Eva Temkin Discusses FDA’s Complete Response Letter Transparency Policy in BioSpace
Eva Temkin, Arnold & Porter Life Sciences & Healthcare Regulatory partner and former Acting Policy Staff Director at the U.S. Food and Drug Administration (FDA)'s Office of Therapeutic Biologics and Biosimilars, was quoted in the BioSpace article, "FDA's radical transparency policy for rejections runs into legal uncertainty," which examines the legal and regulatory questions surrounding the FDA's policy of publishing complete response letters (CRLs) for unapproved drug applications.
Addressing the FDA's current approach, Eva cautioned that the agency's policy shift raises complex legal and regulatory issues that have not been adequately vetted through the public rulemaking process. "I'm not sure the new policy is right," she said, explaining that the change "was premised on a very narrow view of the way this policy would impact drug development and, hence, patient access."
Eva also welcomed the FDA's decision to pursue formal rulemaking, noting that stakeholders should have the opportunity to provide meaningful input before the policy moves forward. While observing that "it's likely too late to put the proverbial toothpaste back in the tube," she urged the agency to pause implementation of the CRL publication policy until it "receives feedback, considers that feedback and finalizes the rule accordingly."
