Astrazeneca Pharmaceuticals Lp v. Burwell
197 F. Supp. 3d 53
| D.D.C. | 2016Background
- AstraZeneca sued FDA under the APA seeking a TRO to block imminent final approvals of several ANDAs for generic Crestor, arguing FDA’s interpretation of pediatric-labeling carve-outs was unlawful and would cost AstraZeneca six months of market exclusivity.
- FDA and six generic manufacturers (intervenors) oppose the TRO, contending FDA has not made a final decision and the case is unripe; FDA defends its ongoing review and statutory constraints on delaying approvals.
- AstraZeneca also filed a pending citizen petition raising the same issues; 21 U.S.C. § 355(q)(2)(B) requires dismissal without prejudice when an overlapping citizen petition is pending unless exhausted administratively.
- The D.C. Circuit’s Teva precedent recognizes courts sometimes adjudicate exclusivity claims pre-ANDA approval but requires ripeness (fitness and finality) for pre-enforcement review.
- The court invoked the All Writs Act to preserve meaningful judicial review and crafted interim procedures balancing AstraZeneca’s need for a hearing, intervenors’ right to market, and minimal disruption to FDA processes.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Ripeness / Jurisdiction to review before FDA finalizes ANDAs | AstraZeneca: FDA likely decided to approve; courts should hear claim pre-approval to avoid irreparable loss of exclusivity | FDA: No final agency action yet; administrative review ongoing; case is unripe and dismissal may be required because citizen petition pending | Court agreed ripeness is doubtful for full merits but recognized need to preserve review; used All Writs Act to protect status quo pending final action |
| Use of All Writs Act to preserve status quo | AstraZeneca: Court may issue orders to preserve meaningful review and prevent market flooding post-approval | FDA: Reluctant to delay approvals but acknowledges courts may use limited procedures to enable prompt review | Court authorized limited equitable measures under All Writs Act to protect potential future jurisdiction and preserve status quo |
| Advance notice and hearing procedure for FDA decisions | AstraZeneca: Requested 48 hours’ notice before FDA decision so counsel and court can convene | FDA/Intervenors: Opposed 48-hour notice; propose shorter notice to Court only or in-court issuance to avoid market effect | Court ordered FDA to give the Court (only) 24 hours’ notice; scheduled a closed, sealed hearing at which FDA must issue its citizen-petition decision and any ANDA decisions; counsel must be ready on two hours’ notice |
| Access to draft labeling and administrative record | AstraZeneca: Needs intervenors’ draft labels and prompt administrative record to prepare TRO briefing | FDA/Intervenors: Draft labels are not discoverable; assembly/redaction of record takes time; final labeling will be in record | Court declined to compel production of draft labels; will require FDA to bring copies of final labeling, decisions, and key materials (15 copies) to the sealed hearing and will address full record timing at the hearing |
Key Cases Cited
- Teva Pharm. USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010) (pre-enforcement review of exclusivity issues may be appropriate when dispute is fit and agency action is final)
- FTC v. Dean Foods Co., 384 U.S. 597 (U.S. 1966) (All Writs Act permits courts to preserve jurisdiction and status quo pending agency review)
- Arrow Transportation Co. v. Southern R.R. Co., 372 U.S. 658 (U.S. 1963) (All Writs Act recognized as source of ancillary injunctive powers)
- Wagner v. Taylor, 836 F.2d 566 (D.C. Cir. 1987) (incidental equitable jurisdiction allows temporary restraints to preserve claim ripeness)
- Nat’l Treasury Employees Union v. King, 961 F.2d 240 (D.C. Cir. 1992) (courts may use equitable powers to protect potential future jurisdiction)