FDA Publishes Over 200 Complete Response Letters in Bid for Transparency

The FDA published over 200 decision letters, or complete response letters (CRLs), in an attempt to “modernize and increase transparency” within the agency.

The CRLs in question were “issued in response to applications submitted to the FDA for approval of drugs or biological products between 2020 and 2024.” The FDA touts this act as giving the public “significantly greater insight into the FDA’s decision-making and the most common deficiencies cited that sponsors must address before their application is approved.”

CRLs are “issued directly to product sponsors when the FDA completes its review cycle and determines that it cannot grant an approval of an application in its current form. The FDA issues CRLs for various reasons, most related to safety and efficacy concerns, manufacturing deficiencies, and bioequivalence issues.”

The FDA writes in the statement that “sponsors often misrepresent the rationale behind FDA’s decision” when not presented with a CRL. According to a 2015 analysis 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. Moreover, when FDA calls for a new clinical trial for safety or efficacy, that critical information is not disclosed approximately 40% of the time.”

The initial batch of published decision letters “is now accessible to the public at openFDA.”