The president signed an executive action Tuesday to crack down on online pharmacies that are allegedly flouting Food and Drug Administration (FDA) regulations that require them to list the potential harms and side effects of any drug they advertise.
The memo directs the FDA and HHS Secretary Robert F. Kennedy Jr. to “ensure transparency and accuracy in direct-to-consumer prescription drug advertising,” including by disclosing risks.
The Trump administration is sending out about 100 cease-and-desist letters to online pharmacies and companies that the administration says are skirting FDA drug advertisement rules, as well as “thousands” of warning letters, a senior administration official told reporters during a phone call ahead of the signing. The official spoke on the condition of anonymity.
FDA regulations say pharmaceutical ads can’t relay misleading information, and must list the drawbacks of a given medication, but enforcement of those rules has become extremely lax, the official said. While in years past, the FDA may have sent out 100 enforcement letters, in 2023 and 2024, only one was sent, the senior administration official said, and physicians are frustrated.
One ad that “caught the eye of U.S. senators” who wrote a letter to the FDA was a Hims &Hers ad that ran during the Super Bowl, the official said. The advertisement from the telehealth startup featured its version of a weight loss drug, but failed to include safety warnings. Before the ad aired, Democratic Sen. Dick Durbin of Illinois and Republican Sen. Roger Marshall of Kansas expressed concerns about FDA compliance, and urged the agency to investigate. The company said at the time it had complied with the law.
But the administration is also concerned about social media influencers who are advertising products, often without listing potential harmful side effects. The official said a recent study showed only one-third of such social media influencers posted the potential harms or side effects of the products they advertised. The FDA is looking to put pressure on them and the drug companies for which they advertise.
