67 F. Supp. 3d 125
D.D.C.2014Background
- Prevor developed Diphoterine™ Skin Wash (DSW), an aerosol canister whose liquid both mechanically washes chemicals off skin and chemically neutralizes/draws chemicals out of skin; Prevor estimated ~90% mechanical, ~10% chemical effect.
- FDA’s Office of Combination Products initially designated DSW a combination product, classifying the liquid as a drug because it "achieves its primary intended purposes, at least in part, through chemical action."
- This Court (PREVOR I) remanded, criticizing FDA’s expansive reading that a de minimis chemical effect suffices and directing FDA to clarify what constitutes a "primary intended purpose."
- On remand FDA changed tack: it treated DSW’s single primary purpose as "to help prevent and minimize accidental chemical burn injuries" and adopted a new standard that chemical action need only "meaningfully contribute" (not fully "achieve") that purpose to trigger drug regulation.
- The Court found FDA’s single-purpose framing reasonable given Prevor’s own statements, but held FDA’s substitution of "meaningfully contributes" for the statutory term "achieve" was legally erroneous and arbitrary; vacated FDA’s designation and remanded for further proceedings.
Issues
| Issue | Prevor's Argument | FDA's Argument | Held |
|---|---|---|---|
| Proper statutory standard under 21 U.S.C. § 321(h): whether a chemical action must "achieve" a product's primary intended purpose to exclude device classification | "Achieve" requires the chemical action to accomplish the primary purpose; de minimis or merely contributory chemical effects insufficient | Statute ambiguous about degree; agency may treat a product as a drug if chemical action "meaningfully contributes" to the primary purpose | Court held statute unambiguous: "achieve" is not synonymous with "meaningfully contributes"; FDA's substitution was unlawful and arbitrary |
| Identification of primary intended purpose (single vs multiple purposes) | DSW’s stated purpose is to prevent/minimize chemical burns; mechanical vs chemical modes are modes of action, not separate primary purposes | FDA initially identified two primary purposes, then on remand adopted Prevor’s broader single-purpose framing to avoid primacy analysis | Court found FDA’s adoption of Prevor’s single primary purpose reasonable on the record |
| Sufficiency of FDA’s scientific assessment that chemical action is primary | Prevor: studies show predominant mechanical effect; chemical action is secondary | FDA: literature and studies (including Prevor’s materials) show chemical properties materially (and in FDA’s view substantially) contribute to efficacy | Court deferred to agency expertise on scientific evidence but could not uphold classification because legal standard applied was erroneous; factual findings may be reconsidered on remand |
| Appropriate remedy (judicial classification vs remand) | Prevor sought a declaration that DSW is a device and judgment for Prevor | FDA urged deference and remand | Court vacated FDA’s designation as arbitrary and capricious but declined to classify DSW itself; remanded to FDA for reconsideration under correct legal standard |
Key Cases Cited
- Chevron U.S.A., Inc. v. Natural Resources Defense Council, 467 U.S. 837 (agency deference framework)
- Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (arbitrary and capricious standard)
- Goldstein v. Securities & Exchange Commission, 451 F.3d 873 (agency interpretation must conform to statutory meaning)
- Serono Labs., Inc. v. Shalala, 158 F.3d 1313 (deference to reasonable agency interpretation)
- A.L. Pharma, Inc. v. Shalala, 62 F.3d 1484 (remand appropriate where agency action arbitrary or inadequately explained)
- Rempfer v. Sharfstein, 583 F.3d 860 (deference to agency scientific determinations)