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# FDA's Ad/Promo Enforcement Surge Undercutting Deterrent Effect: Attorneys
- URL: https://www.fdaweb.com/fdas-ad-promo-enforcement-surge-undercutting-its-deterrent-effect-attorneys-say/
- Published: 2026-11-02T17:26:51.000Z
- Updated: 2026-11-02T18:13:16.000Z
- Author: David McFarland
- Tags: enforcement

FDA's stepped-up enforcement against prescription drug advertising may be having an unintended consequence: Some pharmaceutical companies are becoming more willing to accept promotional risks because the agency has issued so many enforcement letters without consistently escalating to more serious actions, attorneys said during a recent Food and Drug Law Institute advertising and promotion conference panel.

CDER’s Office of Prescription Drug Promotion issued 30 enforcement letters during fiscal year 2026, including 28 untitled letters and two warning letters, according to office director **Twyla Mosey** ([see earlier story](https://www.fdaweb.com/opdp-issued-30-enforcement-letters-in-fy-2026-director-says-many-were-avoidable/)). The high volume of letters to drug companies followed the agency’s September 2025 crackdown on misleading direct-to-consumer and other prescription drug advertising ([see earlier story](https://www.fdaweb.com/fda-orders-crackdown-on-misleading-prescription-drug-ads/)).

Arnold & Porter senior associate **Jonathan Trinh** said the unprecedented volume of warning and untitled letters has changed how some companies assess the consequences of receiving an agency enforcement letter. He said companies receiving letters are no longer isolated cases, potentially making the actions less consequential in the eyes of commercial executives. Some companies have consequently become more willing to take promotional risks, particularly when FDA letters are not followed by additional enforcement.

He noted that repeat untitled letters do not necessarily result in Warning Letters or other enforcement measures. The observation prompted the panel’s moderator, Foley & Lardner partner **Kyle Y. Faget**, to suggest that the sheer volume of letters may have undercut their overall deterrent effect.

Trinh also observed that FDA's increased activity has also complicated discussions between commercial and regulatory personnel. While marketing executives may view the widespread issuance of letters as justification for accepting greater risk, regulatory officials continue to emphasize the agency's findings and potential consequences. Those consequences can extend beyond FDA, he cautioned, noting that enforcement letters can become issues in shareholder litigation and may affect stock prices.

Hogan Lovells partner **Melissa Mendoza** said many companies remain determined to avoid enforcement letters and are seeking greater assurance from FDA before proceeding with promotional campaigns.

Mendoza, former director of CBER’s Office of Compliance and Biologics Quality, said clients are particularly concerned about whether FDA will issue another large wave of letters and whether the agency's previously announced plans to use artificial intelligence to identify promotional violations have been implemented. She also suggested that companies receiving broad compliance communications followed by more specific warning or untitled letters could face uncertainty about whether FDA intends to escalate enforcement.

Overall, panelists generally agreed that FDA's enforcement actions have not reflected fundamentally new interpretations of advertising law. Instead, they attributed the increase largely to stronger leadership support for enforcement against longstanding violations, including inadequate risk disclosures, unsupported efficacy claims and misleading presentations of clinical evidence.

Despite differing assessments of the campaign's deterrent effect, the attorneys said companies are revisiting promotional review procedures, reassessing the evidence supporting advertising claims and paying closer attention to FDA's latest enforcement letters.