The Food and Drug Administration will temporarily stop publicly releasing rejection letters after a citizen petition challenged the legality of the agency's transparency initiative, according to a spokesperson for the Department of Health and Human Services on July 9. The pause reportedly began in April, with the agency currently evaluating its process and potential next steps.
The move interrupts the FDA’s campaign for what it called “radical transparency,” which aimed to provide greater insight into its decision-making by publishing complete response letters (CRLs) issued to drug sponsors. In July 2025, the FDA released more than 200 CRLs from the previous decade, covering applications for novel drugs, biosimilars, injection devices, and other products. A second batch was published in September that year, with plans announced to make future CRLs available shortly after issuance.
Analysts and investors have generally supported making these heavily redacted letters public. “The reception from the investment community has been unanimously positive,” said Ritu Baral of TD Cowen at that time. Baral added that this approach “brings a level of accountability and professionalism to a sector that is far from mature.” She also said, “There are smaller companies with less experienced management teams, and this gives communication some guardrails.”
However, not all stakeholders agreed with the policy. Eva Temkin—formerly with both the FDA’s Chief Counsel’s office and Office of New Drugs—called it a “shock-and-awe policy” during a panel at last month’s BIO International Convention. Temkin criticized what she described as limited public consultation before implementing such measures: “We’re going to force transparency, but we’re going to do it without transparent process,” she said.
In April, an unnamed pharmaceutical company filed a citizen petition requesting reforms so manufacturers would be notified before publication of their CRL and given ten days to contest disclosure. The petition stated: “As a legal and policy matter, FDA should immediately cease publishing [CRLs],” calling the initiative unlawful and inconsistent with longstanding practice.
The FDA is required to respond within 180 days of receiving such petitions; as of now, no response has been posted.
