Drugs

Redact CRLs for Unapproved Applications: Petition

David McFarland

— 2 min read
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A 4/20 petition submitted by Covington & Burling to FDA on behalf of an unidentified major pharmaceutical company urges the agency to immediately establish a formal process for redacting confidential commercial information and trade secrets before releasing Complete Response Letters (CRLs) for unapproved drug and biologic applications.

Historically, the petition says, FDA has treated CRLs as confidential until a drug is approved. This practice protected sensitive details about clinical trial design, regulatory strategy, and proprietary data, it says. However, in 9/2025, FDA shifted course, releasing 89 previously unpublished CRLs for unapproved applications and announcing plans to publish future CRLs in real time. Since then, an additional 34 CRLs have been released, many without redacting sensitive information.

Covington argues that FDA’s new approach exposes highly sensitive information, including detailed clinical deficiencies and FDA recommendations, which competitors could use to shortcut their own development programs. For example, it says that the CRL for Applied Therapeutics’ novel treatment for classic galactosemia included unredacted discussions of why certain clinical endpoints were deemed inadequate. Similarly, the CRL for Stealth BioTherapeutics’ Barth Syndrome therapy revealed FDA’s concerns about study design and statistical methodology, information not previously disclosed by the sponsor.

The petition contends that such disclosures violate federal law, including the Freedom of Information Act (FOIA) Exemption 4 and the Trade Secrets Act, both of which protect confidential commercial information from public release. It also notes that FDA’s regulations and decades of precedent require such information to remain confidential until a drug is approved.

Beyond its legal arguments, the petition warns that premature disclosure of CRLs could:

  • mislead the public and healthcare professionals about a drug’s safety and effectiveness, since CRLs are technical documents that do not reflect subsequent sponsor responses or eventual approvals;
  • discourage innovation by making sponsors wary of pursuing novel clinical trial designs or regulatory strategies, fearing that their proprietary approaches could be exposed to competitors and
  • undermine investment in drug development as publicized deficiencies, even if minor or ultimately resolved, could erode investor confidence and jeopardize funding for resubmissions.

The petition calls on FDA to adopt a process similar to that used for FOIA requests. Specifically, it says, before releasing any CRL for an unapproved application, FDA should:

  • notify the sponsor and provide the proposed redacted version of the CRL;
  • allow at least 10 working days for the sponsor to object to any disclosures and propose additional redactions;
  • consider the sponsor’s objections and, if necessary, provide written explanations for any information FDA decides not to redact; and
  • delay publication for at least five working days after final notice, allowing sponsors to seek judicial relief if needed.

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