Whether the FDA considers a product to be a “medical device” as opposed to a “drug” has very important implications. Manufacturers of devices face less burdensome regulation and far cheaper application fees. A long-litigated case, Prevor v. FDA (Prevor II), highlights the gravity of FDA’s decision with regards to combination products. After five years in court, Prevor and the FDA continue to dispute whether Prevor’s Diphoterine Skin Wash (DSW) should be regulated as a medical device—Prevor’s preference—or a drug. Most recently, FDA argued that DSW meets the drug definition because chemical action “meaningfully contributes” to DSW’s intended purpose. The court struck down this argument, marking a win for industry, but refused to go all the way towards considering DSW a device.
DSW was developed to prevent and minimize chemical burn injuries that occur in industrial workplaces due to accidental exposure to chemicals. Specifically, the product is used by “spraying the pressurized contents of the canister on to the skin to physically and mechanically remove splashes of acids and bases off the skin by washing them away.” In August 2009, Prevor submitted a Request for Designation (RFD) to FDA’s Office of Combination Products (OCP) recommending that DSW be classified as a device, regulated by the Center for Devices and Radiological Health. OCP instead classified DSW as a combination product, and, finding that the liquid substance inside the canister “achieves its intended purposes, at least in part, through chemical action, it does not meet the definition of device.” OCP sent DSW to the Center for Drug Evaluation and Research (CDER) for review and regulation as a drug. Prevor disagreed.
A chart best illustrates the issues at hand in considering whether a given combination product is classified as a drug or device. Note that the determination hinges on the exclusionary language in the device column.
Prevor I
In the initial case before the court, Prevor and FDA sparred over DSW’s “primary intended purpose”—was it the device’s power to physically displace chemicals, or the neutralizing chemical effect? Prevor claimed that DSW’s first use was the product’s ability to displace the chemicals. Prevor contended that the physical action comprised 90% of the product’s overall effect, whereas the neutralizing chemical effect comprised about 10% of the overall effect. FDA built their case on the importance of the product’s chemical neutralization. For example, FDA considered the difference between DSW and emergency showers, noting the additional significance of chemical action in DSW, given that it had to compensate for less force and volume. Moreover, while the recommended intervention time after chemical exposure for emergency showers is within 10 seconds, the recommended treatment time for DSW is within 60 seconds.
FDA interpreted the product’s “primary intended purpose” in a way that relied on “extraordinarily expansive language,” according to the court. Indeed FDA contended: “[I]f an article depends, even in part, on chemical action within or on the body to achieve any of its primary intended purposes, it does not meet the definition of a device.” The Prevor I court found this interpretation to be inconsistent with the statute. “Inasmuch as the statute seeks to identify primary intended purposes that are achieved through chemical action, it would be significantly expanded if a primary purpose could automatically be achieved ‘at least in part’ or ‘even in part’ by chemical action,” stated the court. “There may be solid scientific reasons for FDA’s new approach but these remain unexplained, at least without defining ‘primary’ in a manner consistent with the law.” Thus, the court remanded the case for that purpose.
Prevor II
In Prevor I, the court found that FDA adopted too broad a definition of “primary intended purpose,” as opposed to secondary purpose. In the second round, FDA again classified DSW as a drug-device combination product that should be regulated as a drug. Instead of narrowing their definition of “primary intended purpose,” however, FDA adopted an entirely new strategy. FDA initially determined that DSW had two primary intended purposes: “to wash the chemical off the skin and neutralize the chemical that is on the skin.” On remand, FDA found a single primary purpose: “to help prevent and minimize accidental chemical burn injuries.” The court noted that “[i]n selecting one purpose alone, FDA conveniently avoids distinguishing between primary and secondary purposes.”
As stated in the chart above, a product does not meet the device definition if it “achieve[s] its primary intended purposes through chemical action within or on the body.” In classifying DSW as a drug in this case, FDA defined “achieve” in an interesting way: “Although the solution may also work through some degree of physical displacement, the evidence indicates that its chemical action meaningfully contributes to its primary intended purpose” (emphasis added). The court was quick to note that “achieve” does not mean “meaningfully contribute.”
[A]chieve” means “to carry out successfully;” to “accomplish;” “to attain a desired end or aim;” or “to get or attain as the result of exertion.” … “Contribute” connotes a lesser involvement: it means only “to help to cause something to happen;” “to give or supply in common with others;” or “to play a significant part in bringing about an end or result.
In ruling against FDA, the court stated: “Chemical action that helps or plays a significant part in bringing about a specific result is more than de minimis involvement, but it does not fulfill the congressional directive that the chemical action must achieve, i.e., accomplish or attain, the primary purpose.”
Additionally, the court found that FDA’s “meaningfully contribute” language appeared to be a “significant shift” in the agency’s practices when classifying products. The opinion noted that FDA provided no explanation for choosing this new interpretation of what it means when a product “achieves” its primary purpose.
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It will be interesting to see the effect of this case on FDA’s classifications going forward. While Prevor asked the court to make a “device” classification , the court here was unwilling to do so. The court noted the possibility on remand that FDA could (for the third time) find that DSW should be classified as a drug-device combination product with a drug mode of action if it “adopts a plausible construction of the relevant statutory language.” However, the court stated that they could not affirm FDA’s classification decision here because it was “based on an erroneous and unreasonable interpretation of the law.”
Judge Rosemary Collyer’s opinion could result in the FDA approaching their drug or device classification a bit more cautiously. Twice now the court has struck down FDA’s over-expansive interpretation of the Food, Drug, and Cosmetic Act. We will follow this case as it continues to work its way through the courts, as well as other FDA-related litigation.