As the semaglutide industry increases in size and scope, supply chain participants must take steps to protect their businesses from regulatory action. The first and most important step is the implementation of a well-designed and effective compliance program. In the event of regulatory scrutiny, a compliance program will be invaluable.

Semaglutide Risks are High

Although healthcare is a highly regulated industry in general, the risks associated with semaglutide are higher than the norm.

First, weight loss drugs are the subject of intense public attention and demand. Anytime the public is focused on a particular trend, you can be sure that regulators will follow.

Second, certain of the weight loss drugs involve sterility requirements. This patient safety consideration increases risk overall.

Third, the industry is diffuse, and consolidation has not yet occurred. The vast number of participants involved attracts regulatory attention.

Finally, Ozempic's manufacturer, Novo Nordisk, has filed numerous lawsuits, and is engaged in an aggressive campaign to protect its margins. Indeed, it is likely that Novo is paying millions of dollars to lobbyists to this end.

Semaglutide Regulations Vary

Numerous agencies, both federal and state, are involved in semaglutide oversight.

First and foremost, state pharmacy and medical boards are responsible for enacting administrative laws regulating the dispensing of drugs, such as semaglutide. Numerous state boards have promulgated semaglutide-specific regulations and rules.

Second, the Food & Drug Administration (FDA) is a federal agency that regulates "human drugs," which are defined to include FDA-approved drugs as well as Active Pharmaceutical Ingredients (APIs). FDA-approved weight loss drugs include Ozempic and Wegovy, but the FDA also separately regulates the semaglutide API.

Finally, numerous other agencies, including Consumer Protection and even Customs & Border Protection in the case of imported ingredients, may play a role in the regulation of semaglutide and other weight loss drugs.

Implement a Semaglutide Compliance Program

The goal of an effective compliance program is to prevent and detect potential noncompliance in business operations. Depending on the nature of those business operations, compliance programs should be tailored accordingly.

For example, if your business is engaged in the importation of the semaglutide API, a compliance program will need to incorporate FDA registration and U.S. Customs rules and regulations. On the other hand, if your business is engaged in the distribution of weight-loss drugs, you will need to be mindful of state licensing and registration requirements. Finally, if your business is engaged in patient-facing operations, whether that be sales to nutrition or weight-loss clinics, or administration of injections, any compliance program must be tailored accordingly to address those risks.

An effective compliance program, however, must also include due diligence of counterparties. In other words, if you are purchasing semaglutide from a distributor, your compliance program should be designed to ensure that your counterparty is meeting important regulatory requirements. For example, is the distributor appropriately licensed and registered in the state in which it does business?

Finally, an efffective semaglutide compliance program should address drug supply chain and procurement requirements. For example, did the distributor obtain the API from a FDA-registered facility, whether located in the United States or overseas? Have there been any prior enforcement actions or FDA inspections involving the facility? Have all Certificates of Analysis been received and maintained?

HLA's Semaglutide Compliance Expertise

Health Law Alliance is an industry thought-leader in the semaglutide industry. We have published numerous articles and routinely advice semaglutide businesses at all levels of the supply chain, from importation, distribution, compounding and dispensing. In particular, the firm's founding partner, Anthony Mahajan, previously served as the Chief Compliance Officer for UnitedHealth, one of the largest healthcare companies in the world, and our attorneys are former regulators with extensive industry experience.

‍Contact us today if you need assistance implementing a semaglutide compliance program.