HOME  |  CONTACT US  |  SUBSCRIBE  |  SUPPORT WLF

Case Detail


Prevor v. Food and Drug Administration
On September 9, 2014, the U.S. District Court for the District of Columbia issued a ruling that prevents the Food and Administration (FDA) from adopting new product classification rules that could cause numerous medical products previously classified as devices to be reclassified as drugs. The decision was a victory for WLF; WLF argued in a brief it filed in the case (and the court agreed) that the new classification rules conflict with the federal statute that defines what constitutes a “device.” The case was a challenge to FDA’s decision to regulate a new skin wash as a drug, even though similar products have previously been regulated as medical devices. This marked the second occasion on which FDA had sought to classify the product as a drug. A federal court overturned both of FDA classification decisions, deeming them “arbitrary and capricious.” WLF argued that FDA must go to Congress if it wants to expand the definition of a “drug.”
Case Status:
Victory. Monitoring for FDA actions on remand.
More Information and Downloads:
1/24/2014: Download the Brief

  • Welcome to the Washington Legal Foundation
  • 2009 Massachusetts Ave., NW
    Washington, DC 20036
  • info@wlf.org  |  ph. 202-588-0302
    ©2017 WLF All Rights Reserved