FDA Pauses Real-Time Release of Drug Rejection Letters While Working to Formalize Policy

The FDA has quietly paused its policy of releasing complete response letters (CRLs) in real time, according to reporting from Fierce Biotech, following a citizen's petition filed by an unnamed pharmaceutical company in April.¹

A Department of Health and Human Services spokesperson confirmed to Fierce that the agency "temporarily paused" the effort starting in April and is currently "evaluating the process and potential next steps."

The most recent rejection added to the FDA's database is the April 22 denial of AbbVie's investigational botulinum toxin trenibotulinumtoxinE. More recent rejections, including a late June denial of a gout treatment from Sobi, have not had corresponding CRLs published.

A transparency push now under review

The CRL release policy was a signature element of the "radical transparency" initiative championed by former FDA Commissioner Marty Makary and Health Secretary Robert F. Kennedy Jr. The FDA announced the plan last September, accompanying it with a release of 89 letters covering recent high-profile rejections including Ultragenyx's gene therapy for Sanfilippo syndrome type A, Capricor Therapeutics' Duchenne muscular dystrophy cell therapy, and Replimune's melanoma drug vusolimogene oderparepvec. That release followed an earlier drop of more than 200 CRLs in July 2025.

The legal challenge came from law firm Covington and Burling, writing on behalf of an undisclosed pharmaceutical company. The petition argued that the FDA needed to more meaningfully involve companies in the disclosure process and ensure all confidential commercial information was fully redacted before letters were made public. It cited specific instances of unredacted material in published CRLs, including rejections for Lykos Therapeutics and Stealth BioTherapeutics.

Capricor added its own objection when its CRL was published, stating the company had not been notified in advance and accusing the FDA of misinterpreting its efficacy data.

Despite the pause, the FDA has not abandoned the underlying goal. The agency has proposed a rule that would expand the commissioner's authority to release CRLs and eliminate what it described as a longstanding presumption that the existence of a marketing application constitutes confidential commercial information. Before his departure in May, Makary also asked Congress to amend the Federal Food, Drug, and Cosmetic Act to explicitly authorize the release of CRL information. Makary has since been replaced on an acting basis by Kyle Diamantas.

What the initiative was designed to address

The original rationale behind the CRL release program was well-documented. When Applied Clinical Trials covered the July 2025 release of more than 200 letters, the core argument was that the industry had long operated with a significant information gap.²

Previously, CRLs were shared only with product sponsors, allowing companies to downplay or omit the FDA's stated concerns from public disclosures. A 2015 analysis found that 85% of safety and efficacy issues cited in CRLs were never publicly disclosed by sponsors. In roughly 40% of cases where the FDA requested new clinical trials to address safety or efficacy concerns, that requirement was not communicated in press releases.

Among the 200-plus letters reviewed, 48% cited deficiencies in both safety and efficacy domains. Of 32 CRLs that called for new clinical trials, only 59% had press releases acknowledging that requirement. Among seven CRLs citing increased mortality in treated participants, only one corresponding press release disclosed that outcome.

"For far too long, drug developers have been playing a guessing game when navigating the FDA," Makary said at the time of the initial release.

Industry perspective on trial design

The CRL transparency effort arrived alongside a period of heightened scrutiny of trial design that prompted clinical operations teams to rethink how they structure protocols.

In a video interview with ACT last summer, Meri Beckwith, co-CEO of Lindus Health, argued that sponsors pursuing expedited pathways need to build more flexibility and control into their studies from the outset—and that technology now makes that more achievable than it once was.³

Beckwith pointed to adaptive randomization and synthetic control groups as practical, relatively low-cost tools for reducing regulatory risk, particularly in indications where a conventional randomized controlled trial would face ethical barriers.

"Certainly, we hope that in the near future, every clinical trial will be adaptive by default, and I think there's really no reason not to," he said.

Whether the FDA's CRL program resumes in its current form, is restructured through rulemaking, or requires legislative action to proceed remains to be seen. For now, the pause leaves sponsors without the real-time visibility into rejection rationale that the initiative had briefly made available.

References

1. FDA halts release of new drug rejection letters while working to formalize policy. Fierce Biotech. July 8, 2026. Accessed July 10, 2026. https://www.fiercebiotech.com/biotech/fda-halts-release-new-drug-rejection-letters-while-working-formalize-policy

2. New FDA Initiative Reveals Common Reasons for Drug Application Rejection. Applied Clinical Trials. July 11, 2025. Accessed July 10, 2025. https://www.appliedclinicaltrialsonline.com/view/new-fda-initiative-reveals-common-reasons-drug-application-rejection

3. Future-Proofing Trial Protocols to Avoid CRLs. Applied Clinical Trials. August 15, 2025. Accessed July 10, 2026. https://www.appliedclinicaltrialsonline.com/view/future-proofing-trial-protocols-avoid-crls