Category: Federal

Key Congressional Committee Urges HRSA to Fine Drug Makers Over 340B Contract Pharmacy Denials

In Federal, LegislativeJuly 15, 2021492 Views

U.S. House appropriators are encouraging HRSA to use fines and "any available measures" to hold drug manufacturers accountable for withholding 340B drug discounts.

The U.S. House Appropriations Committee is pleased with the U.S. Health Resources and Services Administration (HRSA) for challenging six drug makers’ denials of 340B pricing when covered entities use contract pharmacies, the committee said in a report released yesterday. It …

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

Tom Mirga

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 …

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, 2021144 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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Rosen Introduces Bill to Boost Nonprofit Drug Makers’ Competitiveness

In Federal, Legislative, Pharma IndustryJuly 13, 202187 Views

Ron Shinkman

U.S. Sen. Jacky Rosen's (D-Nev.) bill, S. 2257, is aimed at boosting nonprofit drug companies' competitiveness.

U.S. Sen. Jacky Rosen (D-Nev.) has introduced legislation to help nonprofit drug companies compete in the market with their for-profit counterparts.

Rosen’s bill S. 2257, the Expanding Access to Affordable Prescription Drugs and Medical Devices Act, would make it simpler

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News Alert: Bipartisan Bill Introduced to Protect 340B Providers From Reimbursement Cuts and Address Duplicate Discount Challenge

In Federal, LegislativeJuly 9, 2021992 Views

Ted Slafsky

Reps. David McKinley (R-WV) and Abigail Spanberger (D-VA) introduced legislation today to address so called pickpocketing of 340B provider savings and establish a clearinghouse to address duplicate discounts.

Reps. David McKinley (R-WV) and Abigail Spanberger (D-VA) introduced the PROTECT 340B Act today, which would prohibit pharmacy benefit managers (PBMs) and other third-party payers from paying 340B providers below-market rates or engaging in other perceived discriminatory contracting practices. While …