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# Will the Push for DTC Pre-Review Grow?
- URL: https://www.fdaweb.com/will-the-push-for-dtc-pre-review-grow/
- Published: 2026-04-09T12:00:00.000Z
- Updated: 2026-09-14T13:37:07.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5160955

Attorneys **Charles Snow** and **Dara Levy** (Hyman, Phelps & McNamara) say a bipartisan effort led by Sens. **Richard Durbin** (D-IL) and **Roger Marshall** (R-KS) to push FDA to take a more positive role in early review of prescription drug direct-to-consumer ads, coupled with heightened FDA enforcement actions on advertising in recent months, suggests “a growing congressional and regulatory appetite to rethink” how the system of prescription drug DTC advertising should work in the U.S. Durbin and Marshall [said](https://www.fdaweb.com/bipartisan-senators-urge-fda-to-pre-screen-certain-drug-ads/) the agency should use its existing authority to require certain ads to be submitted for review before they are aired on television. They said that while FDA reviews ads after they have aired, it has had the authority since 2007 to mandate pre-review for some high-risk promotions, but has never exercised that authority.

Writing in their firm’s *FDA Law Blog*, Snow and Levy [say](https://www.thefdalawblog.com/2026/04/bipartisan-push-for-fda-pre-review-of-dtc-drug-ads/??ref=fdaweb.com) FDA issued a 2012 draft guidance on pre-dissemination review that was never finalized and now has disappeared from the agency’s Web site. They point out that many companies have been voluntarily submitting their ads for pre-review. “It is important to note that the animating statute explicitly denies FDA the authority to require industry to implement changes to their television ads, excepting certain specific disclosures (e.g., serious risk). However, given the significant risk of an enforcement action, companies generally modify their content to address FDA concerns,” they write.

The attorneys say that if FDA leadership decides to embrace its pre-review authority, there could be these ripple effects:

- increased promotional timelines arising from delays in pre-review clearance due to FDA’s operational capacity;
- an increased strain on internal resources for industry;
- early and often engagement with FDA; and
- a regulatory/industry shift in philosophy emphasizing identifying and remediating misleading promotion before it reaches the airwaves.

“If the pre-review process were more widely and rigorously applied to finished television ads, the costs of changing a television ad to obviate FDA’s concerns could prove to be another effective tactic that would effectively reduce the universe of misleading DTC ads,” the attorneys say. “In addition, whether intentionally or unintentionally, this also may reduce the sheer number of television ads due to the costs and time involved in bringing an ad to fruition under the more rigorously applied pre-review process…. It’s important to note that FDA review of a final television ad before airing, as opposed to a storyboard before filming of the television ad, is two very different substantive reviews.”

If Durbin and Marshall’s call to action gains traction and support, the post concludes, the question will no longer be whether FDA should act, but rather how early the agency should act. “In an environment where HHS and FDA leaders have focused (improperly we might add) on the ‘adequate provision loophole’ as a means to curtail prescription drug ads, FDA could more effectively reduce the number of ads by simply embracing its already granted statutory authority to require FDA pre-review.”