Author: Tom Mirga

Origin Biosciences Posts Limited Distribution Notice on 340B Program Site

In Federal, Pharma Industry, RegulatoryMarch 30, 20210 Views

The manufacturer of Nulibry, a recently approved, first-of-its-kind injectable treatment for a very rare, often fatal genetic disorder that typically appears soon after birth, has posted details about the limited distribution network for the drug on the U.S. Health Resources …

HRSA Takes Step Forward on 340B Dispute Resolution Petitions

In Federal, Judicial, RegulatoryMarch 25, 20216 Views

Tom Mirga

The federal government on Tuesday declared 340B administrative dispute resolution (ADR) petitions by covered entities against drug manufacturers AstraZeneca, Eli Lilly, and Sanofi to be “complete,” a sign that claims against two of the three companies—AstraZeneca and Sanofi—are ready for …

Merck Pitches Its Voluntary 340B Integrity Initiative to Providers as a Better Option than Audits

In Pharma IndustryMarch 25, 20212 Views

Tom Mirga

Drug manufacturer Merck sent letters to 340B covered entities by email on Tuesday to provide background and answer questions about its request that entities voluntarily upload their contract pharmacy claims to a vendor’s software platform so they can be checked …

Feds Oppose Hospitals’ Motion to Intervene in Novo Nordisk’s 340B Lawsuit

In Federal, JudicialMarch 25, 20213 Views

Tom Mirga

The federal government on Monday strongly objected to letting six hospital groups participate as third parties in drug manufacturer Novo Nordisk’s lawsuit challenging the government’s 340B contract pharmacy requirements.

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340B Dispute Resolution Injunction Is Having Ripple Effects

In Federal, JudicialMarch 23, 20211 Views

Tom Mirga

The federal judge considering drug manufacturer Sanofi’s motion for protection from 340B dispute resolution proceedings asked the company and the federal government last Wednesday to brief her on a different federal judge’s order the day before granting drug company Eli …

Federal Judge To Get Status Report Today from Ryan White Clinics and Government

In Federal, JudicialMarch 23, 20211 Views

Tom Mirga

Ryan White Clinics for 340B Access (RWC-340B) and the federal government have a deadline today to report to a federal judge about whether to continue the stay in the group’s suit to force the government to act against drug manufacturers …

Drug Pricing Is Heating Up in Congress Again

In Federal, LegislativeMarch 23, 20212 Views

Tom Mirga

A few years ago, there was hope that congressional Democrats and Republicans and the Trump administration would unite and enact legislation addressing the high price of prescription drugs. It never happened. Today, the new session of Congress is taking its …

Health Centers Get Reprieve as 340B Insulin Pricing Rule Delayed Again

In Federal, RegulatoryMarch 19, 20211 Views

Tom Mirga

The U.S. Health and Human Services Department (HHS) announced late this morning that it will delay, from this coming Monday, March 22 until July 20, the effective date of a Trump administration rule to require health centers to provide insulin …

Six Senators Reintroduce Bipartisan Bill to Protect 340B Hospitals From COVID Fallout

In Federal, LegislativeMarch 18, 20213 Views

Tom Mirga

A bipartisan group of six U.S. senators on Tuesday reintroduced legislation from the last session of Congress to protect hospitals from losing eligibility for 340B drug discounts during the COVID-19 pandemic.

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Sanders Holding Senate Hearing on Drug Prices Next Week

In Federal, LegislativeMarch 18, 20214 Views

Tom Mirga

U.S. Sen. Bernie Sanders (I-Vt.) has scheduled a hearing next Tuesday of the U.S. Senate health subcommittee he chairs on why the United States pays the highest prices in the world for prescription drugs.

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