Author: Tom Mirga

House Appropriators Want an Update from HRSA on its Plans to Clarify 340B Patient Definition and Provider Eligibility Criteria, Calls for New GAO Report

In Federal, LegislativeJuly 15, 2021327 Views

House appropriators want GAO to update its pivotal 2011 report on 340B, and want HRSA to report on its plans to implement the report's remaining two recommendations, which focus on clarifying eligibility criteria for 340B patients and providers.

In addition to weighing in on the ongoing 340B contract pharmacy standoff (see related story), the U.S. House Appropriations Committee has entered the thicket of the highly controversial topics of 340B patient definition and provider eligibility.

In its report

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Law Firm Sues HRSA Over FOIA Request for 340B Contract Pharmacy Documents

In Federal, JudicialJuly 15, 2021197 Views

Tom Mirga

Law firm Latham & Watkins says HRSA is impeding its access to records it needs to represent United Therapeutics in its 340B contract pharmacy lawsuit against HRSA and HHS. | Shutterstock

The law firm representing United Therapeutics (UT) in its 340B contract pharmacy lawsuit against the federal government has filed its own related lawsuit against the government.

In a July 13 complaint filed in federal district court in Washington, D.C.,

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Feds, Novartis, and UT Weigh in on Consolidating 340B Contract Pharmacy Lawsuits

In Federal, JudicialJuly 15, 2021147 Views

Tom Mirga

U.S. District Judge Dabney Friedrich is expected to rule soon on whether to consolidate Novartis and United Therapeutics’ 340B contract pharmacy lawsuits.

The federal government told a federal district judge yesterday it consents to the judge’s proposal to speed up and simultaneously consider Novartis and United Therapeutics’ (UT) pending motions for preliminary injunctions in the two companies’ 340B contract pharmacy lawsuits. The …

Lilly Updates its Arguments in 340B Contract Pharmacy Lawsuit

In Federal, JudicialJuly 15, 2021178 Views

Tom Mirga

Drug maker Eli Lilly filed a brief in federal district court yesterday refreshing its arguments in its 340B contract pharmacy lawsuit.

Drug manufacturer Eli Lilly yesterday responded to the federal government’s June 25 motion to a federal judge in Indianapolis to dismiss the company’s case challenging the legality and constitutionality of the government’s 340B contract pharmacy requirements and 340B administrative dispute …

FQHCs Say Patients Will Suffer if Telehealth Flexibilities Aren’t Extended

In Research/ReportsJuly 15, 202183 Views

Tom Mirga

NACHC says millions of health center patients could lose access to care if Congress and the Biden administration fail to extend telehealth flexibilities granted during the COVID-19 pandemic.

Millions of community health center patients could lose access to care if Congress and the Biden administration fail to extend telehealth flexibilities granted during the COVID-19 pandemic, especially for audio-only telehealth, a new survey report warns.

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Sixth Drug Manufacturer Sues HHS and HRSA Over 340B Contract Pharmacy

In Federal, JudicialJuly 13, 2021514 Views

Tom Mirga

United Therapeutics sued HHS and HRSA on June 23 over 340B contract pharmacy requirements.

Drug manufacturer United Therapeutics (UT) has sued the federal government over its 340B contract pharmacy requirements, saying it is being forced “to engage in a program that enriches national pharmacy corporations at UT’s direct expense and at the expense of …

Multiple Developments in 340B Contract Pharmacy Lawsuits

In Federal, JudicialJuly 13, 2021802 Views

Tom Mirga

There have been multiple recent developments in drug manufacturers' lawsuits challenging the legality of 340B contract pharmacy requirements.

Drug maker Sanofi last week updated its lawsuit challenging federal 340B contract pharmacy requirements to poke holes in the government’s introduction of, in the government’s words, “over six thousand pages of complaints from covered entities” about Sanofi’s alleged overcharges for …

Biden Gives Becerra 45 Days to Deliver a Plan to Fight Excessive Drug Prices

In Federal, RegulatoryJuly 13, 2021145 Views

Tom Mirga

President Biden has given HHS Secretary Xavier Becerra an Aug. 23 deadline for a plan “to combat excessive pricing of prescription drugs.”

President Biden last Friday gave U.S. Health and Human Services Secretary Xavier Becerra 45 days to deliver a plan “to combat excessive pricing of prescription drugs.” Becerra’s deadline is Aug. 23.

Biden included drug pricing directives in a far-ranging July

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Boehringer Ingelheim Will Stop Shipping 340B Drugs to Hospitals’ Contract Pharmacies on Aug. 1

In Breaking, Pharma IndustryJuly 1, 20212674 Views

Tom Mirga

Hospitals call Boehringer Ingelheim’s contract pharmacy plans “appalling” while company calls for “substantial reform” of the 340B program.

Drug manufacturer Boehringer Ingelheim (BI) announced yesterday that it will stop shipping 340B-purchased drugs to hospitals’ contract pharmacies, effective Aug. 1.

Community health centers, HIV/AIDS clinics, and other federal grantee covered entities are exempt from BI’s new policy. It applies

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Judge Rejects Government’s Contention that AstraZeneca’s 340B Lawsuit Is Moot

In Breaking, Federal, JudicialJuly 1, 2021684 Views

Tom Mirga

A federal judge yesterday, acting in a lawsuit filed by AstraZeneca, vacated HHS's December 2020 advisory opinion that the 340B statute compels drug manufacturers to offer 340B pricing when covered entities use contract pharmacies to dispense covered drugs to patients.

A federal district judge in Delaware yesterday rejected the U.S. Health and Human Services Department’s (HHS) position that its withdrawal of its December 2020 advisory opinion on 340B contract pharmacy rendered drug manufacturer AstraZeneca’s claims against the opinion moot.

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