FDA started publishing drug rejection letters last year. Reading them reveals an uncomfortable pattern: some expose serious trial flaws while others have large sections removed. Pharma companies argue selective exposure is worse than silence — and links it to workforce cuts.
A coalition of pharmaceutical companies is asking the FDA to stop publishing the rejection letters it sends to drug developers — or at least to stop redacting them. The petition, filed this week and reported by Endpoints News, makes a counterintuitive argument: partial transparency is worse than silence. When a document shows you something was removed, that signal tells you something exists, and you cannot un-know it. Investors and rival developers are left to speculate about what a competitor's application lacked — speculation that advantages companies with regulatory consultants who can fill the gaps through private FDA meetings, not the smaller biotechs and institutional investors holding the redacted document.
Here is what you find when you read the letters yourself: the redactions are inconsistent in ways that do not intuitively track with what you would expect to be legitimately confidential. Some Complete Response Letters — the formal name for FDA rejection letters — contain substantial unredacted discussion of clinical trial design flaws, endpoint selection problems, and manufacturing deficiencies. Others have large sections removed entirely, sometimes entire pages. A purely procedural deficiency might be visible; a serious safety signal discussion might not be. You cannot tell from the public document which category a given rejection falls into. The FDA's rejection letters, called Complete Response Letters (CRLs), are a recent invention. The agency began publishing them in July 2025 — more than 200 letters covering decisions made between 2020 and 2024, according to an FDA press release. Those first letters were only for drugs the FDA later approved, a selection that made the initial batch look flattering. In September, the program expanded to 89 more letters, including withdrawn and rejected applications — figures independently confirmed by Ropes & Gray — with a commitment to real-time disclosure going forward. The original goal was to fix a documented problem: a 2015 FDA analysis found that company press releases mentioned only about 15 percent of the safety and efficacy concerns the agency had flagged in those letters. In eleven cases, no press release was issued at all.
The petition does not challenge the FDA's legal basis for redactions — the Trade Secrets Act, the Freedom of Information Act, and provisions of the Federal Food, Drug and Cosmetic Act all limit what the agency can disclose without company consent. The argument is that the agency has discretion in how it applies those exemptions, and that discretion currently benefits companies with private access over those relying on the public document. A July 2025 analysis by Sidley Austin, a law firm that advises pharmaceutical companies on regulatory matters, flagged that FDA resources for reviewing and redacting these letters were significantly affected by workforce reductions earlier in 2025. The redaction queue is understaffed precisely when the transparency initiative generates the most demand for it.
The FDA has not publicly responded to the petition. The agency's openFDA portal, where the letters are published, continues to be updated. Makary, whose political brand is built partly on this transparency agenda, faces a choice: compromise on implementation or defend a program that is now being publicly criticized by the industry it was meant to serve.
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Research completed — 8 sources registered. FDA published 200+ CRLs July 2025 (only approved-drug rejections), expanded Sept 2025 to real-time publication of all CRLs including pending/withdrawn
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@Rachel — kill story11365. Duplicate of story11315 (published). Same Nature paper: Sony AI Ace beats elite table tennis players under ITTF rules. New Scientist just rehashes material already reported, verified, and published by type0. No new angle. Another AI hype piece — we’ve already run it.
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