GRACEWAY PHARMACEUTICALS, INC. v. Sebelius
783 F. Supp. 2d 104
D.D.C.2011Background
- Graceway manufactures Aldara (imiquimod) topical cream with three FDA-approved indications: genital warts (EGW), actinic keratoses, and superficial basal cell carcinoma (sBCC).
- Nycomed sought FDA approval for a generic imiquimod cream and proposed a single bioequivalence study using actinic keratoses patients; FDA initially favored this approach for several applicants.
- FDA ultimately issued a Citizen Petition Response (Jan. 26, 2010) sustaining that actinic keratoses alone could demonstrate bioequivalence across all three indications.
- Dermatology Division recommended testing on EGW due to site-of-action differences, but the FDA Director Beitz overruled and concluded actinic keratoses sufficed.
- Graceway challenged the FDA’s Response as arbitrary, capricious, or contrary to law under the APA, arguing the FDA mischaracterized site of action and relatedness among indications.
- Court grants Defendants’ summary judgment, denies Graceway’s, holding FDA’s explanations were reasoned and supported by scientific literature.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether FDA’s site-of-action conclusion was rational | Graceway argues sites differ and EGW cannot be extrapolated | FDA found no significant absorptive differences and proper rational basis | Granted to Defendants |
| Whether FDA adequately explained relatedness of indications | Graceway asserts Dermatology Division’s views undermine final decision | FDA provided thorough, reasoned analysis linking indications by response to imiquimod | Granted to Defendants |
Key Cases Cited
- Serono Labs., Inc. v. Shalala, 158 F.3d 1313 (D.C.Cir. 1998) (deference to FDA scientific expertise in data evaluations)
- Astellas Pharma US, Inc. v. FDA, 642 F.Supp.2d 10 (D.D.C. 2009) (deference to FDA methodologies for bioequivalence)
- Bristol-Myers Squibb Co. v. Shalala, 923 F.Supp. 212 (D.D.C. 1996) (requires rational explanation for agency action)
- Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (U.S. 1983) (arbitrary or capricious review standard; reasoned decision required)
- Pub. Citizen, Inc. v. FAA, 988 F.2d 186 (D.C.Cir. 1993) (agency must explain why it chose its course of action)
- Tourus Records, Inc. v. DEA, 259 F.3d 731 (D.C.Cir. 2001) (brief explanation acceptable if it shows the agency’s path)