J&J Pauses Rebate Model After HRSA Warning
Yesterday, Johnson & Johnson Health Care System Inc. (J&J) stated in a letter to HRSA that it will halt implementation of its proposed rebate model, which was set to take…
Two Covered Entity Hospitals Sue HRSA Over Johnson & Johnson Request for Audit
On July 24, 2024, two hospital-covered entities sued the Health Resources and Services Administration (“HRSA”), arguing that HRSA’s approval of J&J’s 340B audit request against them was unlawful and premature. The…
HHS Issues Revised ADR Regulations
Today, HHS published revised 340B administrative dispute resolution regulations (ADR Rule) that will replace existing ADR regulations effective June 18. Most notably, the ADR Rule does not include a proposal…
RWC-340B Sends Letters to Gilead, HHS Secretary, and OPA Director.
A growing number of pharmaceutical manufacturers have recently posed restrictions affecting Ryan White Clinics and other Safety Net Providers. RWC-340B has taken action to address these challenges head-on. On…
New AbbVie and Lilly Contract Pharmacy Policies
AbbVie is the 11th Manufacturer to Restrict Access to 340B Prices at Contract Pharmacies By letter dated December 29, 2021, AbbVie announced that, effective February 1, 2022, it will implement…
UCB Latest Manufacturer to Announce Restrictive Contract Pharmacy Policy; HRSA Issues Statement Regarding Manufacturer Lawsuits
By letter dated November 22, 2021, drug manufacturer UCB, Inc. notified covered entities that it is “altering its 340B policy” and will no longer honor contract pharmacy arrangements, effective December…
Update on 340B Contract Pharmacy Litigation — Decisions Issued in Four Manufacturer Lawsuits
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…
RWC-340B Applauds Court’s “Fairest and Most Reasonable” Interpretation of the 340B Drug Pricing Program: Manufacturer Actions Shall Not Undermine the Safety Net
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…
Indiana Federal Court Issues Decision in Eli Lilly’s Contract Pharmacy Lawsuit
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…
Boehringer Ingelheim Is Latest Manufacturer to File a Lawsuit Against HHS On Contract Pharmacy Program
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…