Novo Nordisk, the manufacturer of FDA-approved semaglutide drugs Wegovy, Ozempic and Rybelsus, has embarked upon an illegitimate public relations campaign to stop the compounding of semaglutide despite overwhelming patient need for these products. Most recently, Novo filed a series of lawsuits against Florida compounding pharmacies. Don’t be intimidated: the lawsuits are baseless.

Semaglutide Background

We have written previously about laws applicable to the compounding of products containing semaglutide, a glucagon-like peptide (GLP-1) receptor agonist, here.

Given the market short-supply of these products, many pharmacies have turned to compounding to meet overwhelming demand from diabetics and/or overweight patients.

Of note, obesity in this country has sky-rocketed in recent years, and is linked to many comorbidities, such as heart disease, stroke and cancer, that place additional strain on our health system and impair patients’ quality of life.

Novo Nordisk’s Attempts to Limit Semaglutide

For obvious reasons, Novo Nordisk would like to limit the market availability of semaglutide drugs to its FDA-approved brands. Further to that agenda, Novo has attempted previously to raise patient safety concerns, including by claiming that a purportedly “counterfeit” Ozempic pen was “found” at an unidentified “retail” pharmacy.

The manufacturer also filed lawsuits in June 2023 against medical spas and weight-loss clinics relating to false advertising, i.e., the defendants implied that they were selling the branded products.

Most recently, on July 7, 2023, Novo filed additional lawsuits against compounding pharmacies for violating Florida’s Deceptive and Unfair Trade Practices Act, which prohibits “unfair” acts or practices.

Novo’s Efforts to Limit Semaglutide are Frivolous

Put bluntly, Novo’s latest lawsuits are utterly frivolous and a sham designed to intimidate compounders. For example, Novo alleges that the defendants are manufacturing “Unapproved New Drugs” containing semaglutide.

Novo complains that “[r]ather than invest the time and resources necessary to research, develop, and test its products in order to ensure that they are safe and effective and to obtain regulatory approval to market them, Defendant is simply creating, marketing, selling, and distributing Unapproved New Drugs throughout Florida and other states.”

Novo claims that  the defendants’ sale of semaglutide compounds violates the law because there is “no approved New Drug Application or Abbreviated New Drug Application for Defendant’s Unapproved New Drugs.”

Semaglutide Compounding is Clearly Permissible

Congress amended the FD&C Act by adding Sections 503A and 503B to specifically authorize the compounding of human drugs as an exception to Section 505’s NDA and ANDA registration requirements. Nonetheless, Novo complains that, “[i]gnoring drug-approval requirements provides Defendant an unfair competitive advantage over pharmaceutical manufacturers like Novo Nordisk.”

In authorizing compounding, however, Congress already considered, and directly rejected, the same arguments made by Novo in its lawsuit. Indeed, the plain language of Section 503A provides: “Sections 501(a)(2)(B), 502(f)(1), and 505 shall not apply to a drug product if the drug product is compounded for an identified individual patient based on the unsolicited receipt of a valid prescription order.” Likewise, Section 503B of the FD&C Act, applicable to outsourcing facilities, mirrors Section 503A’s exceptions.

Moreover, the FDA has expressly authorized Section 503B semaglutide compounding by listing the drug on the shortage list, under Section 506E of the FD&C Act, currently in effect.

In sum, Novo’s arguments are all based on the lack of FDA approval for compounds, a completely irrelevant point. For example, one would expect Novo to allege concerns over the use of semaglutide salts instead of semaglutide base. It is just a guess, but we suspect that Novo did not go down that road because Novo may be using sodium in its manufacturing process as a counter-ion to balance PH levels.

Semaglutide Compounders Should Not be Intimidated

Let’s call the lawsuits for what they are: concocted headline-grabs designed to intimidate the compounding industry with no actual substance behind them. Here, at the Health Law Alliance, we have worked for the biggest players in healthcare and know the tactics they employ.

Our experienced healthcare defense attorneys regularly assist pharmacies and physician compounders to understand their obligations, including with respect to all levels of the semaglutide supply chain.

Our firm’s mission is simple: use unmatched experience and insight to defend our clients against insurance conglomerates, the federal government, and state agencies. We used to work for them. Now let us fight for you. Contact us today for a consultation. We can help.