AstraZeneca Pharmaceuticals LP v. Food & Drug Administration
404 U.S. App. D.C. 339
| D.C. Cir. | 2013Background
- AstraZeneca appeals a district court grant of summary judgment in favor of the FDA denying exclusivity for Table 2 under the sNDA/pediatric indications framework.
- FDCA provides three-year exclusivity for supplements containing reports of new clinical investigations essential to the supplement's approval; adjustments can extend to three years and six months with pediatric data when requested by FDA.
- Table 2 data were submitted in general correspondence letters and were not contained in a separate pediatric or other supplement; FDA treated Table 2 labeling as separate from pediatric supplements.
- FDA approved the pediatric sNDAs and labeling changes (including Table 2) on December 2, 2009; AstraZeneca sought exclusivity for Table 2 in September 2011, which the FDA denied.
- In March 2012, the FDA approved ANDAs incorporating Table 2; AstraZeneca challenged this as contrary to the exclusivity statute, leading to the appeal.
- The court analyzes mootness but ultimately proceeds under Chevron deference to FDA's interpretation of the exclusivity provisions.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Table 2 is entitled to exclusivity under 21 U.S.C. § 355(j)(5)(F)(iv). | AstraZeneca argues Table 2 was a change approved in the pediatric supplements and relied on new investigations essential to that approval. | FDA contends Table 2 was not a change approved in a supplement and was not derived from essential data in a supplement. | No exclusivity for Table 2; FDA reasonably interpreted the statute. |
| Whether the FDA reasonably construed 'supplement' and related terms to exclude Table 2 from exclusivity. | AstraZeneca asserts the statute's language clearly entitles exclusivity for changes supported by new investigations in the supplements. | FDA maintains Table 2 was separate from pediatric supplements and not a change approved in a supplement. | FDA's construction is reasonable under Chevron; not an arbitrary or capricious interpretation. |
| Whether the case is moot given potential six-month pediatric exclusivity and ongoing rights. | If exclusivity for Table 2 existed, AstraZeneca would gain up to June 2013. | Posture argues mootness since exclusivity could have expired, with some ambiguity about pediatric extension. | Not moot; potential pediatric exclusivity could extend rights, so decision affects ongoing rights. |
| Whether the FDA’s interpretation should be reviewed under Chevron deference in an APA context. | AstraZeneca contends the statute is clear and requires exclusivity for Table 2. | FDA argues the statute is ambiguous and leaves room for reasonable agency interpretation. | Under Chevron, agency's reasonable interpretation controls; court affirms. |
Key Cases Cited
- AstraZeneca Pharm. LP v. FDA, 872 F. Supp. 2d 60 (D.D.C. 2012) (district court ruling on exclusivity and Table 2; precedential to agency interpretation)
- FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (S. Ct. 2000) (implicit delegation to agency to fill statutory gaps)
- Chevron U.S.A. Inc. v. NRDC, 467 U.S. 837 (S. Ct. 1984) (establishes step-one/step-two approach for agency deference)
- Honig v. Doe, 484 U.S. 305 (S. Ct. 1988) (justice and mootness considerations in Article III disputes)
- LaRoque v. Holder, 679 F.3d 905 (D.C. Cir. 2012) (live controversy requirement and mootness relevance)
- Clarke v. United States, 915 F.2d 699 (D.C. Cir. 1990) (en banc consideration in administrative law context)
- Sherley v. Sebelius, 689 F.3d 776 (D.C. Cir. 2012) (APA summary judgment standard for arbitrary and capricious agency action)
- Calhoun v. Johnson, 632 F.3d 1259 (D.C. Cir. 2011) (de novo review of agency actions in summary judgment posture)