The FDA’s new practice of releasing redacted complete response letters (CRLs) in the name of “radical transparency” is ruffling some feathers in the drug industry, as illustrated through a new petition filed on behalf of an unnamed pharma.
The citizen petition, filed by Washington, D.C.-based law firm Covington & Burling on behalf of an “individual pharmaceutical company,” calls on the FDA to tighten up its structure for disclosing drug rejection letters and to allow the related drugmakers more involvement in the process.
The action comes in response to the agency’s new posture toward its release of CRLs, which took a turn last summer as part of the FDA’s ongoing efforts to boost transparency throughout the drug regulation process.
Previously, the FDA had protected the privacy of the rejection letters sent to companies, with most publicly available letters coming out through Freedom of Information Act (FOIA) requests or voluntary disclosures.
In now making the CRLs publicly available, the agency hopes to help other drugmakers avoid “playing a guessing game when navigating the FDA,” agency commissioner Marty Makary, M.D., has said.
Since then, the agency has released rejection letters in large batches, redacting certain trade secrets and other confidential information, and it has made an effort to post CRLs quickly after rejections.
This practice, as Covington writes, goes against several federal statutes meant to protect confidential information and can result in “competitive harm” for drugmakers. Moreover, disclosing rejection letters for unapproved drug applications can “mislead the public” and cause “unjustified concerns” about a product’s safety and effectiveness if ultimately approved, the petition notes.
Given the “significant legal and public policy issues at stake,” the citizen petition asks that the FDA take proper steps to redact all confidential commercial information from its rejection letters before public release and to make sure that drugmakers have the chance to engage with the agency on such redactions.
“Creating a mechanism for manufacturers to provide input on redactions before posting of CRLs would protect both current and future applicants affected by this interpretational change that was made without any opportunity for notice or comment,” the attorneys explained.
The petition goes on to list several specific incidences of unredacted material information revealed through the agency’s release of 127 public CRLs for unapproved drug applications, including rejections for Lykos Therapeutics, Stealth BioTherapeutics and more. According to the filing, in at least 61 of the public CRLs, the fact that a rejection was issued was not public at the time and in at least 36, the applications that the CRL responded to had not been publicly disclosed or acknowledged.
The CRL callout comes a few weeks after Makary voiced his desire for the FDA to have the explicit authority to publicly disclose “certain information” related to deficiencies in safety and efficacy data outlined in the CRLs, which could “make drug development more efficient for multiple stakeholders,” he explained in his fiscal year 2027 policy wish list (PDF) to Congress.