Temkin and Elwood Featured in RAPS on Chevron’s Challenge to FDA Authority
John Elwood, head of the firm’s Appellate and Supreme Court practice, and Eva Temkin, Life Sciences & Healthcare Regulatory partner, were recently featured in the Regulatory Affairs Professionals Society (RAPS) article, “Experts: Chevron deference ruling could impact recent FDA regulations.” Elwood and Temkin shared their thoughts on whether the U.S. Supreme Court’s decision to overturn the Chevron doctrine could be used to challenge the U.S. Food and Drug Administration’s (FDA) authority, particularly concerning the administration’s recent decision to regulate laboratory-developed tests (LDTs).
Temkin told RAPS that she believes “courts will still look to FDA scientific decision-making and that will still be a place where FDA enjoys considerable discretion.” She noted, however, that the FDA “is going to have to take a really hard look at the way that it goes about making decisions on questions of statutory interpretation, and I recognize that it can be very difficult to disaggregate questions of statutory interpretation from questions of science and the FDA regulated landscape.”
Elwood agreed and added that “this is a big opinion, but it is only involving whether you can confer deference from ambiguity, but there's still a lot left to agency decision-making. There are still areas where agencies are going to get deference... Areas where agencies have expertise and it's clear that Congress has set up a mechanism that counts on agency expertise like drug approvals.”
