Category: Federal

Senate Finance Report Might Shed Light on Insulin Manufacturers’ 340B Contract Pharmacy Actions

In Federal, Legislative, Pharma IndustryJanuary 19, 2021

U.S. insulin manufacturer and pharmacy benefit manager (PBM) business practices “have created a vicious cycle of price increases that have sent costs for patients and taxpayers through the roof,” U.S. Senate Finance Committee leaders Chuck Grassley (R-Iowa) and Ron Wyden …

Azar and Verma Touch on 340B in Valedictory Remarks

In Federal, RegulatoryJanuary 19, 2021

Tom Mirga

Outgoing U.S. Health and Human Services (HHS) Secretary Alex Azar and Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma both referred to 340B—obliquely in Azar’s case, directly in Verma’s—in recent farewell remarks.

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340B Stakeholders Reconsider Campaign Contributions in Wake of Capitol Riot

In Federal, Pharma Industry, Trade AssociationJanuary 19, 2021

Tom Mirga

National health care organizations and businesses with major stakes in the 340B program have suspended political contributions following a pro-Trump mob’s Jan. 6 violent attack on Congress to stop it from counting and certifying the Electoral College’s votes for president. …

Health Centers File 340B Dispute Resolution Petitions Against Drug Manufacturers

In Federal, Judicial, Pharma Industry, RegulatoryJanuary 14, 2021

Tom Mirga

The National Association of Community Health Centers (NACHC) last night on its members’ behalf asked a new federal 340B program administrative dispute resolution (ADR) panel to order drug manufacturers Eli Lilly and Co., Sanofi, and AstraZeneca to lift all “qualifications, …

Lilly Asks Court to Shield it From “Crippling” 340B Sanctions

In Federal, Judicial, Pharma IndustryJanuary 14, 2021

Tom Mirga

340B program stakeholders are still digesting drug manufacturers AstraZeneca, Eli Lilly and Co., and Sanofi’s Jan. 12 lawsuits to block federal sanctions over their decisions to stop or impose conditions on 340B discounts on drugs dispensed by contract pharmacies. …

AstraZeneca, Lilly, and Sanofi Sue HHS to Block Requirement To Give 340B Discounts To Contract Pharmacies

In Federal, Judicial, Pharma Industry, RegulatoryJanuary 13, 2021

Tom Mirga

In a major escalation of the fight over 340B contract pharmacy, drug manufacturer AstraZeneca late yesterday asked a federal court to declare that it “is not required to offer 340B discounts to contract pharmacies.”

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HRSA Releases Details and FAQs About New 340B Dispute Resolution System

In Federal, RegulatoryJanuary 12, 2021

Tom Mirga

The U.S. Health Resources and Services Administration (HRSA) Tuesday afternoon posted a new webpage describing the steps health care providers and drug manufacturers must follow to invoke the 340B program’s new administrative dispute resolution (ADR) process. It simultaneously posted 11 …

340B Providers Blindsided by Bausch Health’s Decision to Drop AmerisourceBergen as Distributor

In Federal, Other Industry, Pharma Industry, RegulatoryJanuary 12, 2021

Tom Mirga

Drug manufacturer Bausch Health blindsided 340B covered entities on New Year’s Eve, announcing that starting the very next day, Jan. 1, more than 200 of its branded products and future branded products would no longer be available through distributor AmerisourceBergen …

Senate Democratic Chairs-in-Waiting Waste No Time Going to Bat for 340B Providers

In Federal, Legislative, Pharma Industry, RegulatoryJanuary 12, 2021

Tom Mirga

The incoming Democratic chairs of two key U.S. Senate committees want the federal agency in charge of the 340B program “to take immediate action to clarify that implementation of a rebate model by [drug] manufacturers would violate a material condition …

BREAKING: HHS’s Top Lawyer Says Pharma’s 340B Contract Pharmacy Actions Are at Odds with the Law

In Breaking, Federal, Judicial, RegulatoryDecember 31, 2020

Tom Mirga

The U.S. Health and Human Services Department’s (HHS) top lawyer today rejected drug manufacturers’ legal arguments for either ending or imposing conditions on 340B pricing on covered outpatient drugs shipped to contract pharmacies.

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