The next time the FDA turns down a drug application, the letter outlining the decision and the regulator’s reasoning will become public record. The agency said it will release future complete response letters (CRLs) “promptly after they are issued to sponsors.”
The Thursday announcement follows the FDA’s July move to publish more than 200 letters from 2000 to 2024 as part of its pledge for greater transparency. Along with pledging to publish all CRLs going forward, the FDA said in its latest announcement that 89 previously unpublished letters issued from 2024 to the present have been published. The agency said each letter details specific safety and efficacy deficiencies that prevented an FDA approval.
Companies have generally opposed publishing of CRLs. Besides not wanting a public airing of bad news about their drugs, they also do not want proprietary information disclosed. The FDA said published letters will be redacted to remove confidential commercial information, trade secrets, and personal private information. But company names will be made public.
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There’s more. When the FDA approves a drug, it will also release all CRLs associated with that drug’s application. The agency said it will also publish batches of previously issued CRLs associated with drug applications that were withdrawn or abandoned. The agency said publishing the letters benefits the public and industry. Information about what happened to a drug helps other companies avoid the same missteps while also providing insights for patients and their physicians. The FDA added that the investment community also benefits from information about a drug in the proper context.
“By embracing radical transparency — one of the guiding principles of this administration — we’re giving invaluable insights to help speed therapies and cures to market, providing complete context to investors and shareholders, and above all, restoring public trust,” FDA Commissioner Marty Makary said in the FDA announcement.
The CRL announcement comes two weeks after the FDA announced that new reports to the FDA Adverse Event Reporting System (FAERS) would be published daily. The database — a repository of drug and vaccine complications reported by the members of the public, physicians, and product manufacturers — was previously updated on a quarterly basis.
In the July announcement, Makary said people should not have to wait months for adverse event reports to become public. He called the change part of the FDA’s data modernization strategy. It’s important to note that adverse event reports in FAERS have not been vetted and a report of a complication listed in the database does not definitively mean a drug or vaccine was the cause.
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The FDA’s CRL announcement said publication of the letters complies with an executive order issued by President Trump in May for “restoring gold standard science.” In a section regarding the communication of scientific data, the order directs agencies to release “data, analyses, and conclusions associated with scientific and technological information produced or used by the agency that the agency reasonably assesses will have a clear and substantial and substantial effect on important public policies or important private sector decisions (influential scientific information), including data cited in peer-review literature.”
The CRL database may be freely accessed here.
Photo: Tom Williams/CQ-Roll Call, Inc, via Getty Images