Regulatory & Policy

FDA pauses CRL publication while HHS develops formal disclosure rule

Category: Regulatory Policy | Regulatory Body: FDA | Geography: United States | Instrument: Rule/Rulemaking

Edited by Robert McTiernan··3 min read
FDA pauses CRL publication while HHS develops formal disclosure rule

What Happened

According to reporting by Fierce Biotech, the FDA has temporarily suspended its policy of publicly releasing FDA drug rejection letters — formally known as complete response letters (CRLs) — following a citizen's petition filed in April by an undisclosed pharmaceutical company represented by Covington & Burling. The pause, confirmed by a Department of Health and Human Services spokesperson, halts a pharmaceutical rejection disclosure initiative championed by Health Secretary Robert F. Kennedy, Jr., and former FDA Commissioner Marty Makary. The most recent CRL in the agency's database dates to April 22, 2026; subsequent rejections, including a late-June denial of a gout candidate from Sobi, have not been accompanied by published letters.

What It Covers

The CRL disclosure policy, announced in September 2025, was designed to publish drug rejection letters in real time as part of a broader FDA transparency policy agenda at the agency. Prior to the pause, the FDA had released two tranches of historical CRLs — 200 letters in July 2025 and 89 more in September — covering high-profile drug application denials including Ultragenyx's gene therapy for Sanfilippo syndrome type A, Capricor Therapeutics' Duchenne muscular dystrophy cell therapy, and Replimune's melanoma candidate vusolimogene oderparepvec.

The citizen's petition challenged the CRL disclosure policy on grounds that the agency had failed to adequately involve sponsors in the disclosure process and had not fully redacted confidential commercial information, citing specific instances of unredacted material in published letters. In parallel with the pause, HHS is working to formalize the policy through rulemaking, according to the spokesperson cited by Fierce Biotech. Former Commissioner Makary also requested that Congress amend the Federal Food, Drug, and Cosmetic Act to explicitly authorize CRL disclosure before his departure from the agency in May 2026.

Why FDA Drug Rejection Letters Disclosure Matters

The pause creates immediate strategic ambiguity for drug developers whose applications are currently under review or have recently received rejection decisions: it is now unclear whether and when their CRLs will be made public, or under what procedural safeguards. Documented instances of inadequate redaction — affecting sponsors including Lykos Therapeutics and Stealth BioTherapeutics — underscore that the original rollout lacked sufficient confidentiality controls, exposing companies to competitive intelligence risks and potential harm to ongoing development programs.

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The parallel rulemaking and legislative push signal that the underlying transparency objective has not been abandoned; the policy is being restructured, not reversed. Sponsors may need to prepare for public CRL disclosure as a near-term operational reality. The eventual formalization of CRL disclosure will fundamentally alter how failed applications are managed — requiring more proactive communication strategies and tighter coordination between regulatory affairs, legal, and investor relations functions.

What to Watch

  • Rulemaking timeline and scope: Monitor the FDA's proposed rule for its definition of what constitutes confidential commercial information within a CRL, the notice-and-comment period, and whether the final rule includes mandatory pre-disclosure review rights for sponsors.
  • Congressional action: Track whether Makary's legislative request advances under acting Commissioner Kyle Diamantas, and how a statutory amendment to the FD&C Act might interact with or supersede the agency's rulemaking process.
  • Petition outcome and redaction standards: The FDA's formal response to the citizen's petition will likely define the procedural requirements — including sponsor notification windows and redaction protocols — that govern any resumed CRL releases.
  • Pending CRL disclosures: Companies with recent rejection decisions, including Sobi, may face a backlog of unpublished letters may be released once the policy is re-established, potentially with little advance notice depending on how the new framework is structured.

Source: Fierce Biotech, July 9, 2026

This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/

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