Be Aware Of 6.25.2020
• Read more on the latest client alert by attorneys, Damien DuMouchel, David DuMouchel, and George Donnini 5.11.2020
• Read the latest client alert by Butzel Long's Executive Order Analysis Team - Paul Mersino, Justin Klimko, Bernard J. Fuhs, Brett Miller, Jennifer Dukarski, and Mitchell Zajac 5.8.2020
• Butzel Long attorney Thomas Southard quoted in Crain's Detroit Business article on cannabis intellectual property. 10.1.2019
• Butzel Long attorney George Schooff quoted in Crain's Detroit Business on uptick in IP Litigation. 9.30.2019
• Butzel Long attorney David F. DuMouchel appointed to the Magistrate Judge Merit Selection Panel for the U.S. District Court for the Eastern District of Michigan. 9.30.2019
• The Michigan Chronicle news runs article on the Butzel Long and The Kids in Need Foundation backpack donation to students at The Detroit Leadership Academy. 9.25.2019
• Save The Date! Butzel Long's 32nd Annual Labor, Employment, Benefits, and Immigration Law Forum. Registration Opening Soon! 9.9.2019
• Register today for the 2019 Michigan Defense Industry Arsenal of Innovation Reception at the AUSA Annual Exposition! 9.6.2019
• Butzel Long attorney Paul Mersino interviewed by WWJ-AM 950 about backpack donations. 9.5.2019
• Butzel Long attorney Rebecca S. Davies featured during State Bar of Michigan Health Care Law Section's Annual Meeting on September 19, 2019. 9.5.2019
• Butzel Long featured on Fox 2 News last night along with the Kids in Need Foundation! The Detroit Leadership Academy got free backpacks and school supplies on the 1st day of school. 9.4.2019
• Butzel Long attorneys named to 2019 Super Lawyers list! 9.3.2019
• Butzel Long attorney Robin Luce-Herrmann to speak at SPJ of Detroit’s FOIA Festival on the Michigan Freedom of Information Act. 9.3.2019
• Guest article "Is gross negligence a cause of a action under Michigan Law" written by Butzel Long attorney Rebecca Klein appears in this week's edition of Michigan Lawyers Weekly. 8.29.2019
• Butzel Long attorney Robin Luce-Herrmann quoted in the Detroit News. 8.27.2019
• Butzel Long attorneys Beth Gotthelf and Claudia Rast featured during MINASF Midwest Seminar September 12-14, 2019. 8.26.2019
• Butzel Long attorneys named to The Best Lawyers in America® 2020 8.15.2019
• Butzel Long attorney Reggie Pacis interviewed on The Frank Beckmann Show - August 13, 2019 8.13.2019
• Butzel Long attorney's Beth Gotthelf and Claudia Rast to speak at the MINASF Midwest Seminar at the Grand Hotel in Mackinac Island. Register today! 8.11.2019
• Butzel Long Now Accepting Applications for the 2020 Summer Program. 7.26.2019
• The Butzel Long Charitable Trust is proud to share their 2019 Newsletter with everyone! 7.25.2019
• Last chance to register for tomorrow's OESA 2019 Butzel Long Supplier Academy Series II 6.27.2019
• Justices Hold Scandalous Trademark Can Be Federally Registered 6.27.2019
• Painful Reminder That "One-Size Fits All" Restrictive Covenants May Not Be Enforced. 6.25.2019
• Butzel Long attorneys at the fundraiser this morning for Senator Gary Peters. 6.24.2019
• The Butzel Long Charitable Trust was a proud sponsor in the U of D Mercy Titan Athletic Club's Basketball Camp for Kids with ... 6.24.2019
• The Congressional Cannabis Compromise - Introduced legislation says the federal government won't interfere. 6.21.2019
• Butzel Long at the St. Vincent de Paul Golf Outing. 6.21.2019
• Section 301 List 3 China Tariffs Exclusion Process and Exclusion Request Form Finalized by U.S. Trade Representative; ... 6.21.2019
• Butzel Long at 9th Annual UDM Basketball Camp for Athletes with Special Needs! 6.20.2019
• Just in case you missed our webinar this afternoon, please feel free to check it out on our YouTube page! 6.19.2019

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Reporting Prescription Drug Sample Losses, Known Thefts, and Possible Diversion in the Aftermath of a Natural Disaster

Natural Disaster Response

FDA is aware that pharmaceutical manufacturers and authorized distributors may be contacted by sales representatives concerning drug sample losses in the wake of natural disasters. Due to the emergency conditions imposed by natural disasters, FDA intends to exercise enforcement discretion by not initiating a regulatory action on the basis of failure to comply with the 5-day, 30-day, or follow-up reporting timeframes described in the Prescription Drug Marketing Act (PDMA) regulations if manufacturers and authorized distributors submit significant loss reports for such samples in a monthly summary report with a cover letter stating that the losses occurred due to damage from a natural disaster, with an attached list of the names of the involved sales representatives.

FDA's exercise of enforcement discretion is limited to the reporting of prescription drug sample losses caused by natural disasters. Reporting of drug sample known thefts and possible/known diversion remain subject to the investigative, reporting, and timeframe requirements of the regulations under 21 CFR 203.37 .

Beyond Ozempic: New GLP-1 drugs promise weight loss and health benefits

The next wave of obesity drugs is coming soon.

Drug companies are racing to develop GLP-1 drugs following the blockbuster success of Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound.

Some of the experimental drugs may go beyond diabetes and weight loss, improving liver and heart function while reducing side effects such as muscle loss common to the existing medications. At the 2024 American Diabetes Association conference in Orlando, Florida, researchers are expected to present data on 27 GLP-1 drugs in development.

“We’ve heard about Ozempic and Mounjaro and so on, but now we’re seeing lots and lots of different drug candidates in the pipeline, from very early-stage preclinical all the way through late-stage clinical,” said Dr. Marlon Pragnell, ADA’s vice president of research and science. “It’s very exciting to see so much right now.”

A large portion of the data presented comes from animal studies or early-stage human trials. However, some presentations include mid-to late-stage trials, according to a list shared by the organization.

Approval by the Food and Drug Administration is likely years away for most. Some of the drugs showcased could be available for prescription in the U.S. within the next few years.

“We’ve witnessed an unprecedented acceleration in the development of GLP drugs,” said Dr. Christopher McGowan, a gastroenterologist who runs a weight loss clinic in Cary, North Carolina. “We are now firmly entrenched in the era of the GLP.”

While the existing drugs are highly effective, new drugs that are more affordable and have fewer side effects are needed, McGowan added.

There aren’t just GLP-1 drugs in the pipeline. On Thursday, ahead of the diabetes conference, Denmark-based biotech firm Zealand Pharma released data that showed a high dose of its experimental weight loss drug petrelintide helped reduce body weight by an average of 8.6% at 16 weeks.

The weekly injectable medication is unique because it mimics the hormone amylin, which helps control blood sugar. The hope is patients will experience fewer side effects like nausea commonly associated with GLP-1 drugs such as Wegovy and Zepbound.

Can glucagon hormone help with weight loss?

GLP-1 medications work, in part, by slowing down how quickly food passes through the stomach, leading people to feel fuller longer. In several of the upcoming weight loss drugs, a different hormone called glucagon is in the spotlight. Glucagon is a key blood-sugar-regulating hormone that can mimic the effects of exercise.

One of the drugs featured at the conference on Sunday is called pemvidutide, from Maryland-based biotech firm Altimmune .

The drug contains the GLP-1 hormone, a key ingredient in Ozempic and Wegovy, in addition to glucagon.

Altimmune released data from a phase 2 trial of 391 adults with obesity or who are overweight with at least one weight-related comorbidity such as high blood pressure. Patients were randomized to either get one of three doses of pemvidutide or a placebo for 48 weeks.

Researchers found that patients who got the highest dose of the drug lost on average 15.6% of their body weight after 48 weeks, compared to the 2.2% body weight loss seen in patients who got a placebo. In similar trials, semaglutide was shown to reduce body weight by around 15% after 68 weeks.

These are not direct comparisons because the drugs weren’t compared in a head-to-head clinical trial.

Dr. Scott Harris, Altimmune’s chief medical officer, said the drug has been shown to help people lose weight, as well as provide health benefits to the liver and heart. What’s more, the drug has shown benefits in preserving lean body mass. Some studies have suggested that semaglutide, the active ingredient in Ozempic and Wegovy, can cause muscle loss.

“If people take the drugs long term, what’s going to be their long-term health? What’s going to be the long-term effects on their body composition, their muscle, their ability to function?” he said.

Harris said that people who got pemvidutide lost on average 21% of their lean body mass, which is lower than the around 25% of lean body mass people typically lose with diet and exercise.

“We’re the next wave of obesity drugs,” Altimmune President and CEO Vipin Garg said. “The first wave of mechanisms was all driven by appetite suppression. We are adding another component.”

Altimmune expects to begin a phase 3 trial soon. The company hopes the drug will be available in the U.S. sometime in 2028.

Competition could drive down costs

Expanding the number of weight loss drugs available is important for several reasons, experts say.

More options could also help alleviate the shortages seen in the U.S. with Novo Nordisk’s and Lilly’s weight loss drugs.

Latest news on weight loss medications

• Amid shortages, WHO warns about safety risks from fake versions of Wegovy and Zepbound.
• How one state is trying to make weight loss drugs cheaper.
• Weight loss drugs like Wegovy are meant for long-term use. What happens if you stop taking them?

Increased competition could drive down the high cost of the drugs over time. A month’s supply of Wegovy or Zepbound can cost more than $1,000, often financially untenable for many patients, experts say.

Patients can also respond differently to treatments, said Dr. Fatima Cody Stanford, an associate professor of medicine and pediatrics at Harvard Medical School. In fact, some have found the existing GLP-1 options ineffective.

“Different GLP-1 drugs may have varying levels of efficacy and potency,” she said. “Some patients may respond better to one drug over another, depending on how their body metabolizes and responds to the medication.”

Since starting Ozempic in June 2022, Danielle Griffin has not seen the results her doctor predicted. “She really expected to see a huge difference in my weight, and I just never saw it,” said the 38-year-old from Elida, New Mexico. Griffin weighed about 300 pounds and has lost only about 10 pound in two years. She said her “expectations were pretty much shattered from that.”

Amid insurance battles and shortages, she has also tried Wegovy and Mounjaro, but didn’t see a difference in her weight.

“I don’t feel like there are options, especially for myself, for someone who the medications not working for.”

The prospect of new medications on the horizon excites Griffin. “I would be willing to try it,” she said, adding that “it could be life changing, honestly, and you know that alone gives me something to look forward to.”

More drugs in the pipeline

Eli Lilly, which makes Zepbound and the diabetes version Mounjaro, has two more GLP-1 drugs in development.

On Sunday, Lilly released new data about retatrutide, an injectable drug that combines GLP-1 and glucagon , plus another hormone called GIP. GIP is thought to improve how the body breaks down sugar.

In an earlier trial, retatrutide helped people lose, on average, about 24% of their body weight, the equivalent of about 58 pounds — greater weight loss than any other drug on the market.

New findings showed the weekly medication also significantly reduced blood sugar levels in people with Type 2 diabetes.

On Saturday, there were also new findings on the experimental mazdutide, which Lilly has given permission to biotech firm Innovent Biologics to develop in China. The drug combines GLP-1 and glucagon.

In a phase 3 study of adults in China who were overweight or had obesity, researchers found that after 48 weeks, a 6-milligram dose of the drug led to an average body weight reduction of 14.4%.

The drug also led to a reduction in serum uric acid — a chemical that can build up in the bloodstream, causing health problems, and has been associated with obesity, according to Dr. Linong Ji, director of the Peking University Diabetes Center, who presented the findings.

That was “quite unique and never reported for other GLP-1-based therapies,” he said in an interview.

The drug could be approved in China in 2025, Ji said.

Improving metabolic conditions

An estimated 75% of people with obesity have nonalcoholic fatty liver disease and 34% have MASH, or metabolic dysfunction-associated steatohepatitis, according to researchers with the German drugmaker Boehringer Ingelheim. Fatty liver disease occurs when the body begins to store fat in the liver . It can progress to MASH, when fat buildup causes inflammation and scarring.

In a phase 2 trial of people who were overweight or had obesity, Boehringer Ingelheim’s survodutide, which uses both GLP-1 and glucagon, led to weight loss of 19% at 46 weeks. Another phase 2 study in people with MASH and fibrosis found that 83% of participants also showed improvement in MASH.

Survodutide “has significant potential to make a meaningful difference to people living with cardiovascular, renal and metabolic conditions,” said Dr. Waheed Jamal, Boehringer Ingelheim’s corporate vice president and head of cardiometabolic medicine.

On Friday, the company released two studies on the drug. One, in hamsters, found that weight loss was associated with improvements in insulin and cholesterol. The second, in people with Type 2 diabetes or people with obesity, found the drug helped improve blood sugar levels.  

The company is looking to begin a phase 3 trial.

CLARIFICATION (June 24, 2024, 2:31 p.m. ET): Innovent Biologics has entered into an exclusive licensed agreement with Eli Lilly for the development of mazdutide in China, not a partnership.

Berkeley Lovelace Jr. is a health and medical reporter for NBC News. He covers the Food and Drug Administration, with a special focus on Covid vaccines, prescription drug pricing and health care. He previously covered the biotech and pharmaceutical industry with CNBC.

• On the Move

Hims & Hers down 6% following report on weight loss drug (updated)

imyskin/iStock via Getty Images

This article was updated at 1050a ET with comment from the company.

Hims & Hers Health ( NYSE: HIMS ) is down ~6% following a report that is raising eyebrows both on how easy it is to get a prescription for GLP-1 weight loss drugs and the supplier of its compounded versions of those medications.

The company has partnered with a subsidiary of Belcher Pharmaceuticals, which allegedly has a history of run-ins with the U.S. FDA, according to Hunterbrook Media, which is associated with hedge fund Hunter Capital. The latter is short on the stock.

Hims & Hers has been on a tear since announcing May 20 it would sell cheaper, compounded versions of semaglutide, the active ingredient in Novo Nordisk's ( NVO ) Wegovy. It boasted semaglutide could cost as little as $199 month, while branded Wegovy has a list price of ~$1349 month.

Because Wegovy and Eli Lilly's ( LLY ) competing drug, Zepbound (tirzepatide) are currently in shortage, the U.S. FDA has allowed compounding pharmacies to make knock-off versions, even though they are not formally approved by the agency.

Two doctors Hunterbrook spoke with expressed concern that the compounded versions Him & Hers ( HIMS ) are hawking may be inferior to or not as effective as the brand name versions, leading potentially to problems for those that take them.

The Hunterbrook report also said that one of its writers qualified for a semaglutide prescription after filling out a four-minute survey and was given a prescription within an hour, even though she never spoke with a doctor or submitted medical records.

A Hims and Hers ( HIMS ) spokesperson pointed Seeking Alpha to a post on its website. "We rely on the healthcare providers on the platform to determine the best solution for their patients -- even if that solution isn't available on Him & Hers."

A second post from Chief Medical Officer Pat Carroll discusses the company's commitment to the safety of its compounded medications. "Being a partner in our customers' health and wellness journeys is a responsibility we take seriously."

More on Hims & Hers Health

• Hims & Hers: Buy The Dip To Catch The Next Rip
• Hims & Hers: The Undervalued Gem Poised For Growth
• Hims & Hers: Compounded Semaglutide Boost Unlikely To Last - Moderate Risks Ahead
• Hims & Hers defended at BofA as Lilly fights compounded GLP-1s
• Hims & Hers cut to Neutral at Citi on recent rally

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Presidential debate fact check: What Trump, Biden got right (and wrong)

President Joe Biden and former President Donald Trump both strayed repeatedly from the truth as they squared off in the first presidential debate of the 2024 election season.

Here are the claims the USA TODAY Fact Check Team dug into.

Biden claim: We lowered the cost of an insulin shot from $400 to $15

“We brought down the price of prescription drugs, which is a major issue for many people, to $15 for – for an insulin shot, as opposed to $400.”

This is false. The Inflation Reduction Act that Biden signed into law in August 2022 capped the out-of-pocket cost of insulin at $35 a month for all seniors on Medicare, according to the White House . Several pharmaceutical companies , including Eli Lilly , followed suit and limited the monthly cost of the drug to $35 per month as well. But there is no evidence Biden limited the cost of insulin beyond this.

The price of insulin was also never set at $400, though many paid about this much. The price a person pays for insulin depends on a variety of factors, including what type of insulin they are using, insurance status and whether they're eligible for a rebate from the drugmaker, according to NBC News . While estimates vary, one government study published in December 2022 reported that in 2019 , the average insulin user with private insurance spent $456 on insulin annually, while those with Medicare spent $449 a year and those without health insurance paid $996, comparatively. 

-Brad Sylvester

Biden claim: He is endorsed by Border Patrol agents

“The border patrolmen endorsed me, endorsed my position.”

This is partly false.

The National Border Patrol Council – the labor union that represents more than 18,000 U.S. Border Patrol agents – posted to X, formerly Twitter , minutes after Biden made the claim and said, “To be clear, we never have and never will endorse Biden.”

But the union, which endorsed Trump in 2020, supported the proposed bipartisan border agreement that Biden backed and Trump opposed, NBC News reported in February.

– Joedy McCreary

Biden claim: Illegal border crossings dropped 40% after his June directive

“I've changed (the law) in a way that now you're in a situation where there are 40% fewer people coming across the border illegally.”

Biden took executive action on June 4 that authorized the U.S. to turn away migrants who enter the country illegally when crossing levels are high. The policy is triggered anytime unlawful crossings hit an average of 2,500 people a day in a given week.

In remarks posted on June 26 , Homeland Security Secretary Alejandro N. Mayorkas said Border Patrol encounters along the U.S.-Mexico border had dropped by over 40% since Biden took action.

However, immigration experts have cautioned that it’s difficult to point to any one reason for a drop in crossings at the border, PolitiFact noted in its fact check on this claim .

Immigration rights organizations have sued the Biden administration over the new asylum restrictions at the border.

–Andre Byik

Trump claim: Everybody wanted Roe v. Wade overturned

“I put three great Supreme Court justices on the court, and they happened to vote in favor of killing Roe v. Wade and moving it back to the states. This is something that everybody wanted.”

This is not an accurate summary of public opinion on the question. Numerous polls show most Americans were not in favor of the Supreme Court overturning Roe v. Wade in June 2022 . For example, a poll conducted by Pew Research Center in July 2022 found that 57% of respondents said they disapproved of the overturning of the landmark decision. Another PBS NewsHour/NPR/Marist poll conducted in May 2022 (before the case was decided) found that 64% of respondents were opposed to reversing Roe v. Wade.

There is little evidence opinions have changed much since the decision. A Marquette Law School poll conducted in February 2024 found that 67% of adults opposed the ruling, while a Gallup poll from June 2023 found that 60% of respondents said overturning Roe v. Wade was a “bad thing.” 

- Brad Sylvester

Biden claim: Historians voted Trump ‘worst’ president in history

“(Trump) was the worst in all of American history. … He can argue (the historians) are wrong, but that’s what they voted.”

Biden was presumably referring to the 2024 Presidential Greatness Project Expert Survey , which is a joint project from University of Houston professor Brandon Rottinghaus and Coastal Carolina University professor Justin Vaughn .

The survey respondents in late 2023 voted Trump the lowest in “overall presidential greatness,” behind James Buchanan, Andrew Johnson and Franklin Pierce. Abraham Lincoln was rated highest. Joe Biden ranked at No. 14.

Respondents included scholars who had recently published peer-reviewed academic research in related scholarly journals or academic presses and current and recent members of the Presidents & Executive Politics Section of the American Political Science Association, which the survey described as “the foremost organization of social science experts in presidential politics.”

Out of 525 respondents invited to participate, the survey received 154 usable responses, yielding a 29% response rate.

– Andre Byik

Trump claim: I brought in National Guard during 2020 Minnesota unrest

“If I didn’t bring in the National Guard, that city (Minneapolis) would have been destroyed.”

It was Minnesota Gov. Tim Walz, a Democrat, who activated the state’s National Guard to respond to unrest following the death of George Floyd, according to a press release issued by Walz’s office on May 28, 2020.

Walz said at the time that he was responding to “local leaders’ request for Minnesota National Guard assistance to protect peaceful demonstrators, neighbors and small businesses in Minnesota.”

CNN reporter Daniel Dale also looked into the claim back in 2020, detailing the timeline of events provided to the network by Walz’s press secretary, Teddy Tschann. In a statement to CNN, Tschann said Walz activated the National Guard at the request of the mayors of Minneapolis and St. Paul, before the governor spoke with the White House.

“Did President Trump ‘call out’ the Guard? No,” Tschann said in the statement, according to CNN.

On May 30, 2020, the Minnesota National Guard posted on Twitter, now X, that Walz had “ announced the full mobilization ” of the Guard for the first time since World War II.

Biden claim: Trump praised Hitler, saying he did 'some good things'

"This is a guy who says Hitler has done some good things"

Biden's quote of Trump is a reference to comments the former president allegedly made while talking with his White House Chief of Staff, John Kelly, in 2018 during a trip to Paris, according to excerpts from an upcoming book by Wall Street Journal reporter Michael Bender.

“Well, Hitler did a lot of good things,” Trump reportedly told Kelly, according to a CNN report .

Trump later denied that he made the comments and denied that the conversation took place. Liz Harrington, a Trump spokesperson, told CNN the claim is "totally false."

"President Trump never said this," Harrington said. "It is made up fake news, probably by a general who was incompetent and was fired."

Trump has previously faced criticism for saying immigrants are “poisoning the blood of our country” and describing his political opponents as "vermin," reminding many of language used by authoritarian leaders .

- Chris Mueller

Trump claim: Record ‘approval rating’ from VA

“I had the highest approval rating in the history of the VA.”

This is both false and a mischaracterization of what the quarterly customer experience surveys from the U.S. Department of Veterans Affairs measure.

The Veteran Signals surveys track the proportion of servicemembers who express having trust in the VA. It's not a presidential approval rating.

It has topped 80% twice: It was at 80% in 2020 during Trump’s administration , and it reached a high of 80.4% in May under Biden.

Trump made a similar version of the claim during a May rally in Wisconsin , according to a report from Wisconsin Watch.

Trump claim: More illicit drugs coming into US under Biden

“The number of drugs coming across our border now is the largest we’ve ever had by far.”

This is false. When measured by weight, drug seizures are trending down.

The U.S. Customs and Border Protection’s Border Patrol and Office of Field Operations seized nearly 549,000 pounds of illicit drugs in 2023 , according to federal data. That’s down 16% from 2022, when 656,000 pounds of substances were confiscated. More than 900,000 pounds were seized in 2021, according to federal data.

Most of the drugs involved were marijuana (150,000 pounds) and methamphetamine (140,000 pounds).

Fentanyl seizures were up, however, with the 27,000 pounds in 2023 accounting for nearly twice the 14,700 pounds confiscated in 2022.

Trump claim: Biden indicted me because I’m his political opponent

“He [Biden] indicted me because I'm his opponent.”

This is false. Trump was indicted and convicted in New York for falsifying business records related to a $130,000 hush money payment to adult film actress Stormy Daniels ahead of the 2016 election. But there is no evidence Biden or his administration had anything to do with these charges. Since the charges were brought by the state of New York , Biden and the federal government are not party to the indictment and have no say in the charges, as USA TODAY previously reported .

“When you’re dealing with state prosecutions, it’s district attorneys elected by the voters of their jurisdiction,” said Allan Lichtman , a professor of history at American University. “That has nothing to do with the federal government.”

The idea of Biden interfering in Trump's prosecution is further weakened by the fact that the agency under his purview declined to file charges. The Justice Department had the authority to pursue a case against Trump over the hush money circumstances but chose not to do so.

In Trump's two federal cases, things are a bit different. The charges he faces cover the  hoarding of hundreds of classified documents  in Florida and a  conspiracy to steal the 2020 election  from Biden in Washington.

There is no law that prohibits a president from involving himself in a federal case, experts acknowledged. But they also said Biden has kept himself separate from the prosecution of Trump .

Additionally, Biden publicly vowed not to speak to Attorney General Merrick Garland about any specific case. And a key reason for the November 2022 appointment of Jack Smith as special counsel for the federal cases against Trump was to add a layer of separation between the investigation and the Biden Administration.

- Brad Sylvester and Joedy McCreary

Trump claim: Food prices have 'doubled and tripled and quadrupled' under Biden

"You look at the cost of food where it's doubled and tripled and quadrupled."

The cost of food has gone up under Biden, but not to the extent Trump claimed. 

The U.S. Department of Agriculture's all-food consumer price index shows food prices rose by 25% from 2019 to 2023. 

The COVID-19 pandemic caused changes in consumer behavior and led to supply chain disruptions, driving large increases in some foods. In 2022, food costs increased faster than any year since 1979, "partly due to a highly pathogenic avian influenza outbreak that affected egg and poultry prices," according to the department's report.

But grocery prices have stabilized over the last year , increasing by just 1.2% in the past 12 months, according to the Consumer Price Index report from March 2024.

Trump claim: No sex with porn star

“I didn’t have sex with a porn star.”

This is disputed.

On May 30, a New York state jury found Trump guilty on 34 felony counts of falsifying business records tied to a hush money payment to porn star Stormy Daniels. Daniels testified at trial that she had sex with Trump in July 2006 following a celebrity golf tournament in Lake Tahoe.

Trump has denied the sex happened.

The trial focused on a $130,000 payment that was arranged by Trump’s then-personal lawyer, Michael Cohen, ahead of the 2016 presidential election, the Associated Press reported.

Trump claim: Biden called African Americans ‘super predators’

"He did a crime bill. 1994. Where you called them super predators. African Americans. Super predators. And they've never forgotten it. They've never forgotten it."

While Biden once warned of “predators” in 1993 while advocating for a 1994 crime bill he sponsored as a senator, he never referred to African Americans as “super predators.” Rather, it was then-first lady Hillary Clinton who linked that term to the 1994 crime bill, as USA TODAY previously reported

While campaigning for her husband in 1996, Clinton praised the 1994 crime bill for curbing gangs, saying, "We need to take these people on, they are often connected to big drug cartels, they are not just gangs of kids anymore. They are often the kinds of kids that are called super predators. No conscious, no empathy,"

Notably, she did not connect this comment to Black people. 

Trump claim: Unprecedented numbers of murders by immigrants under Biden

“People are coming in and they’re killing our citizens at a level that we’ve never seen.”

While Trump has made a version of this claim before, there is no data that points to a wave of homicides being led by people living illegally in the U.S.

A review of 2024 crime data by NBC News suggests the opposite might be true. Overall crime levels have fallen in cities where a Texas program has transported migrants from the border, the network reported in February.

Crime is down year over year in Philadelphia , Chicago , Denver , New York and Los Angeles, according to the report. Washington experienced an increase, but officials do not attribute that spike to migrants, NBC News reported.

Trump previously made a version of the claim during a speech in Eagle Pass, Texas .

Research suggests immigrants actually commit fewer crimes than people born in the U.S.

Trump claim: The US southern border is the most dangerous place in the world

“ We have a border that's the most dangerous place anywhere in the world ”

This is false. While deaths, disappearances and violence do occur at the U.S. southern border, there is no evidence to suggest it is the most dangerous place in the world.

Statistics on border deaths vary. Customs and Border Protection data shows 171 people died at the border in fiscal year 2022, some in CBP custody and others while attempting to cross the border. The International Organization for Migration , a U.N.-related organization , documented 686 deaths and disappearances of migrants on the US-Mexico border in 2022.

Places all over the world and even in the U.S. have more frequent deaths. For example, there were more than 700 murders in Chicago in 2022 , according to the Chicago Police Department. Chicago is 228 square miles , while the U.S.-Mexico border is 1,951 miles long.

Trump claim: Corporate tax cut from 39% to 21%

“The corporate tax was cut down to 21% from 39% plus beyond that.”

Trump was off with one of his numbers. 

The Tax Cuts and Jobs Act of 2017 did lower the corporate tax rate to 21% . But it started at 35%, not the 39% that Trump claimed.

It is unclear exactly what Trump meant with his reference to “plus beyond that.” He promised business leaders that he would lower the corporate tax rate to 20% , The New York Times reported June 13.

Biden claim: Trump told Americans to inject bleach to treat COVID-19

"He said it’s not that serious, just inject a little bleach in your arm, you’ll be all right."

Biden is referring to comments Trump made during a press conference early in the pandemic when he suggested disinfectants might be a possible treatment for COVID-19. But he overstates what Trump said.

Trump's statement came after Bill Bryan, an undersecretary of science and technology at the Department of Homeland Security, discussed a new study that found sunlight and household disinfectants effectively killed the virus on surfaces or in the air.

"And then I saw the disinfectant, where it knocks it out in one minute, and is there a way we could do something like that by injection inside or almost a cleaning," Trump said.

Trump, though, never directly instructed people to inject bleach or any other disinfectant. Some states issued warnings following Trump's comment, as did Lysol, which told people not to inject or ingest its products as a coronavirus treatment.

Biden claim: No American troops died anywhere in the world during his presidency

“The truth is, I’m the only president this century that doesn’t have any - this decade - that doesn’t have any troops dying anywhere in the world, like (former President Donald Trump) did.”

Biden’s comment came following a reference to hostilities in Afghanistan during Trump’s term in office.

But the notion that no troops have died in the world during Biden’s time in office is wrong.

Thirteen U.S. service members were killed in a suicide bombing attack near the Hamid Karzai International Airport in Kabul in August 2021, when Biden was president, as thousands tried to flee the Taliban’s takeover of the country, USA TODAY previously reported.

Among the deaths were 11 Marines, one Navy hospital corpsman and one Army soldier.

Biden remarked on the deaths at the time, calling them “tragic.”

More recently, three U.S. Army Reserve soldiers were killed in January at a base in Jordan in what was described as a drone attack by Iran-backed militants.

Debate background: Hunter Biden's ongoing legal troubles sure to hang over campaign

In early June, a jury found Hunter Biden – Joe Biden's son – guilty of three federal gun charges, making him the first child of a sitting president to be convicted at trial. The situation has been politically charged as it coincides with the elder Biden's ongoing campaign for reelection. 

Republican lawmakers have investigated Hunter Biden's foreign business deals , repeatedly alleging that Joe Biden was involved in influence peddling during his time as vice president. The White House has denied that allegation , calling it baseless innuendo.

Joe Biden, who earlier said he wouldn't pardon his son , released a statement shortly after the jury's verdict was announced reiterating that position.

“I will accept the outcome of this case and will continue to respect the judicial process as Hunter considers an appeal,” he said. “Jill and I will always be there for Hunter and the rest of our family with our love and support. Nothing will ever change that.”

Hunter Biden is expected to stand trial again in September in California, where he faces tax charges.

But even before his legal troubles, the president's son has been a frequent target for misinformation. Here are some of the claims we've already debunked:

• Fact check roundup: After Hunter Biden's guilty verdict, a look back at viral falsehoods
• Claim: Video shows Hunter Biden on the day cocaine was discovered in the White House (False)
• Claim: Hunter Biden’s prison term has been announced (False)
• Claim: Kodak Black and Hunter Biden faced the same charge, but only Black was sentenced to prison (False)
• Claim: Hunter Biden was seen nude on hotel surveillance, chasing and dragging woman (False)
• Claim: Image shows Trump statement on Hunter Biden conviction (Altered)

Debate background: Vast differences between Biden, Trump on gender identity, LGBTQ+ issues

With Pride Month winding down, LGBTQ+ issues – specifically, those related to gender identity – remain pivotal for voters in both parties.

The candidates have taken widely different positions on those issues, with President Joe Biden – hailed as the most LGBTQ-friendly president in U.S. history – marking his first day in office with an executive order on LGBTQ rights .

His administration is challenging Tennessee’s ban on gender-affirming care for minors, with the Supreme Court agreeing to hear the case . He also unveiled in April a set of sweeping changes to Title IX rules that protect LGBTQ+ students from discrimination based on their gender identity, but a federal judge blocked their enforcement in four states .

Meanwhile, former President Donald Trump vowed in May to roll back transgender student protections “on Day 1” of his presidency by reversing an executive order issued by Biden in 2021. Trump also vowed in February 2023 to punish medical professionals and facilities that provide gender-affirming care to transgender minors and said he would support banning transgender women from women’s sports .

Here are some of the false claims related to LGBTQ+ issues that we’ve debunked:

• Claim: NFL coach Mike Tomlin directed team not to participate in Pride Month activities (False)
• Claim: Biden replaced Easter Sunday with Transgender Day of Visibility (False)
• Claim: Joe Biden said he supports allowing kids to have ‘transgender surgery’ at town hall event (False)
• Claim: A Michigan bill would make using a person’s wrong gender pronouns a felony (False)
• Claim: UN chief says Christians who don’t accept pedophilia will be excluded from society (False)
• Claim: Video shows Disney executive announcing company's new pediatric transgender clinics (False)

Debate background: Israel’s war against Hamas sparks unrest in US as peace deal remains elusive

The Hamas attacks on Israel on Oct. 7, 2023, and Israel’s bombardment of the Gaza Strip in response, plunged President Joe Biden into the second major international conflict of his term. He has been forced to balance America’s military support for Israel with calls from the left to broker a ceasefire deal as casualties mount in the Palestinian territory.

Biden said in May that it is “ time for this war to end and for the day after to begin ,” laying out a proposal that called for Israel to cease military operations in the Gaza Strip and Hamas to release hostages in exchange for the release of hundreds of Palestinian prisoners.

But a peace deal has proved elusive , leading to unrest on college campuses across the country after pro-Palestinian demonstrators set up protest camps. Former President Donald Trump cheered police crackdowns on demonstrators, calling them “ a beautiful thing to watch .” But he’s also called on Israel to finish its war, saying the violence is hurting its standing among the international community.

“Israel has to be very careful, because you're losing a lot of the world, you’re losing a lot of support, you have to finish up, you have to get the job done,” Trump told Israeli outlet Israel Hayom in an interview posted in March. "And you have to get on to peace, to get on to a normal life for Israel, and for everybody else.”

These are some claims related to the Israel-Hamas war that we’ve already addressed:

• Claim: Video shows American actress Candice King condemning Rafah “massacre” (False)
• Claim: Indonesia announced it will send troops to protect Palestinians from Israel (False)
• Claim: Image shows ‘mass exodus’ at Ben Gurion Airport amid Israel-Hamas war (False)
• Claim: Israel defense minister announced Israel has “abolished all the rules of war” (False)
• Claim: Video shows a child’s injuries being faked in Israel-Hamas conflict (False)

Debate background: Russia’s invasion of Ukraine puts spotlight on US involvement in foreign wars

Russia’s war against Ukraine entered its third year in February, and the conflict has had political implications in the U.S., where pushes to approve war aid for Ukraine have been met with contentious debate over the extent of American involvement in foreign wars, the Associated Press reported.

President Joe Biden has remained committed to supporting Ukraine and its effort to join NATO, signing a 10-year bilateral security agreement with Ukrainian President Volodymyr Zelenskyy on June 13.

“Our goal is to strengthen Ukraine’s credible defense and deterrence capabilities for the long term,” Biden said at a press conference about the agreement. “A lasting peace for Ukraine must be underwritten by Ukraine’s own ability to defend itself now and to deter future aggression anytime … in the future.”

Former President Donald Trump has said he could end the war within 24 hours of returning to the Oval Office, but he’s offered few details about his plan. The Washington Post reported Trump’s plan could include pressuring Ukraine to give up territory, which Ukraine has opposed.

Here are some fact-checks about claims related to the war in Ukraine:

• Fact check roundup: What's true and false two years after Russia's invasion of Ukraine
• Claim: Video shows Russian military activity 66 miles off Florida coast (False)
• Claim: Italy's Meloni said Russia will be forced to surrender in Ukraine summit speech (False)
• Claim: Image shows Ukrainian girls “recruited into the military” (False)

Debate background: Fight over immigration reform plays out during presidential campaign

Immigration has become one of the most heated topics of the 2024 election, as President Joe Biden grapples with high levels of crossings at the U.S.-Mexico border and former President Donald Trump vows to deport millions of migrants if re-elected.

The situation at the Southwest border – where U.S. Customs and Border Protection recorded nearly 2.5 million migrant encounters in fiscal 2023 – prompted Biden to take executive action earlier this month to implement new restrictions on asylum access .

The action came after Republican lawmakers in February blocked an immigration bill blocked by Biden that would have revamped the country’s immigration and border policies.

Biden blamed the legislation’s failure to gain traction in Congress on opposition from Trump.

“Now, all indications are this bill won't even move forward to the Senate floor,” Biden said at the time . “Why? A simple reason. Donald Trump. Because Donald Trump thinks it's bad for him politically.”

Meanwhile, Trump has pledged to reinstate policies from his first term in office and limit asylum access if elected in November. He also wants to institute a merit-based immigration system and deputize the National Guard and local law enforcement “to assist with rapidly removing illegal alien gang members and criminals,” according to his campaign website.

Here are some immigration-related claims we previously debunked:

• Claim: Nearly 11,000 “illegals” were processed in Eagle Pass, Texas, in one day in mid-March 2024 (False)
• Claim: Nikki Haley opposed a wall on the US border (False)
• Claim: The Texas National Guard has deployed tanks to the border with Mexico (False)
• Claim: Putin said in Carlson interview that Russians find it ‘amusing’ US protects foreign borders, but not its own (False)
• Claim: Video shows US trucker convoy traveling to southern border to stop migrant “invasion” (False)

Debate background: Biden and Trump face age-related concerns, though both insist they're fit to serve

At 81 years old, Joe Biden is currently the oldest U.S. president ever elected . His age has been a concern for voters and a frequent target for critics, including Donald Trump, who often suggests Biden's age makes him unfit to be president. 

Trump is 78 years old , three years younger than Biden, but he has also faced criticism related to his age and mental acuity, including when he confused Joe Biden for Barack Obama in multiple campaign speeches. 

Either man would be the oldest person to take the oath of office if sworn in next January.

In February, Justice Department special counsel Robert Hur released a report indicating Biden wouldn't face charges for his handling of classified documents that included multiple comments about Biden's age and memory, describing him as an elderly man with "diminished capacities," including memory loss. However, Biden and his administration pushed back , with Biden saying his "memory is fine" during a televised speech.

While Trump's doctor said multiple times he was healthy during his presidency, there were – and still are –  reports of him slurring words during his speeches. Late in his term, Trump was recorded slowly descending a ramp after a speech at at U.S. Military Academy at West Point, during which he used both hands to drink a glass of water. Trump dismissed concerns raised about his age after that incident, claiming the ramp was long, steep and "very slippery."

Here are a few of the age-related claims we've already addressed:

• Claim: Image shows Trump needed help to walk across stage (False)
• Claim: Biden demanded he 'not have to stand' during debate with Trump (False)
• Claim: Video shows Biden tried to sit in a nonexistent chair at D-Day ceremony in France (False)
• Claim: Biden agreed to resign if he fails a cognitive test (False)
• Claim: Joe Biden was declared 'mentally unfit' to stand trial (False)

Debate background: Election integrity remains key issue – even without evidence of widespread voter fraud

Throughout the campaign one question has persisted: Will the candidates and their supporters trust – and abide by – the results of the election?

Most recently, former President Donald Trump’s campaign and the Republican National Committee led by his daughter-in-law said they will mobilize 100,000 people in battleground states to ensure “transparency and fairness.” The move has drawn criticism from opponents who say it has the potential to lead to voter intimidation .

State-level recounts, reviews and audits of the 2022 midterm elections found no indication of systemic problems with voter fraud. That’s significant because baseless allegations from Trump and his allies have penetrated the Republican Party and eroded confidence in the process.

Claims questioning the integrity of the election frequently center around a handful of predictable themes that include assertions of widespread voter fraud and election “hacking .”

USA TODAY has debunked several false claims about the integrity of the elections:

• Fact check roundup: False claims about election fraud, candidates swirl amid 2022 midterms
• Claim: 105% of Michigan’s population is registered to vote (False)
• Claim: A software company's contract allows officials to override election results (False)
• Claim: Malware, remote access caused printer problems; 200,000 'ejected' ballots in Arizona (False)
• Claim: A chart shows election fraud in the Michigan AG’s race (False)
• Claim: Blackout in live stream in Nevada points to election theft (False)
• Claim: Fraud due to Texas voting machine adding voters as polls close (False)
• Claim: Photo showing ballots from 2022 midterms in the trash is evidence of fraud (False)
• Claim: Democrats used 47 million mail-in ballots to steal every election (False)
• Claim: Joe Biden did not legally win the presidential election (False)

Debate background: Trump’s conviction, pending trials loom over debate, election

The first former U.S. president convicted of a felony will take the debate stage as an ex-president for the first time in an attempt to convince voters to give him his old job back.

Former President Donald Trump’s felony conviction and his three pending criminal trials continue to loom large over both the race and the debate – his first of the presidential election cycle – with President Joe Biden.

Trump was convicted of 34 counts of falsifying business records related to hush-money payments intended to silence two women , including adult film actress Stormy Daniels, before the 2016 election. Days before the debate, the judge in that case lifted the gag order restrictions that protected the witnesses and jurors. He is scheduled to be sentenced July 11 – days before the start of the Republican National Convention , during which he is expected to formally receive the party’s nomination.

Trump also faces charges for allegedly mishandling classified documents and allegedly conspiring to steal the 2020 presidential election , including his role in the Jan. 6 insurrection . Trump and several allies were indicted in August by a Georgia grand jury that accused them of trying to overturn his 2020 election loss in the state, where Trump lost to President Joe Biden by about 12,000 votes.

Trump’s legal problems have been the subject of an array of false or misleading claims on social media:

• Fact check roundup: Donald Trump guilty verdict spurs false claims
• Claim: The jury in Trump's hush money trial did not need a unanimous verdict to convict (False)
• Claim: Trump ‘blew off his post-sentencing probation report ’ (False)
• Claim: Justice Juan Merchan was ‘fired’ after jury in Trump hush-money trial illegally leaked verdict (False)
• Claim: Texas Constitution prohibits Trump from running for president (False)
• Claim: Post implies Biden can pardon Trump (Missing context)

More from the Fact-Check Team: How we pick and research claims | Email newsletter | Facebook page

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In States That Won’t Pay for Obesity Drugs, ‘They May as Well Have Never Been Created’

Public employees in West Virginia who took the drugs lost weight and were healthier, and some are despondent that the state is canceling a program to help pay for them.

By Oliver Whang

Reporting from Pineville, Charleston and Morgantown W.Va.

Joanna Bailey, a family physician and obesity specialist, doesn’t want to tell her patients that they can’t take Wegovy, but she has gotten used to it.

Around a quarter of the people she sees in her small clinic in Wyoming County would benefit from the weight-loss medications, which also include Ozempic, Zepbound and Mounjaro, she says. The drugs have helped some of them lose 15 to 20 percent of their weight. But most people in the area she serves don’t have insurance that covers the cost, and virtually no one can afford sticker prices of $1,000 to $1,400 a month.

“Even my richest patients can’t afford it,” Dr. Bailey said. She then mentioned something that many doctors in West Virginia — among the poorest states in the country, with the highest prevalence of obesity, at 41 percent — say: “We’ve separated between the haves and the have-nots.”

Such disparities sharpened in March when West Virginia’s Public Employees Insurance Agency, which pays most of the cost of prescription drugs for more than 75,000 teachers, municipal workers and other public employees and their families, canceled a pilot program to cover weight-loss drugs.

Some private insurers help pay for medications to treat obesity, but most Medicaid programs do so only to manage diabetes, and Medicare covers Wegovy and Zepbound only when they are prescribed for heart problems.

Over the past year, states have been trying, amid rising demand, to determine how far to extend coverage for public employees. Connecticut is on track to spend more than $35 million this year through a limited weight-loss coverage initiative. In January, North Carolina announced that it would stop paying for weight-loss medications after forking out $100 million for them in 2023 — 10 percent of its spending on prescription drugs.

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