Improved Public Information About FDA Rejection Letters

In July 2025 the Food and Drug Administration (FDA) announced the publication of “more than 200 decision letters” about new drugs and biological products, claiming that “the public now has significantly greater insight into the FDA’s decision-making and the most common deficiencies cited that sponsors must address before their application is approved.”[1]

Known as a “complete response letter,” the rejection letter states the reasons the agency declines an application, such as concerns about safety, efficacy, manufacturing deficiencies, bioequivalence or other issues. If the company resolves the concerns, the drug or biologic is usually approved. When made public, the letters are redacted to remove trade secrets and confidential commercial information.[2]

Almost immediately, the FDA’s announcement was recognized as being less of an advance than it seemed. The published letters were about applications submitted between 2020 and 2024, only about products that were eventually approved, and most were already public.[3] Other than 14 or so letters published for the first time, the major change was that the letters were easier to find on the FDA’s website.[4] Missing were complete response letters for rejected drugs that were never approved[5] and letters about more recent applications. A former FDA official aptly stated: “This is the lowest of the low-hanging fruit. It’s the rest of this that’s hard.”[6]

In September 2025, perhaps in response to such criticisms, the FDA released 89 previously unpublished complete response letters issued from 2024 to the present. The agency announced that, going forward, it “will promptly release newly issued [complete response letters], and when approving applications will release all [complete response letters] associated with that application.” The FDA “will also publish batches of previously issued [complete response letters] associated with withdrawn or abandoned applications.”[7] Company names will be released, but not commercial information, trade secrets, or any personal private information.

Complete response letters provide important information about the agency’s reasons for denying applications, thus informing the public and the medical community and allowing drug developers and other companies to avoid making similar mistakes. Moreover, companies often do not issue press releases after receiving a complete response letter, and when they do, the press releases often misrepresent or omit many of the FDA’s concerns.[8]

Instead, companies may try to recast the FDA’s letters in a positive light by selectively releasing information to the news media and downplaying or omitting the agency’s concerns about a drug’s safety and effectiveness. In a 2015 study, FDA researchers compared the content of complete response letters for new drugs with associated public announcements from sponsors. Their conclusion: “Press releases are incomplete substitutes for the detailed information contained in complete response letters.”[9]

Before he became FDA Commissioner, Scott Gottlieb advocated for the public release of complete response letters. However, as the commissioner in 2018, Gottlieb changed his mind because of the administrative challenges of redacting proprietary information.[10]

In contrast to the FDA, the European Medicines Agency (EMA) has a timely process for publishing marketing authorization decisions. If the EMA’s opinion is favorable, a summary document is published on the Friday after the meeting. Two weeks after the European Commission’s final decision, which happens later, full documentation is published. For negative recommendations, the timetable is the same. A refusal questions-and-answers document is published on the Friday after the meeting; full documentation is published two weeks after the final decision.[11]

The FDA seems to be following the EMA’s example by promptly making all its rejection letters publicly available. As discussed in the December 2024 issue of Worst Pills, Best Pills News,[12] the FDA could also revise its regulations to reduce the amount of information that it considers “confidential commercial information.”[13]
 

References

[1] FDA news release. FDA embraces radical transparency by publishing complete response letters. July 10, 2205. https://www.fda.gov/news-events/press-announcements/fda-embraces-radical-transparency-publishing-complete-response-letters. Accessed August 27, 2025.

[2] Ibid.

[3] Joseph A, Lawrence L. FDA publishes rejection letters sent to drugmakers, with a big caveat. STAT. July 10, 2025. https://www.statnews.com/2025/07/10/fda-publishes-drug-rejection-letters-marty-makary-transparency-effort/. Accessed August 27, 2025.

[4] OpenFDA. Complete response letters. https://open.fda.gov/apis/other/approved_CRLs/. Accessed August 27, 2025.

[5] Jewett C, Robbins R. F.D.A. posts collection of letters outlining concerns about new drugs. New York Times. July 10, 2025. https://www.nytimes.com/2025/07/10/health/fda-drugs-letters.html. Accessed August 27, 2025.

[6] Joseph A, Lawrence L. FDA publishes rejection letters sent to drugmakers, with a big caveat. STAT. July 10, 2025. https://www.statnews.com/2025/07/10/fda-publishes-drug-rejection-letters-marty-makary-transparency-effort/. Accessed August 27, 2025.

[7] FDA News Release. FDA announces real-time release of complete response letters, posts previously unpublished batch of 89. September 4, 2025. https://www.fda.gov/news-events/press-announcements/fda-announces-real-time-release-complete-response-letters-posts-previously-unpublished-batch-89. Accessed September 8, 2025.

[8] Lurie P, Chahal HS, Sigelman DW, et al. Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: cross sectional study. BMJ. 2015;350:h2758. https://www.bmj.com/content/bmj/350/bmj.h2758.full.pdf. Accessed August 27, 2025.

[9] Ibid.

[10] Swetlitz I. Gottlieb changes course on FDA publication of rejection letters. January 16, 2018. STAT. https://www.statnews.com/2018/01/16/gottlieb-fda-response-letters/. Accessed August 27, 2025.

[11] European Medicines Agency. What EMA publishes and when. https://www.ema.europa.eu/en/documents/other/guide-information-human-medicines-evaluated-european-medicines-agency-what-agency-publishes-when_en.pdf. Accessed August 27, 2025.

[12] Steinbrook R. The FDA and ‘confidential commercial information.’ Worst Pills, Best Pills News. December 2024. https://www.worstpills.org/newsletters/view/1632. Accessed August 27, 2025.

[13] Daval CJR. The origins of “confidential commercial information” at the FDA. JAMA 2024;332(7):533-34. https://jamanetwork.com/journals/jama/fullarticle/2821289. Accessed August 1, 2025.