FDA Promotion Crackdown Enters New Phase: Attorneys
FDA’s intensified scrutiny of drug advertising is extending beyond direct-to-consumer (DTC) television and radio spots, with lawyers alerting companies to prepare for closer examination of promotional claims, supporting data, social-media content and the use of artificial intelligence.
The agency’s is approaching the one-year anniversary of its aggressive campaign against potentially misleading drug promotion. In 9/2025, it released 40 cease-and-desist (untitled) letters to drug companies as it unveiled a major push (see earlier story) to crack down on misleading DTC advertising.
As the agency enters the campaign’s second year, companies should not assume that enforcement is limited to DTC advertising, according to two attorneys who advise pharmaceutical and life sciences companies. Speaking during a recent episode of FDA Watch, Arnall Golden Gregory’s (AGG) Alan Minsk and Laura LaBrie discussed the sharp increase in FDA enforcement activity and the potential for significantly tighter restrictions on DTC and other promotional efforts.
Minsk, chair of the food and drug practice at AGG, said he has practiced FDA law for 33 years and has not seen a comparable volume of promotional enforcement in recent years. The “sheer volume” could have resulted from FDA’s Office of Prescription Drug Promotion using artificial intelligence (AI) to identify and process promotional material more quickly. The increased enforcement also reflects a broader transformation in how companies communicate with patients, he said. Traditional television and radio advertisements have been joined by social-media campaigns, influencers, digital advertising and other rapidly evolving technologies.
The attorneys said the potential use of AI by FDA is one of the most significant unanswered questions. Labrie said the speed and similarity of recent FDA letters suggest that AI could be playing a role in drafting enforcement correspondence and potentially reviewing promotional submissions.
Companies are also exploring AI for their own promotional review processes. Labrie cautioned, however, that she has not recommended relying on AI as a primary reviewer because the technology can miss the nuances of pharmaceutical advertising. Drug names, disease states and subtle distinctions in promotional language can create problems for automated systems, she said. Human reviewers remain important because promotional compliance often depends on context, nuance and the overall impression created by an advertisement.
Minsk similarly advised companies against relying exclusively on AI. While the technology could help generate ideas or identify potential issues, he said human reviewers still need to evaluate the substance and context of promotional material. The same issue could arise on FDA's side. Minsk speculated that the agency may use AI to review studies, journal articles and other references submitted by companies to support promotional claims.
The attorneys identified the substantiation of promotional claims as one of the most important areas of increased scrutiny. FDA has traditionally focused on issues such as fair balance, prominence of risk information, disclaimers, font size and placement of important safety information. But Minsk said the agency increasingly appears willing to examine the underlying studies and references supporting a claim.
That can include questions about study methodology, whether the evidence was retrospective or prospective, whether a cited article supports the claim as presented and whether relevant limitations or contradictory findings were disclosed. “The agency is really peeling more into the data,” Minsk said.
The shift means companies cannot necessarily rely on a reference simply because it appears to support a promotional statement. Reviewers need to understand the complete story told by the underlying evidence.
Minsk also highlighted FDA scrutiny of limitations of use. If a drug's approved indication includes a limitation of use, companies need to ensure that limitation receives appropriate prominence in promotional materials.
Another recurring issue is the use of qualifiers and disclaimers that technically appear in an advertisement but fail to correct its overall impression. FDA has criticized companies for using asterisks, daggers, small type or distant disclaimers to qualify prominent claims, according to the attorneys. The agency's position, Minsk said, is effectively that a disclaimer cannot rescue an otherwise misleading message if consumers are unlikely to connect the qualification with the claim it modifies.
The prominence and placement of risk information therefore remain critical, even as companies experiment with increasingly compact digital formats, they said.
Social media and influencer marketing are also emerging as particularly difficult areas for pharmaceutical marketers. LaBrie said companies must account not only for FDA requirements but also for the rules and technical limitations imposed by individual platforms.
Promotional teams may have to fit complete indications and appropriate risk information into increasingly constrained formats, while platforms can impose their own restrictions on language, targeting and presentation, she said. The challenge is especially acute when an approved indication is lengthy. Simplifying the language for social media can inadvertently omit important elements of the indication or minimize risk information.
Minsk said companies must resist the temptation to make promotional messages “simple” at the expense of completeness.
The attorneys expect influencer marketing and other forms of social-media promotion to remain important enforcement areas.
The biggest potential change, however, could come from a proposed regulation that would substantially increase the amount of safety information required in direct-to-consumer advertising. The administration’s Office of Management and Budget has listed a proposed regulation for this year that could move television and radio advertising toward requirements resembling the pre-1997 regulatory environment. Before FDA changed its approach to broadcast DTC advertising in the late 1990s, the amount of risk information required could make television and radio promotion impractical.
Minsk said it is too early to know what the eventual proposal will contain, but he expects constitutional and First Amendment issues to play a significant role. Rather than expressly prohibiting DTC advertising, he said, the government could impose requirements that make it extremely difficult or expensive to conduct such advertising — what he characterized as a possible “constructive prohibition.”
Labrie agreed that litigation and industry pushback are likely if the proposal significantly restricts DTC promotion. Both attorneys said a compromise could ultimately emerge, potentially through additional disclosures or longer advertisements rather than an outright prohibition. Another possibility is that pharmaceutical companies could shift spending from branded advertisements toward disease-awareness campaigns that do not identify a specific product.
The attorneys also urged companies to think carefully before challenging a competitor's advertising. LaBbrie said the first question should be whether the company is prepared for the competitor to examine its own promotional practices in response.
Minsk recommended that companies first determine what they want to accomplish. If the goal is simply to stop a competitor's promotion, a direct trade complaint to the competitor may sometimes be more effective than immediately going to FDA. Other potential avenues include FDA complaints, the National Advertising Division, the Federal Trade Commission and, in appropriate cases, litigation under the Lanham Act. But each route carries costs and risks.
A company should ask whether the disputed claim is sufficiently valuable to justify the expense of defending a counterclaim or regulatory challenge, Minsk said. If the claim provides little commercial value, abandoning it may be preferable to turning the dispute into a prolonged legal fight.
The overall message from the discussion was that pharmaceutical companies should expect continued scrutiny of promotional practices across virtually every channel. For now, the attorneys' advice is straightforward: companies should continue reviewing promotional material carefully, regardless of whether it is aimed at consumers or health care professionals, and should treat emerging technologies as tools that require human oversight rather than substitutes for it.