After pausing a controversial policy to publicly release drug rejection letters in April, the FDA today confirmed that the pause has been lifted and that more documents will be coming down the line.
A spokesperson for the Department of Health and Human Services told Fierce last week that the policy to release complete response letters (CRLs) in real-time had been temporarily suspended in April, the first time the pause was confirmed. Mere days later, the agency dropped a new batch of 14 CRLs, raising questions about the policy’s status.
“FDA will continue to proactively publish appropriately redacted CRLs, building on the batch released on July 10,” the spokesperson told Fierce today.
Redaction was a key issue that sparked backlash to the policy from the industry, with an unnamed pharma company issuing a citizen petition against the “radical transparency” in April due to the disclosure of sensitive information.
In the petition, law firm Covington & Burling wrote on behalf of the undisclosed pharma that the CRL policy goes against federal statutes meant to protect confidential information and can result in “competitive harm” for drugmakers.
“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.
Since hitting the brakes on CRL release in April, the FDA “has been working across the agency to strengthen and formalize its internal processes for reviewing, redacting and publishing CRLs,” the HHS spokesperson told Fierce.
“FDA routinely considers public input, legal requirements and feedback from stakeholders when evaluating opportunities to improve its processes,” the spokesperson added, and the regulator will “continue refining its approach” to ensure that CRLs are not published with unredacted trade secrets or other confidential information.
The release of CRLs was a key initiative of former FDA Commissioner Marty Makary, M.D., who previously asked Congress to formalize the policy before his May departure from the agency. The FDA has now proposed a rule to formally grant the commissioner the power to release CRLs.