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# Makary JAMA Piece Explains DTC Ad Crackdown
- URL: https://www.fdaweb.com/makary-jama-piece-explains-dtc-ad-crackdown/
- Published: 2025-09-12T12:00:00.000Z
- Updated: 2026-09-14T15:21:36.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5159861

FDA is moving to rein in direct-to-consumer (DTC) pharmaceutical advertising after decades of weak oversight allowed misleading promotions to flood the U.S. market, according to a new [*JAMA* article](https://jamanetwork.com/journals/jama/fullarticle/2839061?ref=fdaweb.com) by FDA commissioner **Martin Makary**. He called drug advertising a “public health crisis” in need of urgent intervention. The U.S. is one of only two countries that permit the ads, and a 1997 FDA policy change unleashed a surge in spending on glossy promotions that often downplay risks while encouraging patient demand for brand-name products, he explained, adding that ad spending has increased nearly 800% since that regulatory shift.

“Within a decade of the change, drug ads distorted the patient-doctor relationship and drove inappropriate prescribing,” Makary wrote. After years of declining enforcement, Makary said FDA is now shifting from a reactive, complaint-driven model to proactive monitoring across television, print, and digital platforms.

Makary signaled that FDA will close the so-called “adequate provision” loophole that has allowed companies to cite vague “major risk statements” while referring consumers to Web sites or inserts for full safety information. A review of prime-time ads found only one-third listed all contraindications. “Viewing safety information should not be a scavenger hunt,” Makary said.

Makary’s FDA also plans to target social media promotions, where paid influencers and others have promoted prescription drugs — sometimes controlled substances — without disclosing risks. A 2024 review cited in the article found that 100% of pharmaceutical social posts highlighted drug benefits, but only 33% mentioned harms, he said.

Makary’s *JAMA* viewpoint piece also addressed economic and clinical impacts, indicating that research has linked DTC ads to a 31% increase in U.S. drug spending since 1997, with lower-value drugs receiving disproportionately high ad budgets. Studies also show such advertising increases inappropriate prescribing when patients request specific drugs, he said.

“The regulatory neglect of the past 25 years ends now,” he wrote. “Americans deserve better than a system in which pharmaceutical companies exploit loopholes, mislead patients, and drive up health care costs.”