Bradley Merrill Thompson Quoted in Article, “Judge Vacates Finding That Prevor Skin Wash Is Drug, Not Device, Sends Case Back to FDA”Bloomberg BNA September 26, 2012
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Judge Vacates Finding That Prevor Skin Wash Is Drug, Not Device, Sends Case Back to FDA."
Following is an excerpt:
French company Prevor scored a big victory Sept. 25 after a federal court found the Food and Drug Administration's action classifying its Diphoterine Skin Wash (DSW) product as a drug rather than a device was arbitrary and capricious (Prevor v. FDA, D.D.C., No. 1:11-cv-01187-RMC, 9/25/12).
Bradley Merrill Thompson, with Epstein Becker & Green PC in Washington, told BNA Sept. 26, "The broader lesson to be taken from this court case is that FDA is expected to provide not just a global basis for its decision, but a more reasoned, nuanced and specific explanation. And that will be a good thing."
"Further," he said, "the court did seem to emphasize the need for careful consideration of past precedent. For an industry that very much wants predictability in the regulatory system, emphasis on past precedent is a welcome thing."