The FDA has published 14 new rejection letters for drug applications, mere days after confirming to Fierce that a policy of releasing the documents had been paused in April.
The furthest back the new tranche of complete response letters (CRLs) goes is April 23, to the snubbing of Grace Therapeutics’ injectable form of nimodipine for aneurysmal subarachnoid hemorrhage. The most recent is the third rejection of an anti-PD-1/VEGFR combo from Hengrui Pharma and Elevar Therapeutics. Hengrui announced that refusal on July 10, the same day the FDA posted the 14 new CRLs to its database.
The agency announced a plan to publish CRLs in real-time last fall, but suspended the practice in April after a citizen petition was filed by an unnamed pharma company. A spokesperson for the Department of Health and Human Services (HHS) told Fierce last week that the FDA was “evaluating the process and potential next steps.”
HHS did not respond to a request for comment.
In challenging the policy, law firm Covington & Burling wrote on behalf of the undisclosed company that the agency needed to involve drug sponsors more in the disclosure process and be sure to fully redact all confidential information.
The CRL policy was part of a “radical transparency” push championed by Health Secretary Robert F. Kennedy, Jr., and former FDA Commissioner Marty Makary, M.D. The September 2025 announcement was accompanied by a set of 89 letters that followed an earlier drop of 200 CRLs last July.
The FDA has made efforts to formalize the policy. The regulator proposed a rule that would expand the commissioner’s ability to release CRLs and “eliminate the longstanding presumption that the mere existence of a marketing application constitutes confidential commercial information.”
In April 2026, Makary also asked Congress to amend the Federal Food, Drug, and Cosmetic Act to explicitly allow the agency to release information contained in CRLs, part of a suite of asks the now-departed commissioner made to lawmakers.