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Reining in FDA’s “Expansive Language” and “Doubly Grandiose” Interpretations of Chemical Action

Randy Prebula

04 October 2012
When the Food and Drug Administration (“FDA” or the “agency”) issued two draft guidances regarding the definition of “chemical action” and how it would relate to product designations under the FDC Act in June 2011, we argued in an FDLI Update article that the agency’s interpretation of the statute and guidances could “provide FDA with greatly expanded flexibility and potentially overbroad discretion” and that FDA’s “departure from precedent” could have unanticipated consequences for legally marketed medical devices.  Briefly, the agency’s guidances, here and here, were based, we argued, on an extremely expansive view as to how “any chemical action” or products that depend “at least in part” on chemical action to achieve any purpose, could be regulated as drugs, not as devices.  In discussions with FDA’s Office of Combination Products, we have seen the agency apply the expansive interpretation approach and deviate from precedent for seemingly identical products.

Certainly, in seeking to balance FDA’s ability to achieve the agency’s “overriding purpose to protect the public health” (United States v. Bacto-Unidisk, 394 U.S. 784 (1969)) against the requirement that FDA not act arbitrarily or capriciously in interpreting the FDC Act, the agency should be afforded some reasonable degree of discretion.  On September 25, 2012, Judge Rosemary Collyer of the United States District Court for Washington, DC, issued an opinion that addressed the specific issue of “chemical action” and how products should be designated by FDA with these counterbalancing principles in mind.

Briefly, the case (Prevor v. FDA, Civil Action No. 11-1187 (RMC)) involved a chemical solution, referred to as “DSW,” that could be sprayed onto the body to remove and inactivate chemicals resulting from chemical spills.  FDA argued that the ability of the solution to bind to the chemicals so that they could not interact with the body was enough for the product to be regulated as a drug.   Judge Collyer’s September 25, 2012, opinion found that

"FDA’s reliance on extraordinarily expansive language ('at least in part' or 'even in part') demonstrates the agency’s own recognition that without such an interpretation of 'primary intended purpose,' DSW could be designated a 'device.' and that “The agency’s ipse dixit cannot substitute for the 'qualitative analysis' or 'scientific information' on which FDA says it acted, and the Court can find none in its classification letters or in the Administrative Record."

Although not directly addressing APA arguments about FDA's guidances in this area, the opinion also takes FDA to task for changing its interpretation of what constitutes chemical action and a product’s primary mode of action or primary intended effect, without explanation or reason.  Judge Collyer cited FDA specifically for applying "a doubly-grandiose interpretation of the phrase 'primary intended purposes' from 21 U.S.C. § 321(h)," and in ignoring prior regulatory decisions and precedents. The court then remanded the Prevor DSW designation back to the agency for further consideration consistent with the court’s opinion and analysis.

As this and other products proceed through FDA’s regulatory designation process, we and others will be monitoring the agency’s response.  Many fear that OCP will simply ignore or try to find a way around this ruling by limiting its applicability.  Many questions remain open: Will the definitions of primary intended purposes and primary mode of action be applied meaningfully and with consistency?  Will FDA revise its guidance documents in this area? Will FDA seek to document more thoroughly, qualitatively, and scientifically the agency’s reasoning?  Will more companies now challenge OCP’ rulings in this area?  Given the potential impact on new and existing products, their regulatory paths, whether virtually identical products may be treated dissimilarly, and to what extent product-specific precedents are meaningful, this is an area that will bear careful scrutiny through the coming year.

Randy Prebula

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