Drugs

FDA Restarts Complete Response Letter Postings

FDA has resumed posting complete response letters (CRLs) just days after HHS confirmed that new rejection letter releases had been halted temporarily (see story) while the agency reviewed legal and policy concerns surrounding its controversial transparency initiative. The CRL postings, which were launched under former FDA commissioner Marty Makary as part of a broader “radical transparency” effort, are intended to provide drug developers, investors and the public with greater insight into FDA decisions. As of 7/10, 14 new letters have been posted here.

The agency had argued that broader disclosure would help companies better understand regulatory expectations and avoid repeating development mistakes. he move represented a significant departure from longstanding FDA practice. Historically, CRLs generally have not been publicly disclosed when they involve unapproved products because they may contain confidential commercial information, including details from pending applications.

The transparency initiative quickly drew criticism from industry attorneys and regulatory experts, who questioned whether FDA had sufficient legal authority to release the letters before products were approved and whether sponsors should have an opportunity to review and redact confidential information before publication.

FDA’s temporary pause followed an April citizen petition from Covington & Burling that was submitted on behalf of an unnamed pharmaceutical company challenging the agency's authority and implementation of the transparency initiative.

Despite the resumption of CRL postings, FDA is also moving ahead with plans to formalize the policy through notice-and-comment rulemaking. An agency-planned rulemaking listed in the recent unified agenda as “Proactive Disclosure of Complete Response Letters” would amend FDA regulations governing the confidentiality and disclosure of regulatory correspondence and establish a formal framework for releasing redacted CRLs. It is scheduled for publication as a proposed rule in October.

According to the agency, current regulations already provide substantial discretion to release information contained in CRLs and make clear that FDA's analyses and deliberations reflected in the letters are not the property of the application sponsor. The proposed rule would remove what FDA characterizes as the principal regulatory obstacle to broader disclosure — the assumption that the existence of a previously undisclosed application is itself confidential commercial information.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome