Having started to publish CRLs without consulting the public, the FDA is under pressure to change course amid concerns it failed to openly and fully evaluate a complex issue.
Former Commissioner Marty Makary lauded the FDA’s decision to publish complete response letters (CRLs) as a win for drug developers, investors and patients alike when he unveiled the policy in 2025. One year on, Makary is no longer FDA commissioner and the legal basis for the initiative remains uncertain, with recent rapid-fire news of a pause, resumption and ongoing commitment to the policy pointing to an evolving situation.
The FDA has considered publishing CRLs for a long time, Elizabeth Jungman, partner at Hogan Lovells and former FDA chief of staff, said during a session at the BIO International Convention 2026 in June. 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, fueling interest in a more transparent approach.
Yet during Jungman’s time at the FDA, which ended last year, the agency opted against publishing CRLs, in part because of legal concerns, the lawyer explained. Publishing certain CRLs is “just not legal,” Jungman said. The FDA’s regulations treat the existence of an application as confidential, suggesting that the release of a CRL for a publicly undisclosed submission could breach the agency’s own rules.
“I don’t see how you square that with the regulation,” Jungman said.
Barriers to transparency
Other experts share Jungman’s concerns. Hyman, Phelps & McNamara lawyers, including Peter Dickos, warned in a September blog post that “litigation may follow” the FDA’s CRL policy, in part because of rules against disclosing applications. Months later, law firm Covington & Burling raised many of the same legal concerns in a citizen petition that it filed with the FDA on behalf of an unnamed drugmaker.
“I’m not sure the new policy is right,” Eva Temkin, a partner at Arnold & Porter, told BioSpace via email. “It’s too complex an issue and it hasn’t been openly and fully vetted. Rather, FDA’s change in policy was premised on a very narrow view of the way this policy would impact drug development and, hence, patient access.”
The FDA subsequently moved to solidify the legal foundations underpinning the policy by proposing to amend the Federal Food, Drug, and Cosmetic Act (FDCA) and to publish a rule on CRL releases. The FDCA proposal, which seeks explicit authority to disclose CRL information, “sounds like an acknowledgment that FDA sees legal vulnerability in its current policy—and would like to shore it up if it can,” Dickos told BioSpace via email.
Through the proposed rule, the FDA said it plans to “eliminate the longstanding presumption that the mere existence of a marketing application constitutes confidential commercial information” to allow the disclosure of CRLs for unapproved drugs. Dickos is unsure whether the policy would even solve the legal issues.
“As to how much it changes the legal landscape, the devil may be in the details,” Dickos said. “For example, if it truly only addresses the issue of applications whose existence has not been previously disclosed, then it might still leave open other important issues around the content of released CRLs for unapproved applications.”
The information included in released CRLs is among the concerns raised in the citizen petition, with the law firm claiming that the FDA “left unredacted detailed and confidential clinical deficiency information that is highly competitively sensitive” in several published letters. For example, unredacted details in the CRL sent to Immedica Pharma, “provided a roadmap to competitors on how to achieve FDA approval,” according to the citizen petition.
Many of the CRLs released are in fact redacted, but the concern is over whether the agency caught all the sensitive information. Jungman said that previous discussions at FDA involved a potential process that would allow for sponsors to review the redactions and appeal for changes before a CRL was released. “There would be negotiation with the redaction teams,” she told the audience at BIO.
At that time, she and her colleagues determined they simply didn’t have the resources to institute such a system. When Makary implemented CRL releases last year, the agency essentially “solved this staffing problem by just not giving companies that chance to have that interactive process,” Jungman said.
She added that mistakes could be costly, with the individual FDA staffer potentially criminally liable if confidential information got out. “It was a lot of risk to take on,” Jungman recalled of the earlier discussions she’d been a part of. But, she added, “this administration has a significantly greater tolerance for legal risk.”
While noting uncertainty about the legal effect of the FDA’s rule, Dickos said that the rulemaking process “will certainly offer more transparency into the agency’s thinking and allow for public input.” The lawyer called the formal administrative process “a welcome sign,” adding that he expects “a robust discussion.” Temkin, who also applauded the call for feedback, is pushing for the FDA to stop posting CRLs until it’s formalized.
“While it’s likely too late to put the proverbial toothpaste back in the tube,” Temkin said, “I would like to see [the] FDA stop implementing this new policy [until it] receives feedback, considers that feedback and finalizes the rule accordingly.”
The situation today
As recently as last week, FDA was posting new CRLs to its online database. The latest letters came just days after the agency confirmed to media outlets that it had paused the program following the citizen petition.
As for the new rule, the agency has yet to publish a timetable for the process. For now, it remains unclear how the FDA is approaching the publication of CRLs.
There is no indication that the FDA is now providing applicants pre-disclosure notification ahead of a CRL release, as the Covington petition requested, Dickos said. It is possible that the agency has made a nuanced change, such as only releasing CRLs for publicly known applications, but Dickos has yet to see evidence to support that conclusion. The reasons for the pause and resumption are similarly opaque.
“I’ve seen reporting about the break in releases roughly coinciding with the timing of both the Covington CP [citizen petition] and Commissioner Makary’s departure,” Dickos said. “In my view, while it’s certainly possible, 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.”
Editor’s note: This story contains reporting contributed by Jef Akst from BIO 2026.
