Bradley Merrill Thompson, a Member of the Health Care and Life Sciences practice in the Washington, DC, office, was quoted in “Court Again Vacates FDA Combination Product Classification for Prevor Skin Wash.”
Following is an excerpt:
Attorney Bradley Merrill Thompson, of Epstein Becker & Green PC's Washington office, told Bloomberg BNA Sept. 12 that “the decision is amazing.”
“Given the deference that courts are called upon to give agencies, it is highly unusual for a court to reverse an agency decision once, let alone twice,” he said. “The judge, rightfully so, is insisting that the agency ground its actions in the very specific language of the statute.”
“Among the takeaways for FDA is that it needs to do a more thorough job of explaining its decisions,” Thompson said. “This litigation started, at least in part, because the agency was fairly cryptic in its explanation for why this product should be regulated as a combination product with a drug primary mode of action.”
