An unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, alleging that the policy “contravenes decades of agency practice.”
The FDA will temporarily stop publicly releasing rejection letters amid a citizen petition challenging the legality of the effort.
The regulator “is evaluating the process and potential next steps,” a spokesperson for the Department of Health and Human Services told Fierce Biotech, which reported the news on Wednesday, noting that the pause started in April. BioSpace has reached out to the department for independent confirmation and for more details.
The pause deals a blow to the agency’s campaign of “radical transparency” in an effort to give the public “significantly greater insight into the FDA’s decision-making,” according to a July 2025 news release announcing the regulator’s publication of the rejection letters. The initial dump included more than 200 CRLs from the previous decade, spanning applications for novel drugs, biosimilars, injection devices and more.
A few months later, in September that year, the FDA released an additional cache of the letters and promised that it would soon start publishing them “promptly after they are issued to sponsors.”
Despite the letters being heavily redacted, analysts and investors for the most part lauded the measure, telling BioSpace in April that making the rejection letters publicly available has changed the way companies communicate these regulatory setbacks.
“The reception from the investment community has been unanimously positive,” TD Cowen’s Ritu Baral said at the time, noting that the trove “brings a level of accountability and professionalism to a sector that is far from mature.”
“There are smaller companies with less experienced management teams, and this gives communication some guardrails,” Baral said.
Not everyone has been pleased with the policy, however. Eva Temkin, formerly in the FDA’s Chief Counsel’s office and Office of New Drugs, and now a partner at Arnold & Porter, called the move a “shock-and-awe policy” during a panel at the BIO International Convention last month.
Temkin in particular took issue with how there had been little public consultation about the FDA’s decision to publish the CRLs—ironic given that the measure is meant to increase regulatory transparency: “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 with the agency, seeking reforms to the way the FDA releases these rejection letters. In particular, the petitioner wants the FDA to “first inform the manufacturer” that it intends to make the letter public and give the drug sponsor 10 days to contest the move.
“As a legal and policy matter, FDA should immediately cease publishing [CRLs],” the petition read, noting that the initiative itself is “unlawful” and “contravenes decades of agency practice with no adequate explanation.”
The FDA is required to respond to the petition within 180 days of receipt, which would be Oct. 17. No such response has yet been posted.
