This morning, the U.S. Food and Drug Administration (FDA) announced the publication of more than 200 decision letters, also known as complete response letters (CRLs), with plans to release more from the archives. The CRLs released today are associated with applications for drugs and biologics submitted for approval between 2020 and 2024 that have since been approved by the agency.
In the accompanying press release, FDA Commissioner Marty Makary, M.D., M.P.H., stated that drug developers have been “playing a guessing game when navigating the FDA…” and that “[d]rug developers and capital markets alike want predictability.” He indicated that the publication of these CRLs will help the agency to provide both parties with greater visibility into the agency’s processes, noting that this will hopefully bring “cures and meaningful treatments to patients faster.” The press release goes on to note that sponsors have “often misrepresent[ed] the rationale behind FDA’s decision to their stakeholders and the public.” In particular, “[a]ccording to a 2015 analysis conducted by FDA researchers, sponsors avoided mentioning 85% of the FDA’s concerns about safety and efficacy when announcing publicly that their application was not approved… [and that] when FDA calls for a new clinical trial for safety or efficacy, that critical information is not disclosed approximately 40% of the time.”
The release of negative decision letters to improve transparency is not a new idea. In fact, FDA’s campaign to release CRLs goes back more than 15 years, including the 2010 report released by FDA’s Transparency Task Force that proposed the disclosure of CRLs. As the press release alludes to, FDA resources will be implicated in reviewing these letters for the redaction of confidential and trade secret information.
Novel idea or not, today’s announcement will mean that companies will need to consider the implications of a CRL being released, both with regard to their investors and the public. It is possible that this will lead to more application withdrawals and may even hinder innovation in these areas. In turn, product developers, investors and others will potentially have greater insights into FDA’s expectations for particular types of drugs and biologics.