A federal court has again ruled against the FDA’s definition of what constitutes a "medical device" versus a "drug" in a long-running case involving a market application submitted by France’s Prevor for its industrial skin-cleaner DSW.
Last month, the U.S. District Court for the District of Columbia rejected for a 2nd time the FDA’s classification of DSW as a drug, remanding the matter again to the agency for further action.
At issue has been whether DSW, formally known as Diphoterine Skin Wash, is primarily a drug or a device. The product, which is used to help prevent chemical burns in industrial workplaces, is sprayed onto the skin via a cannister. Prevor has argued that the product is primarily a device, as it used to wash skin, which is a mechanical action. The FDA has countered that the product is a drug because it uses chemicals to neutralize other compounds.
Prevor first filed to have the product classified as a device in 2009. In 2011, the agency determined the product was a drug, prompting a suit by Prevor.
In September 2012, the D.C. district court rejected the FDA’s interpretation of the Federal Food, Drug & Cosmetic Act, remanding the matter to the agency. In May 2013, the agency again classified DSW as a drug, prompting Prevor to refile its suit.
In its most recent decision, the court has again remanded the matter to the agency, noting that "FDA hardly changed its reading of the statute and relied on an arbitrary standard that contravenes the plain meaning of the law." The court also admonished the agency for acting "arbitrarily and capriciously in violation of the Administrative Procedure Act."