A new presidential memorandum directs the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) to strengthen regulation of direct-to-consumer (DTC) prescription drug advertising. The memo stops short of directing a full ban on DTC advertising, instead ordering the agencies to take action to improve the transparency and accuracy of drug advertising.
FDA has already begun implementing the memo, outlining regulatory and enforcement actions it intends to take against manufacturers. FDA announced it is beginning rulemaking to remove a loophole that allowed manufacturers to omit certain safety and risk information in DTC advertising by directing patients to alternate sources such as websites and toll-free numbers. The agency has also begun sending numerous warning letters to pharmaceutical manufacturers regarding misleading or incomplete DTC advertising.
ASHP has long advocated for a ban on DTC advertising due to concerns that it increases inappropriate prescribing and healthcare costs without improving patient outcomes. ASHP policy 1119 reads, “To advocate that Congress ban direct-to-consumer advertising for prescription drugs and medication-containing devices.” DTC advertising can be misleading for patients, overemphasizing drug benefits while downplaying potential adverse effects and other risks.
“Enforcing limits on DTC advertising for medications is a critical step to reduce unnecessary risks and costs for patients,” said Tom Kraus, ASHP vice president of government relations. “We continue to advocate for a full ban on DTC advertising, particularly as patients are bombarded with ads not only through television, but a variety of other mediums, including social media.”
ASHP will update members as FDA and HHS continue to implement the memo’s directives.
