An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?
By Josh Morrison, President, 1Day Sooner
In April, the FDA paused real-time release of complete response letters (CRLs) after Covington & Burling filed a citizen petition on behalf of an unnamed drug manufacturer. The FDA issues CRLs to sponsors—usually pharmaceutical or biotechnology companies—when it has reviewed a potential drug or biologic product and determined that it cannot be approved in its current form. These documents do not necessarily represent a wholesale rejection of the product, and they often contain suggested pathways for improving the product’s chances of reaching the market. The petition has been received as the latest round in a long fight over transparency and trade secrets. But it also raises the practical question of whether the agency can redact these letters quickly and consistently enough to keep releasing them at all.
After pausing in April, the FDA formally confirmed the pause in July, only to resume releasing letters days later, leading to confusion surrounding the new policy. This is indicative of a general lack of clarity about what the FDA’s campaign for “radical transparency" should look like in practice. For instance, it has not been clear what the FDA considers to be an “appropriately redacted” CRL that can be publicly released. The choice to release them, then suspend release, and then un-suspend release points to a growing instability around this issue. It also directly undermines the intention behind the policy change, which was to create consistent and predictable processes.
While the agency moved on fairly swiftly from the pause, this moment drew attention to the extent to which the issue of CRLs has become and will likely remain a point of contention for the FDA heading into the reauthorization of PDUFA, which is expected to take place by the end of September next year. And implementation of CRL release is unlikely to last as a policy if the FDA cannot settle the legal status of this issue, particularly given the departure of former FDA commissioner Marty Makary, who was among the most vocal supporters of CRL release.
We’ve Been Here Before, Sort Of
While the FDA has typically treated CRLs as confidential commercial information, this is not the first time the FDA has attempted to revise its policies surrounding their status. The moments when the FDA has moved towards greater transparency draw attention to the perceived stakes of this issue for the various parties involved. In 2010, the FDA also attempted to move towards greater transparency with the public and industry. Its own transparency task force suggested that the FDA “should disclose the fact that the Agency has issued a… complete response letter… and should, at the same time, disclose the... complete response letter,” and sought public comment on this proposal.
The FDA did not act on the proposal, and industry objected that the letters contained confidential business information. Sponsors were instead left to decide what to disclose about their own CRLs, and they often disclosed selectively. A 2015 analysis by FDA researchers compared 61 CRLs with sponsors’ subsequent press releases and found that the releases reflected only 93 of the 687 reasons the agency had given for non-approval, about 14 percent—a figure the FDA now cites as evidence that selective disclosure “risks misleading patients and investors alike.” Later, commissioners revisited the idea. Scott Gottlieb spoke in favor of publishing CRLs at his confirmation hearing but ultimately decided against it. His explanation, posted on Twitter (now X) after he left the agency, is telling: "Issue for us was never industry objections; it was FDA resources. It would take lot of people power to redact CRLs for release."
Given this history, it is perhaps unsurprising that most media coverage of the current debate, along with many of the FDA's own policy moves and statements, have framed the release of CRLs as a debate fundamentally about the potential benefits of transparency versus the necessity of avoiding sharing trade secrets. In July, a spokesperson for the Department of Health and Human Services explained that the “FDA routinely considers public input, legal requirements and feedback from stakeholders when evaluating opportunities to improve its processes,” in an effort to reassure industry figures that the agency would continue “refining its approach.” However, this framing elides an important issue raised by the current petition that industry figures and the FDA should take seriously: who redacts these letters and how long does it take. This is the same concern that Gottlieb raised after leaving the agency. It has remained unresolved.
Pause! Sponsors Want A Heads Up
The petition's central procedural request is that the FDA grant notice before CRL publication. This would give sponsors a chance to contest redactions but would not necessarily require ending real-time release of CRLs. While it does suggest that the FDA's releases are unlawful, it is more forceful in its suggestion that the FDA pause until there is a process in place.
Sponsors who share proprietary data with a regulator deserve a predictable process. Sponsors, investors, and researchers put time and money into the development of potential products and they want to protect their opportunity to profit from that labor. The petition alleges that FDA redacted inconsistently, and that at least 36 released letters concerned applications that had never been made public. The agency has since acknowledged at least part of this. In the Transparency Roadmap it published earlier this month, the FDA said it would be mindful of sponsors’ securities-law disclosure obligations in timing the release of redacted letters, and that it intends to pursue rulemaking requiring public disclosure of the fact that a major application has been submitted. The latter would resolve the problem of the 36 letters going forward. It would not resolve the problem of inconsistent redaction.
When 1Day Sooner published a white paper on CRL publication in October 2025, we recommended that the FDA notify sponsors before publishing their letters and give them a window to object, as it already does for Freedom of Information Act requests under 21 CFR 20.61(e). We argued then that such a process might also strengthen the agency's legal position.
There is a difference, though, between that kind of bounded process — a fixed window, limited to specific redactions, with the agency keeping the final word — and what the petition asks for, which is a halt until a process exists. Moving in the petition’s direction would turn every CRL into a negotiation over the “appropriate” level of redaction in each case. Whether this program survives may well depend less on the FDA's legal authority to release CRLs than on whether it can redact letters quickly, consistently, and cheaply enough to keep up. If the FDA cannot, then a policy shift might stymie an already slow drug and biologic development process.
Might AI Make The Difference?
CRLs can be dozens of pages in length and reviewers must conduct line by line redactions of technically complex documents. This process has to align with other agency priorities and remove any information that might reveal confidential information about pipeline strategies or proprietary technologies. The FDA has also not yet fully addressed the backlog of older CRLs that need redaction before they can be released. Addressing these labor issues would make real-time release more realistic without compromising on the important work redaction performs.
The FDA could help mitigate the cost of additional redaction labor by using AI technologies. An important first step — a precondition of using AI tools for redaction — is clarifying policy. This is the same gap that the past six months, of back-and-forth exposed: until the agency can say what an “appropriately redacted” CRL is, staffers can neither train an AI tool to identify one nor will they have the clarity necessary to perform human oversight, and drug development processes will be slowed. Making changes to rectify this lack of clarity would allow the FDA to mirror processes already in use at the State Department, which uses machine learning to declassify diplomatic cables, and under development at the National Archives, which is piloting AI to redact personal information from FOIA responses. If the FDA can modernize its own redaction processes, then human labor can be focused on “validation and edge cases.”
None of this means handing redaction decisions to a machine. Industry’s complaint is precisely that redactions have been inconsistent, and a tool that produces a first pass for human reviewers to check is a way of making them more consistent, not less. With these systems in place, real-time release stops being a question of whether the FDA has the authority or the will to publish CRLs and becomes a question of whether it has the capacity. With PDUFA reauthorization approaching and the policy’s most vocal champion gone from the agency, that is the question the FDA needs to answer.
About The Author:
Josh Morrison is the founder and president of 1Day Sooner, a non-profit organization that represents healthy participants who altruistically enroll in clinical trials and advocates for policies that maximize the benefit of their efforts. He also founded Waitlist Zero and the Rikers Debate Project. He holds a JD from Harvard Law School.