The Food and Drug Administration (FDA) is launching a crackdown on “misleading” pharmaceutical advertisements.
The agency announced on Tuesday that it is issuing thousands of warning letters and roughly 100 cease-and-desist orders to drug companies. “You are hereby directed to remove any noncompliant advertising and bring all promotional communications into compliance,” the FDA warned in its letters.
“This notice also serves to demand compliance with the [Federal Food, Drug, and Cosmetic] Act and FDA implementing regulations and requires companies to remove any and all DTC (direct-to-consumer) prescription drug advertising that violates the law,” the letters said.
The FDA explained that current law mandates drug ads to “present a fair balance between a product’s risks and benefits; avoid exaggerating benefits; not create a misleading overall impression; properly disclose financial relationships; and include information regarding major side effects and contraindications.” The agency said these standards were not properly enforced during the previous administration but will now be “aggressively” enforced.
As part of the effort, the FDA said it will close the “adequate provision” loophole, which companies have used to conceal safety risks in broadcast and digital advertising, fueling misuse of medications and “eroding public trust.” The crackdown will apply not only to television commercials but also to promotional content from social media influencers.
A 2024 review in the Journal of Pharmaceutical Health Services Research found that all pharmaceutical social media posts examined highlighted benefits, but only one-third mentioned potential harms. It also found that 88 percent of ads for top-selling drugs were shared by individuals or organizations that failed to meet the FDA’s fair balance requirements.
“For far too long, the FDA has permitted misleading drug advertisements, distorting the doctor-patient relationship and creating increased demand for medications regardless of clinical appropriateness,” FDA Commissioner Marty Makary said in a statement. “Drug companies spend up to 25% of their budget on advertising. Those billions of dollars would be better spent on lowering drug prices for everyday Americans.”
