The U.S. Food and Drug Administration (FDA) announced in October 2024 that the shortage of the diabetes medication Ozempic and its counterpart Wegovy has officially ended. This announcement comes on the heels of several months of increased demand for these medications, which are both made with the same active ingredient semaglutide. In this regard, the announcement provides relief to millions of patients. It also raises alarm over the safety and regulation of compounded versions of these drugs, which have gained heightened popularity during the shortage.
Last week, the FDA formally rescinded the shortage status. As a result, manufacturers are able to create these therapeutics without the limitations seen during previous supply crises. The agency has long-standing safety concerns regarding compounded semaglutide. This has the same active ingredient as Ozempic and Wegovy, but it is not subject to the same careful testing and approval process.
Compounded Semaglutide and Safety Concerns
Compounded medications, including versions of Ozempic and Wegovy, have become increasingly prevalent in the U.S., particularly as patients sought alternatives during the shortage. State-licensed pharmacies and outsourcing facilities have been allowed to produce these compounded versions in bulk to address demand. The FDA has already received more than 455 adverse event reports with compounded semaglutide, raising red flags of severe safety concerns.
“Simply, compounded drugs are not FDA-approved, and safety is not guaranteed,” – Kim
While compounded medications can offer timely access to desperately needed treatments, they pose serious risks. The FDA does not review or approve the safety or effectiveness or manufacturing quality of these compounds before they are made available to consumers.
This came at a very bad time for many patients. Some people may turn to compounding pharmacies that are not subject to FDA oversight. This decision will only increase the risk to their health in the process.
“Practically, these patients will turn to shady compounding pharmacies who will defy the FDA, putting themselves more at risk, as more trustworthy pharmacies comply with the FDA,” – Carter-Johnson
Regulatory Developments and Timelines
The FDA has listened to the long-standing concerns regarding compounded semaglutide. Therefore, it will postpone implementation of its prohibition on these products until further order. The order prohibits state-licensed pharmacies from compounding semaglutide after April 22, 2024. In the meantime, outsourcing facilities are allowed to continue operating under current law until May 22, 2024.
The FDA has been gracious enough to delay enforcement for us. That will facilitate a smoother transition for the market as it adapts to the end of the shortage. This spiraling pattern of delay gives the district court lots of time to rule upon legal challenges. In particular, it applies to the practice of regulating compounded medications.
“OFA has several legal theories for this argument, but they all center around the allegation that the FDA relied only on data from the branded drug companies rather than examining other data from consumers or the compounding industry,” – Carter-Johnson
Patients across the country are still trying to gain access to compounded medications. Estimates indicate that nearly 2 million American patients have received treatment with compounded versions of semaglutide. During the 2023-2024 legislative session, between November 2023 and November 2024.
The Market Dynamics for Semaglutide
The FDA recently removed the shortage designation for Ozempic and Wegovy. That’s a huge change and one that’s clearly altering the U.S. market landscape for semaglutide. With these branded formulations, the companies are protected by patents, which let the pharmaceutical companies continue to limit competition from generics and keep prices high. This dynamic has raised concerns about patient access to necessary medications, particularly for those who may not afford expensive brand-name options.
“I wish patients had greater access to these medications, but we cannot guarantee the safety of compounded medications,” – Kim
Compounded GLP-1 drugs such as Ozempic and Wegovy are hot commodities these days. Weight-loss pills are big business. This trend reflects a growing and much-needed demand for effective weight-loss solutions. As awareness of potential risks increases, patients may need to navigate a complex landscape of options while remaining cautious about their choices.
Leave a Reply