Astrazeneca Pharmaceuticals Lp v. Food and Drug Administration
2012 U.S. Dist. LEXIS 92663
| D.D.C. | 2012Background
- AstraZeneca sues the FDA challenging the FDA’s March 27, 2012 approval of generic quetiapine (Seroquel) ANDAs.
- AstraZeneca seeks three-year exclusivity over Table 2 safety labeling data under 21 U.S.C. § 355(j)(5)(F)(iv).
- FDA denied exclusivity for Table 2, arguing the data is generally applicable safety information and not essential to a supplement’s approval.
- AstraZeneca had obtained pediatric indications (sNDAs) for Seroquel on December 2, 2009, each supported by separate clinical investigations.
- The FDA concluded Table 2 was not tied to the pediatric changes and was not entitled to exclusivity; the agency issued a comprehensive 17-page rationale.
- The court granted summary judgment for the FDA and denied AstraZeneca’s request.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether § 355(j)(5)(F)(iv) grants exclusivity for Table 2 | AstraZeneca asserts Table 2 arose from new clinical investigations essential to its supplement. | FDA contends statute requires nexus between new investigations and the supplement; not all labeling changes are eligible. | Ambiguous; FDA reasonable interpretation controls. |
| Whether pediatric indications support exclusivity for Table 2 | Pediatric sNDAs and related data create a nexus to Table 2 exclusivity. | No nexus; pediatric approvals were independent of Table 2. | No exclusivity for Table 2. |
| Whether Table 2 data constitutes a supplement or new clinical investigation | Table 2 data derived from new investigations should be treated as a supplement. | Data submit in correspondence; not a formal supplement; not a new clinical investigation for exclusivity. | Table 2 data not a valid supplement or exclusive basis. |
| Whether FDA’s interpretation is arbitrary or capricious | FDA misapplied exclusivity to a broad safety data change. | Interpretation consistent with practice and statutory balance. | FDA’s interpretation not arbitrary or capricious. |
| ChevronStep Two: whether FDA’s interpretation is reasonable | Statutory terms unambiguous; exclusivity should extend to Table 2. | Ambiguity exists; deference to agency warranted. | FDA’s interpretation reasonable; upheld. |
Key Cases Cited
- Allergan, Inc. v. Crawford, 398 F. Supp. 2d 13 (D.D.C. 2005) (exclusivity tied to data essential to approval of a clinical efficacy supplement)