In a single response to a request from one company in 2009, and then subsequently in 2011 through a draft guidance document, the Food & Drug Administration (FDA) is sweeping aside decades of agency practice on how it determines what is a “medical device” and what is a “drug.” The distinction is a critical one for health product companies, as the drug approval process in generally far lengthier and more expensive than the device process. Equally or more important, however, is that FDA’s decision-making approach evaded public and legislative accountability.
FDA’s Way or the Highway: Its Unlawful Alteration of “Device” Definition
WLF Legal Pulse
The statutory definitions of “drug” and “device” are very similar, with one provision in the law providing the key difference – it’s a device if the product “does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and . . . is not dependent upon being metabolized for the achievement of its primary intended purposes.”
In 2009, Prevor, a company which produces products that address chemical risks and exposure, asked FDA to categorize its Diphoterine® Skin Wash (DSW) as a device. DSW’s “primary intended purpose” is to protect workers from toxic chemicals by displacing the chemicals from skin following an accidental spill. That is done through propelled liquid. The liquid contains 4% diphoterine, which can help neutralize some chemical agents on the skin. Prevor’s studies showed that this feature accounted for 10% of its therapeutic value. In its response in which it categorized DSW a “drug,” FDA wrote that this 10% was enough to indicate that DSW works, “at least in part” through chemical action.
Just like that, with a whisk of its bureaucratic wand, FDA redefined both the terms “primary intended purposes” and “device.” In June 2011, Prevor filed suit against FDA, alleging its decision violated the Administrative Procedures Act (APA). That same month, through a series of draft guidances, FDA confirmed this entirely new, completely out-of-the-blue interpretation of “primary intended purposes.” As WLF’s comments to FDA on the guidance noted, “FDA is declaring, without providing any reason or explanation, that all of the ‘intended purposes’ of a product are “primary.”
Such manipulation of commonly understood words is so brazen that it would knock Through the Looking Glass‘s Humpty Dumpty (who famously uttered that a word “means just what I choose it to mean”) off of his wall.
FDA’s ruling on DSW and its guidance documents have inspired justified alarm in the drug and device industries. How many products that are currently “devices” could be retroactively categorized as “drugs”? How many products that are currently in FDA’s device process, or being developed as a “device” and not a “drug,” be affected by the new definition of “primary”?
Prevor and FDA have both moved for summary judgment in Prevor’s suit. Last week, WLF filed an amicus brief supporting Prevor’s motion. We argue that the court should find FDA’s policy shift on device vs. drug as “legislative” or “substantive” in character, and thus require FDA to follow the formal requirements of the APA. One court recently put a halt to similar attempts to avoid accountability through “guidance,” as detailed in a WLF Legal Backgrounder. We hope for the same result here.