The FDA has published over 200 complete response letters issued between 2020 and 2024. These letters are sent to drug sponsors when the FDA determines that an application cannot be approved in its current form, often because of concerns related to safety, efficacy, manufacturing, or bioequivalence.
Historically, the letters were not publicly disclosed, allowing companies to share information selectively, which sometimes led to misrepresentation of the FDA's concerns. A 2015 FDA analysis revealed that sponsors omitted 85 percent of safety and efficacy issues in public disclosures. By making these redacted letters available, the FDA aims to provide greater insight into its decision-making process, promote industry learning, and prevent repeated mistakes.
The agency says it has ensured that all published letters have been redacted to protect trade secrets and confidential commercial information. FDA Commissioner Marty Makary emphasized the importance of this transparency initiative, stating that it will help stakeholders better understand the FDA's decision-making processes. In a LinkedIn announcement, Makary emphasized that this move aims to eliminate "guessing games" with the aim of enabling developers, investors, and patients to understand the FDA's decision-making processes more transparently. The post has attracted significant discussion. Tom Schulz, a cell and gene therapy executive at the University of Adlaide, described the development as "excellent", while Janet Chung, a former director of external manufacturing at Regeneron, called it “a great step forward”. Ismet Ince, CEO of Inpharmus, described the announcement as “ towards efficient allocation of limited resources to the right projects. This is an area we need disruption as an industry”.
However, some, like Todd Bourcier, Co-Founder, White Oak Regulatory Tox, questioned the scope of the release, pointing out the apparent exclusion of 505(b)(1) New Drug Applications from the published CRLs.
Speaking to TMM, Audrey Greenberg, Mayo Clinic Venture Partner and AG Capital Advisers CEO, said: “This is one of the most important regulatory moments in recent memory, and the implications are broad and mostly positive. This is a smart and long-awaited step by the FDA and one that finally brings biopharma regulation in line with the public accountability frameworks that have existed in finance, IP, and environmental review for decades. Radical transparency won’t fix every broken incentive in drug development, but it might finally help us stop making the same costly, preventable mistakes.”
Nobody ever expected the reformed FDA to get everything right, but they were expected to learn lessons from the past – and it looks like that’s happening. Let me know what you think: rob.coker@conexiant.com
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