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HRSA Notifies Six Drug Manufacturers of Referral to OIG for Possible Penalties

by keith | Sep 22, 2021 | 340B, Litigation, News and Updates

The Health Resources and Services Administration (HRSA) has taken additional steps to require 340B drug discounts when drugs are dispensed through contract pharmacies. On September 22, HRSA followed up on earlier letters to six manufacturers refusing contract pharmacy...

HRSA Withdraws Contract Pharmacy Advisory Opinion But Will Continue Enforcement of Statute, Including Pursuant to May 17 Letters

by keith | Jun 18, 2021 | 340B, Litigation

The Health and Resource Service Administration (HRSA) announced June 18, in connection with the ongoing AstraZeneca case, that is withdrawing its December 2020 contract pharmacy Advisory Opinion “to avoid confusion and unnecessary litigation.” Despite withdrawal of...

Judge in AstraZeneca Lawsuit Denies Government’s Motion to Dismiss

by keith | Jun 16, 2021 | 340B, Litigation, News and Updates

A district court judge in Delaware issued an opinion denying the government’s motion to dismiss a lawsuit regarding a December 2020 Advisory Opinion issued by the Health and Resource Service Administration (HRSA). The judge concluded that the 340B statute is silent as...

Manufacturers Respond to HRSA 340B Cease and Desist Letter

by keith | Jun 10, 2021 | 340B, Litigation, News and Updates

On June 10, 2021, Eli Lilly became the third manufacturer to response to HRSA’s May 17th Cease and Desist letter on 340B drug pricing. The response details Eli Lilly’s rejection of HRSA’s reasoning in its Cease and Desist letter, arguing that the agency’s reasoning is...

HRSA Issues Cease and Desist Letters to Manufacturers Restricting Use of Contract Pharmacies

by keith | May 18, 2021 | 340B, Litigation, News and Updates

On May 17, 2021, the Health and Resource Service Administration (HRSA) issued letters to six pharmaceutical manufacturers requiring the entities to immediately cease an ongoing practice of withholding 340B pricing to covered entities utilizing contract pharmacies....

Judge Enjoins 340B ADR Rule, But Only as Applied to Eli Lilly

by keith | Mar 16, 2021 | 340B, Litigation, News and Updates

A district court judge in Indiana today issued a narrow ruling enjoining the Department of Health and Human Services (HHS) from implementing a rule issued in December finalizing administrative dispute resolution (ADR) procedures for the 340B program. Eli Lilly argued...
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