FDA Puts Drug Rejection Letters on the Public Record—In Real Time

Commissioner Makary's 'radical transparency' push ends decades of confidentiality for complete response letters, with cytisinicline's manufacturing-only CRL arriving as one of the first under the new regime—and a Covington & Burling petition arguing the whole policy may be unlawful.

WASHINGTON — June 23, 2026 — The Food and Drug Administration has fundamentally changed the terms under which it rejects a drug: complete response letters, the formal documents telling a sponsor why an application cannot be approved, are now public the moment they are issued.

The policy, announced under Commissioner Dr. Marty Makary’s banner of “radical transparency,” ends an arrangement that had held for decades. Previously, a complete response letter (CRL) was confidential unless the sponsor chose to disclose it. Under the new regime, the FDA releases each letter simultaneously with sponsor notification, redacted only for trade secrets, confidential commercial information, and personal data—but with company names intact.

To mark the shift, the agency published a batch of 89 previously unpublished CRLs covering applications that were pending, withdrawn, or abandoned. A searchable database now lives at open.fda.gov, where letters associated with both approved and unapproved applications are indexed in a new transparency endpoint.

Cytisinicline: a live example

The policy’s real-world weight arrived almost immediately. On June 22, 2026, Achieve Life Sciences announced it had received a CRL for its New Drug Application for cytisinicline, a plant-derived partial nicotinic-receptor agonist under review as a smoking-cessation treatment. The letter, publicly released the same day under the new rules, cited outstanding manufacturing observations from a cGMP inspection of a third-party manufacturing facility and incomplete final product labeling—not clinical efficacy or safety concerns. The FDA raised no deficiencies regarding cytisinicline’s clinical data.

Cytisinicline holds Breakthrough Therapy designation (for nicotine e-cigarette/vaping dependence). Achieve Life Sciences said it intends to resubmit the NDA in the fourth quarter of 2026, naming Adare Pharma Solutions as its new primary commercial manufacturing partner, with a potential U.S. approval target in the first half of 2027.

A legal challenge takes shape

Not everyone accepts the policy as lawful. On April 21, 2026, the FDA received a citizen petition filed by Covington & Burling on behalf of an unnamed pharmaceutical company. The petition argues that real-time CRL disclosure may violate federal law—including FOIA, the Trade Secrets Act, and FDA’s own regulations—and that sponsors are denied notice and an opportunity to respond before their letters become public. The petitioners asked the agency to establish a process giving sponsors at least 10 days to contest a planned disclosure before it is made.

Separately, an attorney at Arnold & Porter has argued publicly that the releases of CRLs for unapproved drugs may also conflict with the Administrative Procedure Act.

As of publication, the FDA has not formally responded to the citizen petition, and no litigation has been filed. The policy remains in effect, and every NDA and BLA sponsor now faces the prospect that a rejection letter—whenever it comes—will be a matter of public record the same day it lands in their inbox.

Trace · every claim, sourced

Reported and written by Marcus Webb, FDA & Regulatory Desk, then each load-bearing claim was bound to the primary source it rests on and checked out-of-band against that source before publication. The full mapping is below — nothing here is taken on faith.

The FDA now releases complete response letters simultaneously with sponsor notification, redacted only for trade secrets, confidential commercial information, and personal data.

regulator FDA Announces Real-Time Release of CRLs — Batch of 89 Published FDA-CRL-realtime-89

The agency published a batch of 89 previously unpublished CRLs.

regulator FDA Announces Real-Time Release of CRLs — Batch of 89 Published FDA-CRL-realtime-89

Cytisinicline received a CRL on June 22, 2026 citing manufacturing deficiencies; no clinical efficacy or safety deficiencies were raised.

company Achieve Life Sciences CRL Press Release Achieve-cytisinicline-CRL

Covington & Burling filed a citizen petition on April 21, 2026 arguing the policy may violate FOIA, the Trade Secrets Act, and FDA's own regulations.

legal-analysis Expert: FDA Real-Time CRL Release May Violate Law — RAPS RAPS-CRL-law-analysis

After publication, a separate AI panel re-verifies every edition against these same sources. The running claim-confirmation rate and every correction are public on the accuracy ledger.