FDA cracks down on prescription drug ads but lacks staff

WASHINGTON – In an unprecedented move, federal regulators published about 100 warning letters sent to pharmaceutical companies and health care providers, ordering them to stop or alter ads or other promotions the government considered misleading.

The letters went to major drugmakers like Novartis and Eli Lilly, and to telehealth firms like Hims & Hers, shortly after the Trump administration announced the advertising crackdown. But experts questioned whether the Food and Drug Administration has the resources to prosecute this aggressive campaign after laying off many of the experienced staff who would lead the effort.

“What happens when those 100 responses come in, and how is FDA going to prioritize its review of those?” said Joshua Oyster, a partner at Ropes & Gray. “How is the FDA going to prioritize follow-up actions, if any, in response to those responses?”