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 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),…
Late Tuesday evening, the U.S. House of Representatives approved an amendment to the House Appropriations Labor, Health and Human Services legislation that supports agency action against manufacturers that are not…
On July 19, HHS and the Departments of Labor and Treasury took an important step to remove insurance copayment requirements as a barrier to access to HIV preexposure prophylaxis (“PrEP”)…