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President Donald Trump signed an executive order late Tuesday to target direct-to-consumer pharma advertising, the furthest escalation in the administration’s ongoing efforts to clamp down on medical marketing.
As part of the executive action, Trump directed the Department of Health and Human Services and the Food and Drug Administration to “rein in misleading” DTC pharma ads on TV and social media.
How the administration intends to achieve this, per a press release, is to initiate a rulemaking process designed to close the “adequate provision” loophole introduced in 1997.
The White House’s strategy involves issuing warning letters and potential cease-and-desist orders to drugmakers rather than imposing a wholesale prohibition on drug ads.
In a statement, HHS Secretary Robert F. Kennedy Jr. said pharmaceutical ads have “hooked this country on prescription drugs” and added that the administration intends to take action against this form of medical marketing.
“We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising,” he stated. “Only radical transparency will break the cycle of overmedicalization that drives America’s chronic disease epidemic.”
FDA Commissioner Dr. Marty Makary issued a post on X to further outline the administration’s goals with this proposal.
While newsmaking, the administration’s approach to drug advertising appears to be more measured than initially feared, as drugmakers do not yet face an immediate ban on DTC advertising.
James Potter, executive director of the Coalition for Healthcare Communications, said that while the announcements are making mainstream headlines, it isn’t exactly Mayday for the industry.
Potter said The White House’s directors are a “far cry” from earlier proposals floated by both Trump and Kennedy as presidential candidates — namely the idea of an executive order to immediately ban all DTC prescription drug advertising.
He said that until drugmakers receive specific communications from the FDA in the form of a cease-and-desist letter, these declarations should be considered more akin to “bluster” than concrete policymaking.
Considering the Trump administration’s relative lack of discipline when it comes to rulemaking, he said pharma companies and medical marketing agencies should proceed with business as usual until something more substantive comes to the fore.
“We’re encouraging our members and their clients to stay the course and not capitulate or pull back on ad buys by being leveraged by threats from the administration,” he said.
Even if the Trump administration finalized a rule to roll back the FDA statute from 1997, he said this would likely face significant legal challenges based on First Amendment grounds.
Additionally, he noted that the FDA’s enforcement capacity is limited due to a reduced staff, which may impact the implementation of these proposed actions.
This is a developing story that will be updated as more information becomes available.
Related: What to know about Trump’s proposed crackdown on DTC pharma ads