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# DTC Crackdown Unfazed at Post-Makary FDA: Expert
- URL: https://www.fdaweb.com/dtc-crackdown-unfazed-at-post-makary-fda-expert/
- Published: 2026-05-18T12:00:00.000Z
- Updated: 2026-09-14T13:39:25.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5161161

The sudden departure of former FDA commissioner **Marty Makary** is unlikely to result in major changes to the agency’s approach toward direct-to-consumer (DTC) pharmaceutical advertising, according to comments from industry consultant **Bob Ehrlich**, CEO of DTC Perspectives. In a [newsletter post](https://myemail.constantcontact.com/FDA-Leadership-Shakeup--What-It-Means-for-DTC-Advertising.html?soid=1123057792767&aid=BBYqQIkQzzk&ref=fdaweb.com) distributed 5/18, Ehrlich says he was “never surprised by the doings in Washington,” but described Makary’s exit as abrupt, citing rumors of disagreements with the administration over policy matters.

Makary had appeared only weeks earlier at the DTC National conference, where he reassured attendees that the agency was not pursuing a ban or severe restrictions on television drug advertising, Ehrlich notes. The comments were welcomed by pharmaceutical marketers after earlier political rhetoric raised concerns about possible curbs on TV advertising.

Ehrlich says he does not expect the FDA’s overall stance on DTC advertising to materially shift under a new commissioner. Instead, he pointed to increasingly aggressive enforcement by the agency’s Office of Prescription Drug Promotion (OPDP), which has issued a growing number of untitled letters challenging allegedly misleading promotional materials. “The industry has been put on notice that what was acceptable in the past will no longer be acceptable in 2026 and beyond,” Ehrlich writes.

According to Ehrlich, OPDP is demanding more restrained presentations of clinical benefits and is scrutinizing advertising imagery that could imply efficacy beyond what has been demonstrated in clinical studies. Traditional DTC advertising tropes — including highly active or dramatically transformed patients — are increasingly drawing regulatory attention when they appear to overstate treatment outcomes.

Ehrlich estimates that the likelihood of receiving an FDA enforcement letter has risen substantially, particularly for advertisements that have not undergone FDA pre-clearance review. He also says Makary had suggested the FDA was considering stronger enforcement mechanisms, potentially including statutory penalties tied to regulatory actions. Such penalties could include requirements for corrective advertising campaigns, which can be costly and reputationally damaging for manufacturers.

As a result, Ehrlich advised companies to seek FDA pre-clearance for advertisements that contain claims or imagery similar to themes cited in recent OPDP enforcement letters. Despite the tougher regulatory climate, Ehrlich says the traditional 60- to 90-second television ad format “still appears safe,” though likely in a more subdued form than in previous years.