Americans for Safe Access v. Drug Enforcement Administration
403 U.S. App. D.C. 388
| D.C. Cir. | 2013Background
- DEA lists marijuana as Schedule I under the CSA, restricting production, sale, and use; Petitioners (ASA, CRC, POT, and individuals) seek to reschedule it to Schedule III–V.
- Petition to reschedule was filed in Oct. 2002; the DEA denied on July 8, 2011, citing no currently accepted medical use and inadequate evidence.
- Petitioners challenge the denial as arbitrary and capricious; Government argues lack of Article III standing and merits dismissal.
- Court held at least one petitioner (Krawitz) has standing to challenge the DEA action; standing determination drives review proceeding.
- On the merits, the court applies a five-factor test for current accepted medical use; the DEA’s interpretation requiring adequate and well-controlled studies is upheld as supported by substantial evidence.
- Petitioners sought review under the APA; court concludes the DEA’s denial is not arbitrary or capricious under 5 U.S.C. § 706(2)(A).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Standing adequacy for review | Krawitz has standing as VA recipient harmed by Schedule I policy | Standing not established for petitioners as a group | Krawitz has standing; others need not be decided |
| DEA denial arbitrary and capricious | DEA ignored peer-reviewed studies showing efficacy | Agency’s five-factor test governs; no error in application | DEA denial upheld under arbitrary-and-capricious standard |
| Adequate and well-controlled studies | Peer-reviewed studies prove efficacy | Need NDA-quality, well-controlled trials; not met | DEA interpretation requiring NDA-like evidence permissible; record supports denial |
| Treatment of five-factor test | All five elements must be satisfied for current medical use | All five elements not satisfied; only one element at issue | Only the fifth element governs disposition; five-factor framework applied and upheld |
| Redressability and causation | Rescheduling will enable VA to complete state forms | Redressability speculative given federal-state dynamics | Redressability found with effect on VA policy via scheduling change |
Key Cases Cited
- Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994) (approval of DEA five-factor test for currently accepted medical use)
- Motor Vehicle Mfrs. Ass’n of the U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (U.S. 1983) (arbitrary-and-capacious review standard)
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (U.S. 1992) (standing requirements; injury, causation, redressability)
- Tozzi v. U.S. Department of Health and Human Services, 271 F.3d 301 (D.C. Cir. 2001) (causation/redressability in regulatory challenges)
- National Wrestling Coaches Ass’n v. U.S. Dep’t of Educ., 366 F.3d 930 (D.C. Cir. 2004) (standing when third-party actions are speculative)
- Renal Physicians Ass’n v. U.S. Department of Health & Human Services, 489 F.3d 1267 (D.C. Cir. 2007) (standing and redressability in regulatory challenges)
- Gettman v. DEA, 290 F.3d 430 (D.C. Cir. 2002) (standing in marijuana rescheduling challenge)