The Food and Drug Administration’s policy of publishing complete response letters, announced by former Commissioner Marty Makary in 2025, is facing ongoing legal uncertainty as of July 20. The agency has recently paused and resumed the initiative amid questions about its legal foundation and operational procedures.
Elizabeth Jungman, partner at Hogan Lovells and former FDA chief of staff, said during a session at the BIO International Convention 2026 that the FDA had long considered publishing these letters but refrained due to concerns over confidentiality. "It drives FDA workers 'crazy' when companies post press releases that 'bear a not-exact relationship with the actual CRL . . . that was issued,'" Jungman said. She added that regulations treat the existence of an application as confidential, raising questions about whether releasing such information could breach agency rules. "I don’t see how you square that with the regulation," Jungman said.
Legal experts share these concerns. Lawyers from Hyman, Phelps & McNamara warned in a September blog post that litigation could follow because of existing rules against disclosing applications. Law firm Covington & Burling echoed similar worries in a citizen petition filed on behalf of an unnamed drugmaker. Eva Temkin, partner at Arnold & Porter, said via email, "I’m not sure the new policy is right... It’s too complex an issue and it hasn’t been openly and fully vetted." Temkin also called for a pause in posting complete response letters until formal feedback is gathered.
To address these issues, the FDA has proposed amending the Federal Food, Drug, and Cosmetic Act to gain explicit authority to disclose information from complete response letters and plans to publish a rule on their release. Peter Dickos from Hyman, Phelps & McNamara said via email, "[The proposal] sounds like an acknowledgment that FDA sees legal vulnerability in its current policy—and would like to shore it up if it can." Dickos added: "As to how much it changes the legal landscape, the devil may be in the details." Concerns remain about unredacted sensitive information appearing in released documents; one example cited was detailed clinical deficiency data included in correspondence with Immedica Pharma.
Jungman described earlier discussions within FDA about allowing sponsors to review redactions before publication but noted resource constraints prevented this process from being implemented when Makary initiated public releases last year. She stated: "This administration has a significantly greater tolerance for legal risk." Dickos commented on recent events, "I’ve seen reporting about the break in releases roughly coinciding with...the Covington CP [citizen petition] and Commissioner Makary’s departure...without any clarification from the agency it’s hard to know for certain whether the ‘pause’ was prompted by one of those things, both or neither.”
Currently there is no indication applicants are notified before disclosure as requested by Covington's petitioners; reasons behind pauses or changes remain unclear. The timetable for finalizing new rules has yet to be published.
