Embrace transparency, the FDA will make all future drug rejection letters public
The next time the FDA rejects a drug application, the letter outlining the decision, and the regulator’s reasoning will become a public record. The agency said it will issue a complete future response letter (CRLS) “issued immediately after it is sent to sponsors.”
Thursday's announcement comes after the FDA released more than 200 letters from 2000 to 2024 held in July, as part of its commitment to increase transparency. In its latest announcement, the FDA said it has published 89 previously unpublished letters, from 2024 to the present, in addition to guaranteeing the release of all CRLs. Each letter details specific safety and efficacy deficiencies that prevent FDA approval, the agency said.
Companies generally object to publishing CRLs. Apart from not wanting bad news about their drugs to be aired publicly, they don’t want to disclose proprietary information. The FDA said the published letters will be deleted to remove confidential business information, trade secrets and personal private information. But the company name will be published.
And more. When the FDA approves the drug, it will also release all CRLs associated with the use of the drug. The agency said it will also issue previously issued CRLs related to withdrawn or abandoned drug applications. The agency said posting letters is beneficial to the public and the industry. Information about what happens to the drug can help other companies avoid the same mistakes, while also providing insights to patients and their doctors. The FDA added that the investment community can also benefit from information about the drug when appropriate.
“By adopting fundamental transparency (one of the guiding principles of this administration), we will provide valuable insights to help accelerate the therapeutic and therapeutic markets, thus providing a complete background for investors and shareholders, especially to restore public trust,” FDA Commissioner Marty Makary said in the FDA announcement.
The CRL announcement was released for two weeks after the FDA announced a new report to the FDA Adverse Event Reporting System (FAERS) every day. The database is a repository of drug and vaccine complications reported by the public, physicians and product manufacturers – previously updated quarterly.
In a July announcement, Makary said people don’t have to wait for months to make the adverse event report public. He called the change part of the FDA's data modernization strategy. It is important to note that adverse event reports in the Forecast have not been reviewed and that reports of complications listed in the database do not explicitly mean that the drug or vaccine is the cause.
The FDA's CRL announcement said the publication of the letters was in line with President Trump's executive order to “restore gold standard science” in May. In the section on the dissemination of scientific data, the order directs the agency to publish “data, analysis and conclusions related to scientific and technical information generated or used by the agency, which reasonably evaluates will be made on important public policies or important private sector decisions (influential scientific information) (including data cited by the data), including the Peer-Reer-Reer-Reer-Review literature.”
The CRL database is freely accessible here.
Photo: Tom Williams/CQ-Roll Call, Inc, via Getty Images
