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FDA Secret Leaks Hurt Drug Rivals, Firm Claims
12 Jul
Summary
- An anonymous company petition asks the FDA to stop publishing complete response letters.
- The FDA began publicly disclosing reasons for drug rejections in July 2025.
- The company argues publishing rejection details gives competitors an unfair advantage.
A pharmaceutical company has submitted an anonymous petition to the Food and Drug Administration (FDA) urging a reconsideration of its protocol for publicly disclosing complete response letters (CRLs). Since July 2025, the FDA has been publishing the reasons why drugs fail to reach the market, a policy intended to increase transparency for patients and investors. This move followed an analysis revealing that companies previously omitted significant safety and effectiveness concerns when announcing rejections.
However, the unnamed company contends that this open disclosure policy causes "competitive harm." It argues that publishing the exact recommendations the FDA provides for drug fixes allows rivals working on similar medications to gain an unfair advantage. The petition specifically cites an example where an FDA recommendation for a company called Immedica became public knowledge. This has led to a noticeable pause in FDA's CRL publications, with none posted since April 22, 2026.
This issue has surfaced amid ongoing trade concerns and has drawn attention to the FDA's communication practices. Even before the petition, tensions were evident. Following the publication of a rejection letter for Capricor Therapeutics' cell therapy in September 2025, the company stated the FDA had not warned it about the public release and omitted its rebuttal. This situation is further complicated by the FDA's own budget request to Congress, made approximately two and a half weeks before the petition's filing, seeking formal legal power to continue disclosing these letters.
