Bipartisan Push for FDA “Pre-Review” of DTC Drug Ads

As many of our blog readers already know, direct-to-consumer (“DTC”) prescription drug promotion has been a regulatory flashpoint for years, and especially recently with FDA’s DTC crackdown (see our previous posts here, here, and here), but a new bipartisan push suggests the conversation may be shifting from post-publication enforcement to pre-publication review for television ads.

This Most Recent Congressional Push

On March 31, 2026, Senators Dick Durbin (D-IL) and Roger Marshall (R-KS) urged FDA by letter to require pre-submission of certain DTC drug ads before they air.  The Senators’ request builds on prior legislative efforts and reflects growing bipartisan concern that existing enforcement may not be effective in curtailing the “sheer volume of deceptive [drug] advertisements.”  See our previous coverage of Senator Durbin voicing concerns over FDA’s operational capacity to review DTC prescription drug advertising during the various workforce reductions.

FDA has issued well over a hundred Warning and Untitled Letters since September 2025 for false or misleading prescription drug promotion across television, the internet, and social media.  Yet Durbin and Marshall posit the airwaves—and social media feeds—remain saturated with problematic messaging.

Their concern is straightforward:  Some companies may view post-hoc enforcement as simply the cost of doing business.

Why Doesn’t FDA Exercise its Review Authority?

Here’s the key “nuance”:  FDA, per 21 U.S.C. § 353c, already has authority to review prescription drug television advertising before it appears on the public’s TV screens. Although FDA never issued proposed rulemaking implementing § 353c, FDA did publish a Draft Guidance for Industry, “Direct-to-Consumer Television Advertisements – FDAAA DTC Television Ad Pre-Dissemination Review Program” (Draft Guidance) back in 2012, setting forth FDA’s intention to require sponsors to submit certain TV ads for pre-review.  The Draft Guidance, which was never finalized, has been removed from FDA’s website, although there was no FDA notification that it was being withdrawn.  Draft guidances, as well as final guidances, do not establish legally enforceable responsibilities.

Although FDA’s Draft Guidance was never finalized and even in the absence of a proposed rule, many within industry have voluntarily submitted TV ad storyboards or rough videos for FDA review and comment.  It is important to note that the animating statute, 21 U.S.C. § 353c(c), 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.

Durbin and Marshall highlight that the current environment warrants greater and more aggressive use of FDA’s pre-review authority, particularly for high-risk products and drugs with the greatest population health impact.  This would not be a small shift—it would represent a significant move toward front-end regulatory oversight.

What This Could Mean for Industry?

If FDA leadership decides to embrace pre-review authority, the ripple effects could be significant:  1) increased promotional timelines (i.e., delays in pre-review clearance due to FDA’s operational capacity—see our previous blog post cited above); 2) an increased strain on internal resources for industry (e.g., FDA requesting to review the finalized television ad rather than the storyboard and then requesting changes to the television ad); 3) early and often engagement with FDA; and 4) a regulatory/industry shift in philosophy emphasizing identifying and remediating misleading promotion before it reaches the airwaves.

However, pre-review does not always ensure detection and prevention of dissemination of misleading ads.  For example, in 2024, FDA issued an Untitled Letter to AbbVie, Inc. over its DTC promotion of its migraine medication Ubrelvy.  FDA issued the Untitled Letter because of a DTC television ad featuring Serena Williams, alleging the television ad made false or misleading efficacy claims; specifically, FDA alleged the ad implied the drug could quickly eliminate migraine pain after a single dose, even though clinical data show only about 19-22% of patients achieved freedom from pain within two hours, meaning most did not experience that outcome.  In footnote 6, FDA acknowledges review of a storyboard that suggests several hours pass between dosing and effect, but notes the time lapse is lost in the finished television ad.  See our previous post on the Untitled Letter here.

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.  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.  As mentioned above, 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 are two very different substantive reviews.

So What are the Takeaways?

The United States remains one of two countries that permits widespread DTC prescription drug advertising.  That reality has long shaped the pharmaceutical marketing landscape as well as the compliance challenges that come with it.  The current bipartisan push and recent FDA enforcement actions and statements suggest a growing congressional and regulatory appetite to rethink how that system is executed.

Whether FDA embraces pre-review authority fully, selectively, or not at all remains to be seen; however, this latest push crystallizes one potential key shift in FDA behavior—if the Senators’ call to action gains traction and support, the question will no longer be “Should FDA act?” but rather “How early should FDA act?”  And 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 television ads, FDA could more effectively reduce the number of ads by simply embracing its already granted statutory authority to require FDA pre-review.

We will continue to monitor and report on developments in the DTC drug advertising space.