FDA's Real-Time Release of Complete Response Letters Faces Legal Challenge Over Transparency Push
核心洞察
The FDA's July 2025 publication of complete response letters for unapproved drugs may violate agency regulations and the Administrative Procedure Act, according to legal experts speaking at the DIA Global Annual Meeting.
Attorney Eva Temkin argued that 21 CFR 20.61 prohibits disclosing the existence of an application before approval, and the FDA acted without public engagement or notice-and-comment rulemaking.
A citizen petition filed by Covington & Burling (搜索) on behalf of a pharmaceutical company requests a clear process allowing sponsors to review and respond to proposed CRL disclosures before publication.
The US Food and Drug Administration's initiative to publish complete response letters (CRLs) for unapproved drugs—launched in July 2025 under former Commissioner Marty Makary's "radical transparency" push—is facing mounting legal scrutiny, with experts arguing the practice may violate both the agency's own regulations and federal administrative law.
Speaking at the DIA Global Annual Meeting in Philadelphia on Monday, Eva Temkin, an attorney with Arnold & Porter (搜索), asserted that the FDA's publication of CRLs for unapproved products contravenes 21 CFR 20.61, which requires the agency to protect much of the information obtained in a pending application as a commercial secret. "There is an exception to this prohibition once the existence of the application or abbreviated application has been previously publicly disclosed or acknowledged," Temkin said, but noted this exception is rarely used.
The regulations explicitly prohibit the FDA from disclosing the existence of an application before issuing an approval letter or a tentative approval letter to the applicant—a restriction that also applies to Investigational New Drug (IND) applications. Information is only made public after a drug is approved, and any disclosures are redacted to safeguard confidential commercial information and trade secrets.
Legal and Procedural Concerns
Temkin emphasized that the FDA took this action without any public engagement, arguing that the failure to adhere to the notice-and-comment rulemaking process constitutes a violation of the Administrative Procedure Act. She stated that this matter should have undergone the public hearing process before implementation.
The legal challenge has since materialized in a formal citizen petition. On April 21, 2026, the FDA received a petition from law firm Covington & Burling (搜索), filed on behalf of a pharmaceutical company, requesting that the agency establish a clear process providing sponsors with notice and an opportunity to respond to proposed disclosures of CRLs associated with unapproved applications—whether pending or withdrawn.
Chilling Effect on Industry Dialogue
During a question-and-answer session, panel moderator Lina AlJuburi of Sanofi asked whether the publication of these letters has changed sponsors' regulatory strategies. Temkin reported observing "a lot of retrenchment" from the open dialogue that previously characterized discussions between the FDA and industry in application meetings.
"There is a lot more concern about what will be reflected in the meeting minutes," she said, adding that "if the CRL letters can be published on a dime, what is to prevent them from disclosing other parts of an application?"
FDA's Own Uncertainty
Amanda Conti, a senior research analyst at AgencyIQ, reported that in its annual federal budget request published on April 3, 2026, the FDA sought enhanced legislative authority regarding the publication of CRLs. The agency is requesting an amendment to the Federal Food, Drug, and Cosmetic Act (FDCA) to strengthen current disclosure requirements, which could potentially expand the range of information it makes available.
"Another read of the request is that the agency is also concerned it might lack the authority to release CRLs before drugs are approved," Conti said. She further noted that "similar to other Makary-led projects and programs, the future of the new CRL approach is unclear."
The Transparency Argument
Proponents of CRL publication argue that the letters contain valuable information about how the FDA makes regulatory decisions, with routine statistical and methodological concerns—such as p-values, selection bias, and endpoint validity—being matters of public interest rather than proprietary commercial secrets. The debate centers on whether individual companies have a legitimate proprietary interest in keeping the FDA's basic scientific and statistical standards confidential, or whether greater transparency would ultimately benefit the entire drug development ecosystem by making regulatory expectations clearer in advance of clinical trials.
The outcome of the Covington citizen petition and any potential legislative action will likely determine whether the FDA's transparency initiative continues in its current form or is modified to include sponsor input before CRLs are made public.