The FDA in July 2025 made publicly available over 200 complete response letters—an initiative that the investment community sees as “unanimously positive,” analysts told BioSpace.
An unnamed pharma company has filed a citizen’s petition asking the FDA to reform its new policy of publicly releasing all rejection letters.
In particular, the company wants the agency to “establish a clear process” by which drug sponsors can respond to the proposed disclosure of complete response letters (CRL), according to the petition dated April 20. Before releasing a CRL, the FDA should “first inform the manufacturer that it intends to do so,” and give the sponsor the opportunity to contest the publication within 10 days.
If the agency nevertheless decides to push through with the release despite a company’s objection, it should “notify the manufacturer in writing and explain its reasoning,” the petition read.
The unnamed company, through the citizen petition, called the FDA’s release of CRLs “unlawful,” arguing that it “contravenes decades of agency practice with no adequate explanation.”
“As a legal and policy matter, FDA should immediately cease publishing” the rejection letters, the petition added.
The FDA is required to respond to citizen petitions within 180 days of receipt.
In July 2025, the FDA published more than 200 CRLs as part of its campaign for “radical transparency.” The trove, which can be accessed on the regulator’s website, has now grown to more than 300 rejection letters. The FDA has pledged to publish letters in real time, as with the recent second rejection of Replimune’s melanoma drug RP1.
The effort has been widely lauded by investors and analysts. “The reception from the investment community has been unanimously positive,” Ritu Baral, senior biotech analyst at TD Cowen, told BioSpace earlier this month.
“I think it 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,” she added.
But the unnamed pharma company cited intellectual property concerns for its opposition: “This competitively sensitive, nonpublic information that is being released under FDA’s new CRL practice is precisely the type of information that FDA is required to protect from disclosure under black-letter federal law.”
The petitioner also conducted their own survey of other drugmakers and found that “many of the released CRLs had not been disclosed or acknowledged by the application.” In some cases, the drug sponsors hadn’t even disclosed or announced that they had submitted a filing in the first place.
The FDA “should ensure that manufacturers have the opportunity to engage with FDA on redactions through a clear process designed to ensure that required redactions are completed prior to release,” the petition added.
