FDA Semaglutide Investigation Defense

FDA Compliance Lawyers for Healthcare Entities Nationwide

With the Growing Popularity of Ozempic and Other Weight Loss Medications, We Are Seeing an Increase in FDA Semaglutide Investigations

In early 2023, the U.S. Food and Drug Administration (FDA) approved semaglutide for treating childhood obesity starting at age 12. This label update also removed a previous limitation which stated that semaglutide should not be used as an initial therapy for patients with type 2 diabetes. Shortly thereafter, Ozempic, a brand-name semaglutide began making national headlines—and this in turn garnered new scrutiny from the FDA.

As a result, if you own or operate a healthcare practice or pharmacy and you are facing an FDA investigation related to your prescription or dispensing of semaglutide, you are not alone. The FDA is actively targeting physicians, pharmacists, and other healthcare providers in semaglutide investigations nationwide. At Oberheiden P.C., we have extensive experience representing healthcare providers in FDA investigations, and we can use our experience to help protect you and your practice.

Semaglutide and the FDA: The History of Prescription Weight Management Drugs in the U.S.

The FDA first approved semaglutide for prescription weight loss management in 2017. Novo Nordisk obtained FDA approval for its brand-name drug Wegovy in a disposable single-use pen formulation and format. Wegovy remains approved for use in the U.S. today; and, until relatively recently, it has largely flown under the radar. In 2021, the FDA issued an additional approval for Wegovy, “for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), for use in addition to a reduced calorie diet and increased physical activity.”

Novo Nordisk also obtained FDA approval for Ozempic in 2017. Ozempic is indicated for use as, “an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus,” and “to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.”

As noted above, in early 2023 the FDA further expanded the approved prescription use of semaglutide in the United States. This seems to have spurred renewed interest in drugs such as Wegovy and Ozempic, particularly within the popular media. This media coverage has driven an increase in demand; and, as a result, many physicians and pharmacists are prescribing semaglutide in record numbers.

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Increased Demand for Semaglutide Leads to Increase in FDA Scrutiny

The increased demand for semaglutide has also triggered an increase in FDA scrutiny. Any time a drug gains popularity, there is a risk for fraud—especially when the drug is only available by prescription. The FDA shares responsibility with the U.S. Drug Enforcement Administration (DEA) for enforcing prescription drug compliance, with the FDA focusing its enforcement efforts on marketing claims, counterfeiting, adverse event reporting, and other areas of FDA compliance.

While most healthcare providers are generally familiar with the compliance obligations enforced by the DEA and federal healthcare agencies such as the Centers for Medicare and Medicaid Services (CMS) and U.S. Department of Health and Human Services (DHHS), in our experience far fewer are familiar with the compliance obligations enforced by the FDA. But, facing an FDA investigation is just as risky—and just as much of a concern—as facing an investigation from one of these other agencies. As a result, if the FDA is looking into your business’s or practice’s compliance efforts related to semaglutide, it is extremely important that you speak with an experienced healthcare fraud defense lawyer as soon as possible.

What Physicians, Pharmacists, and Other Providers Need to Know About FDA Semaglutide Investigations

If the FDA is investigating your business or practice in relation to the prescription or distribution of Ozempic, Wegovy, or other semaglutide medications, there is a lot you need to know. Here are some key preliminary considerations from the lawyers on our healthcare fraud defense team:

1. FDA Investigations Can Have Civil or Criminal Consequences

When targeting healthcare providers in relation to the marketing, prescription, and dispensing of semaglutide medications such as Ozempic and Wegovy, the FDA can pursue either civil or criminal penalties. While many FDA enforcement actions are civil in nature, the FDA has an Office of Criminal Investigations that works alongside the U.S. Department of Justice (DOJ) to pursue criminal charges when warranted. When the FDA uncovers a large volume of fraud in relation to a particular medication or medical device, it will often pursue criminal charges in an effort to send a clear message that ongoing fraudulent practices will not be tolerated.

2. The FDA Can (and Does) Investigate a Broad Range of Offenses

When facing an FDA investigation in relation to the marketing, prescription, or dispensing of semaglutide, it is important to quickly identify the specific allegation (or allegations) at issue. The FDA investigates a broad range of offenses, from unsubstantiated claims about weight loss results to providing (and filling) semaglutide prescriptions that are not medically necessary. To ensure that they are defending against the right charges during the FDA’s investigation, providers must promptly engage legal counsel to intervene and determine the investigation’s trigger, focus, and scope.

3. Being Able to Demonstrate Compliance is Critical for Avoiding Unnecessary Consequences

Regardless of the specific allegations against you or your practice, defending against an FDA semaglutide investigation successfully requires clear documentation of compliance. When facing FDA scrutiny, you need to be able to convince investigators that you have done everything necessary to remain compliant with the law. If you can demonstrate good-faith compliance (and demonstrate that any errors were due to factors beyond your control), this can facilitate a swift and favorable resolution. However, if you cannot demonstrate compliance, this is a major red flag that can increase the risks of the FDA’s investigation significantly.

4. A Proactive Approach is Generally Best (Though Being Overly Cooperative Can Be Costly)

To avoid unnecessary consequences during an FDA semaglutide investigation, taking a proactive approach to demonstrating compliance (or pursuing an alternative defense strategy) is generally best. With that said, practitioners and business owners must be very careful to avoid being overly cooperative. Sharing information with the FDA unnecessarily can be dangerous—and in some cases it is a mistake that cannot be overcome.

5. Practices and Practitioners Targeted By the FDA Need Experienced Legal Representation

To execute a proactive defense during an FDA semaglutide investigation, targeted practices and practitioners need experienced legal representation. If you have been contacted by the FDA (or if you are concerned about being contacted by the FDA), you should speak with a federal healthcare fraud defense lawyer as soon as possible. At Oberheiden P.C., we defend physicians, pharmacists, and other healthcare providers in FDA matters nationwide; and, if you are facing scrutiny from the FDA, our lawyers can get to work defending against the FDA’s semaglutide investigation immediately.

FAQs: Defending Against an FDA Semaglutide Investigation

Speak with a Federal Healthcare Fraud Defense Lawyer at Oberheiden P.C.

Do you need to speak with a lawyer about an FDA semaglutide investigation? If so, we encourage you to contact us for more information. To schedule an appointment with a senior lawyer at Oberheiden P.C. call 888-680-1745 or tell us how we can help online today.