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United States District Court for the District of Delaware
February 16, 2022, Decided; February 16, 2022, Filed
C.A. No. 21-27-LPS
/s/ Leonard P. Stark
STARK, U.S. District Judge:
On May 17, 2021, the Acting Administrator of the Health Resources and Services Administration ("HRSA") within the U.S. Department of Health and Human Services ("HHS") sent a letter to AstraZeneca Pharmaceuticals LP ("AstraZeneca" or "AZ"). In the letter, HRSA notified AstraZeneca of HRSA's conclusion that AstraZeneca has violated its obligations under the federal 340B Program. In this Court, AstraZeneca challenges this "Violation Letter," arguing that the agency did not comply with the Administrative Procedure Act ("APA"), 5 U.S.C. §§ 701-06. AstraZeneca and the government have both moved for summary judgment on the administrative record.
As the Court previously acknowledged (see D.I. 78 at 1), this case implicates a number of important issues of [*2] public policy, including funding for healthcare facilities across the country and access to care — especially for low-income individuals — at those facilities. As before, the Court must set aside any personal views it may have on these matters and decide only the narrow question properly before it, which is now: did HRSA comply with the APA when it issued the Violation Letter? For the reasons explained below, the Court concludes that HRSA did not.
Accordingly, the Court will vacate and set aside the Violation Letter and remand to the agency for further consideration in light of the Court's opinion. The Court will also solicit the parties' views on the impact of the Court's conclusions on the claims for relief in AstraZeneca's second amended complaint and whether (and, if so, how) this case should now proceed.
Full case includes Shepard's, Headnotes, Legal Analytics from Lex Machina, and more.
2022 U.S. Dist. LEXIS 27842 *; 2022 WL 484587
ASTRAZENECA PHARMACEUTICALS LP, Plaintiff, v. XAVIER BECERRA, DANIEL J. BARRY, DIANA ESPINOSA, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, and HEALTH RESOURCES AND SERVICES ADMINISTRATION, Defendants.
Prior History: Astrazeneca Pharms. LP v. Becerra, 543 F. Supp. 3d 47, 2021 U.S. Dist. LEXIS 113254, 2021 WL 2458063 (D. Del., June 16, 2021)
pharmacies, covered entity, drugs, manufacturers, drug manufacturer, outpatient, dispensing, documents, vacate, memorandum opinion, ceiling price, sales, obligations, entities', unlimited, administrative record, summary judgment, purchases, briefing, parties, guidelines