On Friday, November 5, two federal courts issued decisions in four of the lawsuits that drug manufacturers filed against HHS challenging HHS’ May 17 cease-and-desist letters (“May 17 Letters”) notifying…
PRESS STATEMENT: FOR IMMEDIATE RELEASE Contact: Peggy.Tighe@PowersLaw.com RWC-340B Applauds Court’s “Fairest and Most Reasonable” Interpretation of the 340B Drug Pricing Program: Manufacturer Actions Shall Not Undermine the Safety Net…
On Friday, the U.S. District Court for the Southern District of Indiana (the Court) issued a decision supporting HRSA’s statutory interpretation, as reflected in HRSA’s May 17 determination, that Eli…
On October 25, 2021, drug manufacturer Boehringer Ingelheim Pharmaceuticals, Inc. filed a lawsuit in the U.S. District Court for the District of Columbia against HHS, alleging that HHS’s policy on…
On September 30, U.S. Representative Matt Rosendale (R-MT) introduced the Drug Pricing Transparency and Accountability Act (H.R. 5463), which would amend the 340B statute to add a two-year moratorium on…
On October 7, technology company Kalderos Inc. filed a lawsuit in the U.S. District Court for the District of Columbia against HHS alleging that HRSA’s contract pharmacy policy is unlawful. …
The law firm representing United Therapeutics (UT), Latham & Watkins, has filed a request with HRSA to obtain a wide range of records related to HRSA’s enforcement of the 340B…
On September 23, U.S. Senator Mike Braun (R-IN) introduced a bill to amend the 340B statute to allow HHS to audit 340B covered entities to determine how they use “net…
Earlier today, HRSA sent letters to Eli Lilly, AstraZeneca, Novartis, Novo Nordisk, Sanofi, and United Therapeutics alerting them that the agency has notified the HHS-Office of the Inspector General (OIG),…
On July 11, the U.S. House Appropriations Committee approved the fiscal year (FY) 2022 appropriations bill (the “Bill”) and accompanying report for the Department of Labor, HHS, Education, and Related…