Drugs

Makary Details DTC Enforcement Crackdown on Podcast

FDA commissioner Marty Makary recently addressed the agency’s significant shift in enforcement policy directed at direct-to-consumer (DTC) pharmaceutical advertising. During a wide-ranging FDA podcast 10/16, Makary criticized certain drug ads for relying on distracting visuals such as “singing and dancing … marching in some fake town” rather than clearly communicating what the drug is for and its associated risks.

In September, FDA began issuing letters in response to its crackdown efforts (see earlier story) on DTC advertising, including what it described as about 100 cease-and-desist letters plus dozens of Warning or untitled letters to companies questionably promoting prescription drugs.

Makary emphasized that the agency is now moving to close a key “adequate provision” loophole. Under longstanding rules, FDA's adequate provision policy for drug advertising allowed broadcast ads to include a brief mention of major risks and then direct consumers to other sources for complete safety information. This policy was created to make broadcast advertising more practical, but it is now being phased out, he noted. The agency plans to eliminate the adequate provision rule through rulemaking, requiring more risk information to appear in the ad itself.

Makary added that DTC enforcement had become lax in recent years, saying that zero enforcement letters were sent last year, and only one the year before. He said pharmaceutical advertising has for years prioritized stylized marketing over clear communication of benefits and risks.

During the podcast, Makary said that many FDA advertising and promotion reviewers previously felt “demoralized,” and when he visited them to unveil the enforcement push, many “had a list ready” to send enforcement letters but lacked the “directive from above” to act. “They knew every drug that was in violation,” Makary said. “Now they were telling me how happy they are that they’ve been able to send these out.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome