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The Trump administration is targeting “misleading drug advertisements” by initiating rule making to close a 1997 loophole that enables drug advertisers to conceal safety risks in broadcast and digital ads.
The Department of Health and Human Services (HHS) and the Federal Drug Administration (FDA) sent thousands of warning letters across the pharmaceutical industry on Tuesday. Sources familiar with the letter told Fox that companies who practice widespread advertising like Hims/Hers are among those receiving the notice.
Fox News Digital also obtained a copy of a letter sent to a pharmaceutical company, which outlines concerns that “patients are not seeing a fair balance of the information regarding a drug product” and directing the company to “remove any noncompliant advertising and bring all promotional communications into compliance.”
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“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, M.D., M.P.H told Fox News Digital 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,” Makary added.
The letters to various companies are being sent out over the course of Tuesday afternoon, and it is unclear whether any companies have had the opportunity to respond.
Fox News Digital reached out to Hims/Hers but did not receive a response.
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The notice sent by the two health-related agencies also cites a 2024 review in the Journal of Pharmaceutical Health Services Research which showed that while every pharmaceutical social media post highlights drug benefits, only 33% of these companies mention potential harms.
The Federal Food, Drug, and Cosmetic Act (FDCA), a law dating back to 1938 and signed into law by President Franklin D. Roosevelt, empowers the FDA to enact appropriate regulations for pharmaceutical advertising.
Social media advertisements also apply to the FDCA and regulations set forth by the FDCA.
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“Patients deserve the truth about the medicines they’re prescribed,” said HHS Secretary Robert F. Kennedy, Jr. said in a statement to Fox News Digital. “For nearly three decades, drug companies have gamed the system to mislead families while pocketing billions.
“Those days are over,” Kennedy continued. “We are restoring honesty and accountability in drug advertising to protect patients and rebuild public trust.”
Per FDA regulations, a written warning letter, like the ones sent by the agency on Tuesday, is the first step in reprimanding drug companies and is one of the FDA’s most commonly used methods of enforcement.
Preston Mizell is a writer with Fox News Digital covering breaking news. Story tips can be sent to [email protected] and on X @MizellPreston
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