WLF Seeks to Overturn “Do Over” FDA Ruling
Prevor v. Food and Drug Administration
WASHINGTON, DC.— The Washington Legal Foundation (WLF) this week urged the U.S. District Court for the District of Columbia to prevent 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. In a brief filed in Prevor v. FDA, WLF argued that the new classification rules conflict with the federal statute that defines what constitutes a “device.” The case is a challenge to FDA’s decision to regulate Diphoterine® Skin Wash (“DSW”) as a drug—even though similar products have previously been regulated as medical devices. The dividing line between a “device” and a “drug” can sometimes be difficult to discern. In general, manufacturers would prefer to have their products classified as “devices,” a classification that often makes it easier for them to obtain marketing clearance from FDA. Federal law provides that a medical product qualifies as a device only if it “does not achieve its primary intended purposes through chemical action within or on the body of man or other animals.” If it does achieve its “primary intended purposes” through chemical action, then it is classified as a drug. DSW, which is applied to the skin to prevent chemical burns, accomplishes one of its intended purposes through a chemical action; the issue is whether that purpose constitutes a “primary” intended purpose. FDA recently sought to expand the definition of “drug” in order to increase the number of products that would be subject to the more rigorous product testing requirements applicable to drugs. Applying its expanded definition, FDA ruled in 2009 that DSW was a drug. The district court held in 2012 that FDA acted arbitrarily and capriciously in making that classification; it ordered FDA to reconsider and to provide a full explanation of its decision. FDA responded by adopting yet another new standard for differentiating drugs and devices, and it used the new standard to once again classify DSW as a drug. WLF’s brief argues that FDA once again acted arbitrarily and capriciously and is ignoring its statutory mandate. After filing its brief, WLF issued the following statement by Chief Counsel Richard Samp: “FDA needs to stop making up the law as it goes along. It is required to provide a reasoned explanation when it decides to reverse its policies. And if it is unhappy with the law as written, it needs to ask Congress to amend the law, not simply ignore it. The law gives FDA 60 days to classify a product; it has now delayed nearly five years yet still has not issued a valid decision.” WLF is a public interest law firm and policy center that regularly litigates in support of patients who seek expedited access to life-saving medical products.