Recently, the U.S. Food and Drug Administration (FDA) confirmed that it is investigating allegations that a 60 Minutes segment on the popular body weight loss drug Wegovy was actually an advertisement promoting the semaglutide medication on behalf of its manufacturer, Novo Nordisk. According to an article published by the Physicians Committee for Responsible Medicine (PCRM), the FDA initiated its investigation after the PCRM filed a complaint alleging that the 60 Minutes piece violates the FDA’s “fair balance” standards, which require that advertisements include “information about drug risks as compared with information about drug benefits,” like balancing the piece with information about the benefits of a diet and exercise program, such as a reduced calorie diet, as an alternative to the weight loss drug.

In addition, the potential risk of thyroid c cell tumors, thyroid tumors, acute kidney injury, multiple endocrine neoplasia syndrome type 2, diabetic retinopathy, suicidal behavior, difficulty swallowing, kidney disease and medullary thyroid carcinoma, as well as the side effects of the drug such as low blood sugar, among other things, were not discussed during the program.

As the PCRM article goes on to state:

“After receiving advertising payments from Novo Nordisk, CBS’s 60 Minutes aired a 13-minute promotion of Wegovy, the Novo Nordisk weight loss drug, during its Jan. 1 broadcast, making it appear to be a news story. . . . The 60 Minutes program looked like a news story, but it was effectively a drug ad. . . . Only experts paid by Novo Nordisk appeared in the CBS coverage[ and n]o alternative methods for weight loss were mentioned in the reporting.”

As Wegovy and Novo Nordisk’s other semaglutide chronic weight management drug, Ozempic, have seen a significant increase in demand thanks to recent media coverage, CBS (which publishes 60 Minutes) and other media outlets have also reported on “Wegovy and Ozempic shortages” according to the PCRM. In light of the media-driven demand for semaglutide chronic weight management drugs and the FDA’s reported investigation into Novo Nordisk’s marketing practices, healthcare providers who prescribe and dispense these medications may be at risk of facing FDA scrutiny as well.

“The FDA regularly investigates drug manufacturers and healthcare providers in relation to their marketing, prescription, and dispensing practices. With the FDA looking into Novo Nordisk’s marketing practices related to Wegovy and Ozempic, we are anticipating that the next wave of FDA investigations may target providers who prescribe and dispense these semaglutide drugs. ” – Dr. Nick Oberheiden, Founding Attorney of Oberheiden P.C.

Given the FDA’s focus on semaglutide chronic weight management prescription drugs, which were only FDA approved for those with a personal or family history of obesity, high blood pressure, or other weight related condition, now is the time for providers who market, prescribe, and dispense these drugs to review their FDA compliance efforts. There are several aspects to FDA compliance for healthcare providers, and being able to proactively demonstrate compliance with on-hand documentation is one of the best ways to avoid unnecessary consequences in the event of an FDA inquiry. Providers that are not able to demonstrate compliance with all pertinent laws and regulations could face substantial risks in the event of an FDA investigation—including the risk of criminal prosecution in some cases.

Understanding (and Preparing for) the Risks of an FDA Semaglutide Investigation

Healthcare providers need to address several compliance-related issues in order to avoid (and successfully defend against) unwanted scrutiny from the FDA. With this in mind, here are 10 tips physicians, pharmacists, and other healthcare providers can use to prepare for the possibility of an FDA semaglutide (i.e., Ozempic or Wegovy) investigation:

1. Review Your Practice’s or Pharmacy’s Compliance Program

Providers that market, prescribe, and dispense semaglutide body weight loss medication and diabetes medication should take the opportunity to review their compliance programs before the FDA comes calling. Not only can being able to demonstrate good-faith compliance efforts help steer an FDA investigation toward a favorable resolution, but addressing any semaglutide-related compliance failures before they come to the FDA’s attention can further mitigate targeted providers’ legal risks. Depending on the allegations the FDA chooses to target, these risks can include civil fines, professional disciplinary action, and even prosecution for criminal healthcare fraud.

2. Focus Specifically on FDA Compliance

When reviewing your business’s or practice’s compliance program in anticipation of a possible FDA investigation, it is important to focus specifically on FDA compliance. The FDA enforces obligations that are unique from those enforced by other federal agencies in its efforts to protect the safety and security of dietary supplements (although there is a significant amount of overlap between FDA compliance and other aspects of federal healthcare compliance as well). If you are not familiar with the FDA rules and regulations that apply to healthcare providers, you will want to consult with a lawyer who has experience in this area promptly.

3. Audit Your Practice’s or Pharmacy’s Recent Semaglutide Prescriptions

In addition to reviewing your practice’s or pharmacy’s compliance program, you will also want to examine the program’s efficacy. This involves conducting an audit of your practice’s or pharmacy’s recent semaglutide prescriptions. You should gather all relevant documentation—including your Ozempic and Wegovy prescription records and documentation of your prescription dispensing and inventory management history—ensuring you review everything that the FDA’s investigators will review if the agency targets your practice or pharmacy.

4. Conduct a Comprehensive and Unbiased Compliance Assessment

By reviewing documentation that your practice or pharmacy has on-hand, you should be able to conclusively confirm compliance with the FDA’s requirements. If you cannot confirm comprehensive FDA compliance, this means that there is work to be done. Again, if you aren’t sure what it takes to establish, document, and evaluate full FDA compliance, you will want to consult with an experienced federal healthcare compliance lawyer promptly.

5. Review Your Practice’s or Pharmacy’s Marketing Content (if Any)

If your practice or pharmacy has marketed weight loss drugs or services to patients or to the public at large, you should review the content of all marketing materials as well. This includes everything from mailers and signage in your office to podcast comments and posts on social media. Marketing compliance is a key focus area for the FDA. If your practice or pharmacy has made marketing claims that cannot be substantiated, or if it has represented the benefits of semaglutide in a biased manner, this could lead to civil or criminal enforcement action. This is true whether your practice or pharmacy made the claims directly or you engaged a marketing agency that published content with or without your approval.

6. Ensure that the Semaglutide Drugs in Your Inventory Are Not Counterfeit

Drug counterfeiting is a priority enforcement area for the FDA as well. With the rise in popularity of Ozempic and Wegovy, counterfeit semaglutide medications are a very real concern for both patients and providers. To avoid dispensing counterfeit drugs, healthcare practices and pharmacies must follow appropriate protocols and procedures for purchasing and verifying the source of all medications.

7. Do Not Wait for an FDA Investigation to Make Changes

If these efforts uncover compliance deficiencies, or if you are already aware that your practice or pharmacy is not fully complying with the FDA’s requirements, you should not wait for an FDA investigation to make changes. If a provider is aware of compliance deficiencies and fails to address them proactively, this can raise the stakes of an FDA investigation significantly. Conversely, promptly remedying compliance violations upon discovery can help to demonstrate good-faith compliance efforts—and it can go a long way toward resolving an FDA inquiry without civil or criminal penalties.

8. Make Sure You Know What to Do in the Event of an FDA Investigation

Given the risk of facing an investigation related to your practice’s or pharmacy’s semaglutide prescription marketing and management practices, it is important to make sure you know what to do in the event that you are contacted by the FDA. When facing an FDA investigation, early mistakes can prove very costly.

So, what should you do if the FDA contacts you? While there are several steps you need to take when facing an FDA investigation, one of the first—and by far the most important—is to engage experienced defense counsel promptly. As a healthcare provider, you do not want to try to deal with the FDA on your own, especially when facing an investigation related to a priority enforcement area like semaglutide-related compliance.

9. Do Not Overly Cooperate with the FDA

Many healthcare providers assume that the best way to resolve an FDA investigation is by cooperating fully. While cooperation can be an effective tactic in some cases, in others it can be extremely dangerous. Sharing information with the FDA voluntarily can invite additional scrutiny; and, until you know exactly what information you need to share in order to resolve the FDA’s investigation favorably, you need to be cautious about sharing anything with the agency’s investigators.

10. Do Not Focus Solely on FDA Compliance When Assessing Your Practice’s or Pharmacy’s Semaglutide-Related Risks

As we mentioned above, due to the FDA’s current focus on semaglutide weight loss medications, healthcare providers that market, prescribe, and dispense these medications should focus specifically on FDA compliance at this time. However, providers should not focus on FDA compliance to the exclusion of addressing their other compliance obligations.

Marketing, prescribing, and dispensing drugs like Ozempic and Wegovy implicate a multitude of other federal compliance obligations as well. If providers do not dutifully address all aspects of compliance, in addition to facing scrutiny from the FDA, they can also face scrutiny from the Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), Department of Health and Human Services Office of Inspector General (DHHS OIG), Centers for Medicare and Medicaid Services (CMS), and other federal agencies.