Drugs

FDA Publishes Complete Response Letters

FDA says it is demonstrating “radical transparency” with the publication of over 200 complete response letters (CRLs) issued between 2020 and 2024. The letters were issued in response to applications for approval of new drugs or biologics.

An agency statement (contains a link to the letters) says the public “now has significantly greater insight into FDA’s decision-making and the most common deficiencies cited that sponsors must address before their application is approved.”

FDA issues CRLs for a number of reasons, the statement says, most related to safety and efficacy concerns. The letters may also include agency recommendations for addressing the concerns.

“For far too long, drug developers have been playing a guessing game when navigating FDA,” says commissioner Martin Makary. “Drug developers and capital markets alike want predictability. So today we’re one step closer to delivering it to them, with an ultimate goal of bringing cures and meaningful treatments to patients faster.”

The statement says that because CRLs historically have not been published, sponsors have often misrepresented the rationale behind an FDA decision to their stakeholders and the public. It cites a 2015 analysis by agency researchers that found that sponsors avoided mentioning 85% of FDA’s concerns about safety and efficacy when announcing publicly that their application was not approved. Also, it says, when FDA called for a new clinical trial for safety or efficacy, that information was not disclosed about 40% of the time. “Lessons learned from non-approvals are also not shared with the industry,” FDA says, “leading companies to repeatedly make similar mistakes.”

FDA says the published CRLs were redacted for trade secrets and confidential information.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome