By Ahmed AbouleneinWASHINGTON (Reuters) – Outgoing U.S. Food and Drug Administration Commissioner Robert Califf raised concerns on Thursday about the adequacy of current laws and regulations in protecting Americans from the dangers of compounded versions of popular weight loss drugs, particularly those purchased online.
Califf emphasized that the issue of these drugs proliferating would be less severe if the prices of the original medications were more affordable. Speaking at a media roundtable, he highlighted the growing unease regarding the internet compounding industry. “I’m very worried about the internet compounding industry. Some of it, I’m sure, is very high quality, but it’s very hard, if you are ordering things on the internet, to know exactly what you’re getting,” Califf remarked as he prepares to step down from his role once incoming President-elect Donald Trump assumes office.
The soaring costs of weight loss drugs from companies like Novo Nordisk and Eli Lilly, which can exceed $1,000 for a month’s supply, have driven consumers towards cheaper compounded alternatives priced at a few hundred dollars. Califf stressed the need for enhanced support for the FDA to address these challenges.
Califf’s concerns stand in contrast to the views expressed by Robert F. Kennedy Jr., Trump’s nominee for health secretary, who has been critical of the FDA’s oversight role in nutrition labeling on food products. Kennedy Jr. has advocated for significant changes within the agency, asserting that the department responsible for food labels needs to be overhauled due to its perceived failure in safeguarding Americans.
In response to Kennedy Jr.’s stance, Califf cautioned against diverting resources away from critical areas within the FDA, particularly the sector overseeing food regulation. “Look at the food side; it’s massively underfunded, and if you’re also saying you want to radically change the food system, that will be a problem,” Califf cautioned.
As the debate over drug safety and regulatory oversight continues, the FDA faces increasing scrutiny over its ability to ensure the protection and well-being of the American public. Califf’s departure, coupled with the impending shift in leadership, underscores the evolving landscape of healthcare regulation and the imperative for a robust and responsive regulatory framework to address emerging challenges in the pharmaceutical industry.
(Reporting by Ahmed Aboulenein; Editing by Aurora Ellis)
