Compounded Obesity Drugs, Semaglutide and Tirzepatide: Navigating Supply Shortages, Safety Risks, and Industry Interests
The FDA is currently facing a dilemma regarding the compounding of new obesity medications, specifically semaglutide and tirzepatide. These medications, which have garnered significant attention for their potential in managing obesity, are in short supply, creating a complex situation. The President-Elect has nominated a new candidate to lead the FDA who has direct connections to the ongoing debate. Marty Makary, a prominent surgeon and professor at Johns Hopkins School of Medicine, also serves as Chief Medical Officer for Sesame, a telehealth company offering weight loss services.
Sesame’s weight loss program, which costs $249 per month, includes medication as part of the package. The program promotes “high-quality, pre-measured compounded semaglutide at cost for eligible patients,” which bypasses the high prices charged by the manufacturers of the original semaglutide and tirzepatide, Novo Nordisk and Eli Lilly. Given the widespread interest in obesity treatments, compounded versions of these medications have emerged as an alternative to the high-priced branded drugs.
A Gray Area in Supply and Demand
In case you’re not familiar with the situation, compounded medications are a contentious issue for the FDA. Compounding, which involves pharmacies creating custom medications based on a doctor’s prescription, undermines the monopoly held by companies like Novo Nordisk and Eli Lilly, whose high-priced drugs are protected by patents. The shortage of these medications has created an opening for compounding pharmacies to step in and offer the drugs at significantly lower prices, raising the stakes in the debate.
However, the FDA’s stance on this issue is complicated. The agency has acknowledged a shortage of semaglutide and tirzepatide, but when it attempted to declare the shortage over, compounding pharmacies filed lawsuits, claiming the FDA’s decision was unlawful and arbitrary. In response, the FDA walked back its original ruling and has been cautious in determining how to proceed. In the meantime, both Novo Nordisk and Eli Lilly are suing businesses that are producing and distributing compounded versions of their medications. Both companies, as well as the FDA, are warning that compounded medications may carry risks.
Doctors Divided on the Issue
Within the medical community, there is a division of opinion on compounded obesity drugs. Some physicians are steadfast in their refusal to recommend compounded versions, citing safety concerns. Others argue that for some patients, compounded drugs may be the only option, especially when access to the original medications is limited or unaffordable.
Marty Makary’s Dual Role
As Chief Medical Officer for a company involved in the sale of compounded semaglutide, Marty Makary’s position is undeniably conflicted. If confirmed as the new FDA Commissioner, it is expected that Makary will step down from his role at Sesame, but his prior involvement in the issue is likely to influence his actions in the future. The nomination has been met with cautiously positive reactions from many, including Jerome Adams, former U.S. Surgeon General, who described him as one of the least controversial health picks from the President-Elect’s administration. On the other hand, biotech investors have expressed relief at his nomination, suggesting that he is viewed as a more stable choice compared to others.
An additional layer of complexity lies in the fact that Robert F. Kennedy Jr., a vocal critic of semaglutide, would oversee Makary at the FDA if both are confirmed. This adds an unpredictable dynamic to the situation, making it likely that the issue of compounded semaglutide will remain a point of contention for the FDA under this new leadership.
Commentary by YourDailyFit columnist Alice Winters:
The ongoing debate over compounded semaglutide and tirzepatide reflects broader tensions in the healthcare and pharmaceutical industries. While the FDA’s struggle to navigate this issue is understandable, it also underscores the inherent flaws in the U.S. healthcare system—particularly with regard to pricing, access, and the monopolistic practices of big pharmaceutical companies. Compounding pharmacies are capitalizing on a legitimate gap in the market: the inability of companies like Novo Nordisk and Eli Lilly to meet demand at accessible prices. This situation highlights the urgent need for reforms in drug pricing and supply chain management.
Marty Makary’s dual role, as a nominee for FDA Commissioner and his ties to a company selling compounded semaglutide, adds a layer of complexity to an already contentious issue. It is crucial for regulatory bodies to maintain a clear and impartial stance, particularly when the potential for conflicts of interest arises. Makary’s prior involvement in the sale of compounded drugs does not necessarily disqualify him from the position, but it does cast a long shadow over his future decisions, especially in matters of drug safety and accessibility.
As for the patients caught in the middle of this dilemma, the situation is fraught with ambiguity. On one hand, compounded medications may offer a more affordable alternative to the branded versions, but the risks associated with these alternatives are not insignificant. Doctors are understandably divided, with some prioritizing safety and others advocating for patient autonomy, especially for those who cannot access the original drugs due to financial or logistical barriers.
In the end, the compounded semaglutide controversy may be symptomatic of larger issues within the pharmaceutical industry. It’s clear that the current system, which relies on high prices for innovative treatments, needs reevaluation. If compounded versions of these drugs can be produced safely, they may represent an important option for patients. However, regulators must tread carefully to ensure that the benefits outweigh the potential risks, both in terms of patient safety and market dynamics.
