No. 24-118

Pharmaceutical Research and Manufacturers of America v. Alan McClain, in His Official Capacity as Commissioner of the Arkansas Insurance Department, et al.

Lower Court: Eighth Circuit
Docketed: 2024-08-02
Status: Denied
Type: Paid
Amici (1) Experienced Counsel
Tags: 340b-drug-pricing-program administrative-enforcement administrative-law contract-pharmacies contract-pharmacy drug-pricing federal-preemption federal-regulation healthcare-policy state-preemption state-regulation statutory-interpretation
Key Terms:
SocialSecurity Jurisdiction JusticiabilityDoctri
Latest Conference: 2024-12-06
Question Presented (AI Summary)

Whether the Eighth Circuit erred in holding—in conflict with the decisions of other circuits and this Court—that a State may strip manufacturers of the ability preserved to them by 340B to impose conditions on the use of contract pharmacies as part of the offer to provide 340B-priced drugs and intrude on 340B's centralized enforcement scheme

Question Presented (from Petition)

QUESTION PRESENTED This Nation’s second largest drug program, the federal 340B Drug Pricing Program (840B), is administered by the U.S. Department of Health and Human Services (HHS) and effectuated through a contract between the federal government and drug manufacturers. It requires manufacturers to offer heavily discounted prescription drugs to certain statutorily enumerated healthcare entities called “covered entities.” The D.C. and Third Circuits have held that HHS cannot require drug manufacturers to deliver 340B-priced drugs to an unlimited number of third-party “contract pharmacies,” because Congress “preserved” manufacturers’ ability to impose conditions on the delivery of 340B-priced drugs as part of their offers, including as to the use of contract pharmacies. And this Court has previously held that the federal government alone possesses exclusive administrative and enforcement authority over 340B. Nevertheless, Arkansas and a growing number of other States have enacted laws forbidding manufacturers from imposing contract-pharmacy even HHS cannot do. In the decision below, the Eighth Circuit blessed Arkansas’s law, permitting the State to impose its own preferred obligations and enforcement scheme on 340B. The question presented is: Whether the Eighth Circuit erred in holding—in conflict with the decisions of other circuits and this Court—that a State may strip manufacturers of the ability preserved to them by 340B to impose conditions on the use of contract pharmacies as part of the offer to provide 340B-priced drugs and intrude on 340B’s centralized enforcement scheme.

Docket Entries

2024-12-09
Petition DENIED.
2024-11-19
DISTRIBUTED for Conference of 12/6/2024.
2024-11-19
Reply of petitioner Pharmaceutical Research and Manufacturers of America filed. (Distributed)
2024-11-04
Brief of Community Health Centers of Arkansas and Piggott Community Hospital in opposition submitted.
2024-11-04
Brief of Alan McClain, Commissioner of the Arkansas Insurance Department, et al. in opposition submitted.
2024-11-04
Brief of respondents Community Health Centers of Arkansas and Piggott Community Hospital in opposition filed.
2024-11-04
Brief of respondents Alan McClain, Commissioner of the Arkansas Insurance Department, et al. in opposition filed.
2024-11-04
Brief of respondent Alan McClain, Commissioner of the Arkansas Insurance Department, in opposition filed.
2024-09-03
Amicus brief of Kalderos, Inc. submitted.
2024-09-03
2024-08-21
Motion to extend the time to file a response is granted and the time is extended to and including November 4, 2024.
2024-08-20
Motion of Alan McClain, Commissioner of the Arkansas Insurance Department, et al. for an extension of time submitted.
2024-08-20
Motion to extend the time to file a response from September 3, 2024 to November 4, 2024, submitted to The Clerk.
2024-07-31
Petition for a writ of certiorari filed. (Response due September 3, 2024)

Attorneys

Alan McClain, Commissioner of the Arkansas Insurance Department, et al.
Nicholas Jacob BronniSolicitor General of Arkansas, Respondent
Nicholas Jacob BronniSolicitor General of Arkansas, Respondent
Community Health Centers of Arkansas and Piggott Community Hospital
Ronald Shreve ConnellyPowers, Pyles, Sutter and Verville, P.C., Respondent
Ronald Shreve ConnellyPowers, Pyles, Sutter and Verville, P.C., Respondent
Kalderos, Inc.
Paul J. ZidlickySidley Austin LLP, Amicus
Paul J. ZidlickySidley Austin LLP, Amicus
Pharmaceutical Research and Manufacturers of America
Gregory George GarreLatham & Watkins LLP, Petitioner
Gregory George GarreLatham & Watkins LLP, Petitioner