Advertising Experts Critique FDA’s Increasing Enforcement

Pharmaceutical advertising experts joined the Food and Drug Law Institute’s annual conference in Washington, DC 5/6 to share their reactions to FDA’s dramatically altered enforcement approach toward prescription drug promotion since last fall, creating new uncertainty for industry as the agency ramps up scrutiny of direct-to-consumer (DTC) advertising, social media promotions and oncology marketing claims. Panelists described an FDA environment where Untitled and Warning Letters are being issued at a pace far exceeding prior years, while key internal review structures inside CDER’s Office of Prescription Drug Promotion (OPDP) have been diminished or eliminated amid staffing changes.

“There have been a number of big changes that have happened over the course of the last six months at FDA and how they are overseeing the regulation of drug advertising and promotion,” said moderator Melissa Mannion, pointing to a crackdown on DTC advertising that began in September.

The panel included Josh Oyster, Dominic Cirincione, Lauren Roth and Michael Ostheimer.

Cirincione, who previously served as OPDP lead regulatory counsel before joining Takeda, described what he called a historically “multidisciplinary, detailed, deliberate approach” to OPDP enforcement before recent organizational changes. According to Cirincione, OPDP compliance reviews traditionally involved formal internal memoranda, consultations with review divisions and statisticians, social science input for DTC materials, multiple management reviews and clearance from FDA’s Office of Chief Counsel before letters were issued publicly.

“I will say that consultation process, at least the internal one, is probably not happening right now,” Cirincione said, citing the absence of regulatory counsel teams, social science staff and management layers that previously participated in reviews.

Panelists said the increase in enforcement activity appears tied less to changing advertising practices than to leadership priorities under HHS secretary Robert F. Kennedy Jr. and FDA commissioner Marty Makary.

Roth, a partner at King & Spalding and former FDA Associate Commissioner for Policy, said Kennedy had repeatedly criticized DTC pharmaceutical advertising before joining the administration and suggested the current wave of enforcement reflects an effort to use existing FDA authorities more aggressively after concluding an outright ban on drug advertising would likely be legally untenable. “Conditions in the marketplace didn’t change very much, but the conditions at FDA changed very dramatically with the change in administration,” Roth said.

Still, panelists emphasized that FDA’s recent enforcement has extended beyond television advertising. Recent agency letters have addressed Facebook advertisements, consumer-facing Web sites, YouTube videos and oncology promotional materials.

Several speakers highlighted what they described as substantive changes in the structure and tone of recent OPDP letters. Cirincione noted that newer letters frequently omit detailed legal citations, background explanations and public health rationales that historically accompanied enforcement actions. “The threshold for what would constitute a false or misleading promotional communication has been lowered,” he said.

Panelists pointed specifically to FDA objections involving quality-of-life claims, “transformative relief” language and the presentation of time-to-event endpoints from single-arm oncology studies without comparator data. Ropes & Gray partner Oyster said some recent FDA positions raise difficult legal and constitutional questions, including agency assertions that certain single-arm oncology data presentations may be inherently misleading regardless of disclaimers or contextual explanations.

He also cited Warning Letters tied to an Oprah Winfrey television special discussing GLP-1 weight-loss drugs, arguing the agency did not clearly explain why portions of the broadcast constituted manufacturer advertising or labeling. “The letter doesn’t explain that. It just sort of asserts jurisdiction over it,” Oyster said.

Industry responses have varied, but speakers said many companies are becoming more conservative in their advertising strategies and increasingly seeking advisory comments from FDA before launching potentially sensitive communications. Roth said companies are requesting more advance discussions with OPDP and FDA lawyers about scientific exchange and clinical trial communications that may fall outside existing agency safe harbors. One recent interaction with FDA, she said, resulted in the agency permitting proposed communications to proceed after the sponsor added enhanced disclosures.

Cirincione strongly encouraged companies to continue using the advisory comment process despite the additional time involved, saying it provides an important record of FDA thinking and can guide future promotional campaigns.

Panelists also discussed speculation that FDA could eventually attempt to revisit the “adequate provision” framework that has long enabled broadcast DTC advertising by allowing companies to direct consumers elsewhere for full prescribing information. Cirincione said FDA would face substantial scientific and legal challenges if it attempted to require full risk disclosures in television advertisements because agency research has historically shown that excessive risk information can impair consumer comprehension.

Roth said she doubted the administration would complete a formal rulemaking during the current presidential term, noting that no proposal has yet appeared at the White House Office of Management and Budget despite months of public discussion.

The panel also focused heavily on social media, influencers and online video promotions, areas panelists said could become a major future enforcement priority. Oyster noted that FDA previously issued enforcement letters involving influencers, including Kim Kardashian, Nate Berkus and Serena Williams, but has not yet launched a broad new wave of influencer-focused enforcement during the current crackdown. Still, several panelists said recent statements from Makary and HHS officials suggest online advertising and influencer promotions remain under active scrutiny.

Cirincione pointed to a recent FDA enforcement letter involving a Spanish-language YouTube video for a prescription drug that applied major statement and consumer comprehension standards to internet-based video content — something he said OPDP historically avoided doing explicitly.

The discussion concluded with practical recommendations for advertisers navigating the evolving enforcement environment. Roth advised companies to conduct “360-degree” risk assessments accounting for FDA, FTC, state attorneys general and private litigation exposure. Cirincione again encouraged sponsors to use FDA advisory comments when possible.

Oyster offered a more tactical recommendation for television advertisers: “Shoot a lot of B-roll.” He said many companies are now building alternative edits into campaigns in anticipation of possible FDA objections over visuals, pacing or major statement presentation.