What High Court's Kisor Ruling Means For FDA Decisions

Law360 (July 16, 2019, 4:34 PM EDT) -- On June 26, 2019, the U.S. Supreme Court issued its opinion in Kisor v. Wilkie, refusing to overturn a longstanding doctrine of deferring to administrative agencies’ interpretation of their own regulations.[1]

The case was on appeal from the U.S. Court of Appeals for the Federal Circuit and raised the question of whether the Supreme Court should overturn the Auer deference doctrine stemming from the Auer v. Robbins and Bowles v. Seminole Rock & Sand Co. decisions. Auer deference provides that an agency’s interpretation of its own regulations is controlling unless the interpretation is erroneous or inconsistent with the regulations being interpreted.[2]...

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