WASHINGTON (dpa-AFX) - The U.S. Department of Health and Human Services and the Food and Drug Administration have announced sweeping reforms to rein in misleading direct-to-consumer pharmaceutical advertisements. FDA said it is sending thousands of letters warning pharmaceutical companies to remove misleading ads and issuing approximately 100 cease-and-desist letters to companies with deceptive ads.
In addition to enforcing existing law, the FDA is initiating rulemaking to close the 'adequate provision' loophole created in 1997, which drug companies have used to conceal critical safety risks in broadcast and digital ads, fueling inappropriate drug use and eroding public trust.
'Pharmaceutical ads hooked this country on prescription drugs,' Health and Human Services Secretary Robert F. Kennedy, Jr. said. '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.'
Robert Kennedy is acting on the basis of a Presidential Memorandum that Donald Trump signed Tuesday to protect Americans by ensuring direct-to-consumer prescription drug advertisements are providing consumers with full and accurate information.
The Memorandum directs the Secretary of Health and Human Services to ensure transparency and accuracy in direct-to-consumer prescription drug advertisements, including by increasing the amount of information regarding any risks associated with the use of prescription drugs.
It also directs the Commissioner of the Food and Drug Administration to take action to enforce legal requirements that advertisements for prescription drugs be truthful and not misleading.
The FDA said it is concerned patients are not seeing a fair balance of information about drug products. This concern is magnified when serious risks are not clearly presented, or the information is too difficult for seniors to read or hear.
A 2024 review in the Journal of Pharmaceutical Health Services Research revealed that while 100 percent of pharmaceutical social media posts highlight drug benefits, only 33 percent mention potential harms. Moreover, 88 percent of advertisements for top-selling drugs are posted by individuals and organizations that fail to adhere to the FDA fair balance guidelines.
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