FDA has started to halt the public release of complete response letters (CRL) while it evaluates a citizen petition challenging the legal basis of the practice.

The pause, which began in April 2026, threatens to unravel one of the agency's most visible transparency initiatives while also reigniting a debate over how far FDA can go in disclosing confidential regulatory correspondence without industry consent.

A spokesperson for the Department of Health and Human Services confirmed that the agency "is evaluating the process and potential next steps," but offered no timeline for resolution or indication of whether the publication policy would resume in its current form.¹

How did we get here?

FDA launched what it called a campaign of "radical transparency" in July 2025, publishing a cache of more than 200 complete response letters spanning the previous decade, covering applications for novel drugs, biosimilars, injection devices and more.² The letters were heavily redacted but still provided an unprecedented window into the agency's internal reasoning for rejecting drug approval applications. In September 2025, FDA released an additional tranche and pledged to begin publishing new letters promptly after issuing them to sponsors.³

The initiative was framed as an effort to give the public "significantly greater insight into the FDA's decision-making" and drew largely positive reactions from analysts and investors. TD Cowen's Ritu Baral said at the time that the trove "brings a level of accountability and professionalism to a sector that is far from mature," adding that smaller companies with less experienced management teams would benefit from the communications guardrails the policy creates. The reception from the investment community, she said, was "unanimously positive."

What is the legal challenge?

In April, an unnamed pharmaceutical company filed a citizen petition asking FDA to reform how it releases CRL’s.⁴ The petitioner's central objection is the company wants FDA to notify the drug sponsor before publishing a rejection letter and give it 10 days to contest the disclosure, while also arguing that the initiative itself is unlawful.

"As a legal and policy matter, FDA should immediately cease publishing [complete response letters]," the petition stated, calling the initiative something that "contravenes decades of agency practice with no adequate explanation."

FDA is required to respond to the petition within 180 days of receipt, putting the deadline at October 17. As of July 10, no response had been posted.

What happens next?

The pause leaves the policy in an uncertain state, as FDA has yet to say whether it will resume publishing letters, revise the program, or abandon it while the citizen petition is under review. The October deadline for a formal response will be a key marker, but the agency could act sooner.

Sources

1. FDA freezes CRL trove as ‘radical transparency’ push hits speedbump BioSpace July 9, 2026 https://www.biospace.com/fda/fda-freezes-crl-trove-as-radical-transparency-push-hits-speedbump
2. FDA Embraces Radical Transparency by Publishing Complete Response Letters U.S. Food and drug Association July 10, 2025 https://www.fda.gov/news-events/press-announcements/fda-embraces-radical-transparency-publishing-complete-response-letters
3. FDA Announces Real-Time Release of Complete Response Letters, Posts Previously Unpublished Batch of 89 U.S. food and Drug Association September 4, 2025 https://www.fda.gov/news-events/press-announcements/fda-announces-real-time-release-complete-response-letters-posts-previously-unpublished-batch-89 
4. Agency Rule List – 2026 U.S. General Services Administration Accessed July 10, 2026 https://www.reginfo.gov/public/do/eAgendaMain?operation=OPERATION_GET_AGENCY_RULE_LIST&currentPub=true&agencyCode=&showStage=active&agencyCd=0900&csrf_token=C0B6ACBF4D626D326F9722E8D1C8960644BAAEE8BF328F00B7FBFEFAF5B32D19D8D24859AA608E98CE0CD17F31F7FC0CC8FC