> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# OPDP Issued 30 Enforcement Letters in FY 2026; Director Says Many Were Avoidable
- URL: https://www.fdaweb.com/opdp-issued-30-enforcement-letters-in-fy-2026-director-says-many-were-avoidable/
- Published: 2026-10-30T16:25:40.000Z
- Updated: 2026-10-30T16:25:40.000Z
- Author: David McFarland
- Tags: Drugs

CDER’s Office of Prescription Drug Promotion (OPDP) issued 30 enforcement letters during fiscal year 2026, including 28 untitled letters and two warning letters, according to office director Twyla Mosey, who told a Food and Drug Law Institute conference that many promotional violations might have been avoided if drugmakers had sought agency feedback before disseminating their materials. 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/)).

Speaking at the 10/28 FDLI advertising and promotion conference, Mosey said OPDP received more than 172,000 promotional materials submitted on Form FDA-2253 during FY 2026, including more than 111,000 materials directed at healthcare professionals and more than 60,000 consumer-directed materials.

The office also received more than 100 requests for advisory comments on proposed promotional communications. Mosey encouraged manufacturers to consult FDA before launching advertising campaigns and to seek clarification or additional review when necessary. She said a meaningful number of enforcement letters could have been avoided through greater use of the agency's voluntary advisory process.

The enforcement actions involved television advertisements, direct-to-consumer videos, social media, exhibit booths and patient brochures across multiple therapeutic areas. Mosey identified several recurring violations, including omission or minimization of risk information, efficacy claims unsupported by clinical evidence, misleading comparative superiority claims and failure to accurately communicate FDA-approved indications.

She also warned that disclaimers cannot remedy claims based on inadequate studies or misleading presentations of clinical data.

Mosey reported that FDA's [Bad Ad program](https://www.fda.gov/drugs/prescription-drug-advertising/bad-ad-program?ref=fdaweb.com) received more than 350 complaints during the year and has received more than 4,000 reports since its inception. The program solicits reports of potentially false or misleading prescription drug promotion, including from healthcare professionals attending medical conferences. Mosey said OPDP continues to use a risk-based approach in evaluating complaints and promotional violations.

She told conference attendees that manufacturers must evaluate the overall presentation of their television advertisements, not simply whether required risk information is included. Her comments focused on FDA's clear, conspicuous and neutral (CCN) rule, which governs how the major statement of prescription drug risks must be presented in direct-to-consumer television and radio advertising.

Mosey said advertisements may cross the regulatory line when visuals, music, scenery or on-screen action distract viewers from the risk information being communicated.

The concern extends to advertisements that include the required risk information but whose presentation prevents consumers from adequately absorbing important safety information. Mosey encouraged manufacturers to evaluate advertisements from the perspective of an ordinary consumer and consider whether someone seeing an advertisement for the first time would understand both its benefits and risks.

She also reminded sponsors of the rule's dual-modality requirement for television advertising, under which the major statement of risks must be presented simultaneously in audio and text.