Officials said they’re going to ramp up enforcement of federal regulations on the drug ads.
Federal officials on Sept. 9 sent 100 letters to companies telling them to cease misleading advertisements for pharmaceutical products, as President Donald Trump signed a new memorandum saying his administration would “ensure that the current regulatory framework for drug advertising results in fair, balanced, and complete information for American consumers.”
Trump said that officials with the Department of Health and Human Services and the Food and Drug Administration would take action to make sure that direct-to-consumer ads are transparent, accurate, and not misleading.
“Pharmaceutical ads hooked this country on prescription drugs,” Health Secretary Robert F. Kennedy Jr. said in a statement. “We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising. Only radical transparency will break the cycle of overmedicalization that drives America’s chronic disease epidemic.”
FDA regulations require ads to present “a fair balance between information relating to side effects and contraindications and information relating to effectiveness of the drug” and prohibit creating a “misleading impression.”
The government had, in recent years, stopped enforcing regulations that prohibit pharmaceutical ads from creating a “misleading impression” and require them to present a “fair balance of information,” a senior administration official told reporters on a call.
The FDA has increasingly declined to enforce the regulations. While in the past the agency would regularly send more than 100 enforcement letters to companies each year, just one was sent in 2023, and none were sent in 2024, according to the administration.
Regulators sent 100 cease-and-desist letters on Tuesday, as well as thousands of other letters alerting companies that the government would be enforcing the rules. The official declined to identify any of the companies or commit to releasing the letter.
“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,” Dr. Marty Makary, the FDA’s commissioner, said in a statement.
