Dr. Martin Makary, a Johns Hopkins surgeon and President Donald Trump’s nominee for FDA commissioner, recently faced his first Senate hearing. Unlike some of Trump’s more controversial picks, Makary has a medical background and is considered a more conventional choice for the position. During the hearing, lawmakers questioned Makary about his political views and how he plans to address challenges at the FDA.
One of the immediate tests awaiting Makary at the FDA is the issue of a depleted workforce. Last month, the Trump administration made significant cuts to the federal workforce, including at health agencies. While some staff have been rehired, there are concerns about how the FDA will function with a reduced workforce. Delays in the review process could be on the horizon as the new leadership settles in.
Makary has stated that he will assess the workforce and ensure scientists have the resources they need to do their jobs. However, more agency cuts are still a possibility, which has raised concerns about the impact on the drug review process. Despite these challenges, it is unlikely that the administration would make changes that significantly disrupt the review process.
Another key issue facing Makary is the influence of Robert F. Kennedy Jr., who was recently confirmed as secretary of HHS. Kennedy’s views on vaccines could impact how health agencies approach vaccination policies. Senators questioned Makary about his commitment to following scientific evidence, particularly in the context of vaccine safety and efficacy.
The FDA is also currently engaged in a battle with compound pharmacies and pharmaceutical companies over GLP-1s, a class of medications used for weight loss and diabetes. The agency recently removed semaglutide, the active ingredient in Novo Nordisk’s drugs, from its shortage list. Compounded pharmacies have entered the GLP-1 market during shortages, raising concerns about the quality and safety of these products.
As Makary prepares to take on the role of FDA commissioner, he will need to navigate these challenges and ensure that the agency continues to fulfill its regulatory responsibilities effectively. His responses to questions during the Senate hearing suggest that he is committed to upholding scientific integrity and addressing key issues facing the FDA. The recent decision by the FDA to remove semaglutide from the drug shortage list has stirred up controversy within the pharmaceutical industry. This move has set a countdown for companies selling compounded versions of the drug to cease their operations, leading to legal battles and concerns about potential conflicts of interest.
After tirzepatide, a key component in Eli Lilly’s GLP-1 drugs, was also taken off the shortage list, compounders quickly took legal action against the FDA. Last week, these same compounders filed a lawsuit following the removal of semaglutide from the list, further escalating the tensions between the regulatory agency and the companies affected.
Industry experts like Rosen have expressed surprise at the timing of semaglutide’s removal from the shortage list, especially considering the current vacancies in leadership roles at the FDA and ongoing legal disputes. With no commissioner in place and an acting director for the Center for Drug Evaluation and Research, the decision to delist semaglutide raises questions about the agency’s decision-making process.
Moreover, concerns have been raised about potential conflicts of interest involving Dr. Makary, who previously held positions in companies offering compounded GLP-1 medications. Although Dr. Makary has since resigned from these roles, his past affiliations could influence his approach to handling the situation, according to Rosen.
Despite these controversies, Rosen believes that the FDA would not have taken action to remove semaglutide from the shortage list if they were not confident in their decision. He anticipates that Dr. Makary will either adhere to the law or recuse himself from the decision-making process due to his previous involvement in the pharmaceutical industry.
As the pharmaceutical industry continues to navigate the implications of the FDA’s actions, stakeholders are closely monitoring the developments and potential outcomes of the legal disputes. The removal of semaglutide from the shortage list marks a significant turning point for companies selling compounded versions of the drug, signaling the need for compliance with regulatory guidelines and potential changes in business operations.
