Core Points - President Trump has directed the FDA to enhance transparency and accuracy in direct-to-consumer advertising for prescription drugs [1][4] - The FDA will introduce a new federal rule to remove the 1997 Adequate Provision exception, requiring more comprehensive risk information in ads [14] - The FDA plans to increase enforcement of existing regulations, having sent 100 compliance letters to drug companies on September 9, 2023 [15][16] Industry Impact - Direct-to-consumer advertising for prescription drugs has grown to a $13.8 billion industry as of 2023, with significant spending by major companies [7] - The top advertiser, AbbVie, spent nearly $1.4 billion in 2024 to promote specific medications [7] - The FDA's increased oversight will extend to social media platforms, targeting influencer partnerships and AI-generated content [17] Regulatory Changes - The FDA's enforcement actions will include addressing "false and misleading advertising" and misbranding of drugs, with potential penalties including recalls and civil charges [16] - The FDA's previous enforcement letters numbered around 130 annually in the late 1990s, but only three were sent in 2023, indicating a significant reduction in enforcement activity [15] Broader Administration Actions - The executive memorandum is part of a broader strategy by the Trump administration to reform the pharmaceutical industry, including pricing policies and the role of pharmacy benefit managers [18][19] - The administration's focus on drug pricing aims to ensure U.S. consumers pay the lowest available prices for medications, addressing the disparity in costs compared to other countries [19]
Trump's Crackdown On Prescription Drug Ads: What To Know