The FDA’s new approach to releasing redacted Complete Response Letters (CRLs) in the name of “radical transparency” is causing ripples in some parts of the pharmaceutical industry, as evidenced by a new petition filed on behalf of an anonymous drug company.
The citizen petition, filed by the Washington, D.C.-based law firm Covington & Burling on behalf of “private drug companies,” asks the FDA to strengthen its disclosure of drug rejection letters and allow the drug companies involved to be more involved in the process.
The action is in response to the agency’s new stance on publishing CRLs, which reversed course last summer as part of FDA’s continued efforts to increase transparency throughout the drug regulatory process.
Until now, the FDA has protected the privacy of denial letters sent to companies, with most of the letters released publicly through Freedom of Information Act (FOIA) requests or voluntary disclosures.
By publishing the CRL now, the FDA hopes to help other drug companies avoid “playing guessing games during the FDA process,” said Dr. Marty McCully, the agency’s commissioner.
Since then, the agency has released a large number of denial letters redacting certain trade secrets and other sensitive information and has worked to post CRLs quickly after denials.
As Covington writes, this practice violates several federal regulations designed to protect sensitive information and could result in “competitive harm” to drug companies. Additionally, the petition notes that disclosure of rejection notices for unapproved drug applications could “mislead the public” and raise “unwarranted concerns” about the safety and effectiveness of the product if ultimately approved.
Given that “significant legal and public policy issues are at stake,” the citizen petition urges FDA to take appropriate steps to redact all commercially sensitive information contained in rejection letters prior to publication, and to ensure that drug companies have an opportunity to engage with FDA regarding such redactions.
“Creating a mechanism for manufacturers to provide input on edits before posting a CRL would protect both current and future applicants affected by this interpretive change, which was made without notice or opportunity for comment,” the attorneys explained.
The petition goes on to list several specific instances of unredacted critical information revealed through the agency’s release of 127 public CRLs for unapproved drug applications, including denials of Lykos Therapeutics, Stealth BioTherapeutics, and others. According to the filing, in at least 61 of the published CRLs, the fact that a decision of refusal had been issued was not made public, and in at least 36 cases, the applications the CRL responded to were neither published nor acknowledged.
The CRL’s call comes weeks after McCurry expressed a desire for the FDA to be given clear authority to publicly disclose “certain information” related to deficiencies in the safety and efficacy data outlined in the CRL, as explained in his FY27 Policy Request List (PDF) to Congress. That could “make drug development more efficient for multiple stakeholders,” McCurry explained.
