Articles by : Tom Mirga, Editor at Large

Bipartisan U.S. House Group Wants HHS to Start Punishing Drug Makers Over 340B Pricing Denials

January 25, 2022 Tom Mirga, Editor at Large Views

headshots of U.S. House leaders Spanberger, Axne, McKinley, Matsui, Katko, Johnson

Clockwise from top left, U.S. Reps. Abigail Spanberger (D-Va.), Cindy Axne (D-Iowa), David McKinley (R-W.Va.), Doris Matsui (D-Calif.), John Katko (R-N.Y.), and Dusty Johnson (R-S.D.) asked HHS “to move quickly to enforce the law and begin assessing civil monetary penalties on manufacturers that have denied 340B pricing to providers.”

Three Democratic and three Republican U.S. House members asked the U.S. Health and Human Services Department (HHS) on Friday “to move quickly to enforce the law and begin assessing civil monetary penalties on manufacturers that have denied 340B pricing to

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Health Center Opposes AstraZeneca’s Motion to Pause 340B Dispute Resolution Proceedings Over Company’s Contract Pharmacy Policy

January 25, 2022 Tom Mirga, Editor at Large Views

A Vermont health center asked a 340B dispute resolution panel to reject AstraZeneca's motion to stay the proceedings.

A Vermont community health center that co-initiated 340B administrative dispute resolution (ADR) proceedings against AstraZeneca over its conditions on 340B contract pharmacy yesterday asked the panel hearing its claim to deny the drug company’s motion to stay the proceedings.

Little

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FDA OKs COVID-19 Drug Veklury (remdesivir) for Outpatients, Opening the Way for 340B Pricing

January 25, 2022 Tom Mirga, Editor at Large Views

Hospitals are expressing relief over being able to administer the COVID-19 drug Veklury in outpatient settings and to be able to buy it finally at a 340B price.

Hospitals caring for patients infected with the highly infectious omicron variant of COVID-19 say they are very relieved to be getting 340B pricing finally on Gilead’s injectable antiviral medication Veklury (remdesivir).

On Friday, the U.S. Food and Drug Administration (FDA)

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PhRMA and Arkansas Seek Faster Court Ruling on State’s Novel 340B Contract Pharmacy Law

January 21, 2022 Tom Mirga, Editor at Large Views

PhRMA and the state of Arkansas have agreed on a plan that could lead the federal district court in Little Rock to rule sooner than now anticipated on the state’s law protecting 340B contract pharmacy arrangements.

The brand name drug industry and the state of Arkansas have agreed on a litigation plan that could lead to a quicker federal court decision than now anticipated on the state’s one-of-a-kind law protecting 340B contract pharmacy arrangements.

Pharmaceutical Research

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AHA Asks Congress to Attach 340B Hospital Protections to Must-Pass Spending Bill

January 21, 2022 Tom Mirga, Editor at Large Views

The House Appropriations Committee approved the Labor, Health and Human Services, Education and Related Agencies Appropriations Act on July 10.

The American Hospital Association (AHA) yesterday asked U.S. House and Senate party leaders to ensure that a must-pass spending bill next month protects hospitals from losing their 340B eligibility due to changes in patient and payer mix caused by the

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Three Drug Makers, Including Two with Contract Pharmacy Restrictions, Post 340B Refund Notices

January 21, 2022 Tom Mirga, Editor at Large Views

Bristol Myers Squibb, Novo Nordisk, and Ipsen Biopharmaceuticals notified 340B covered entities this week about refunds for charges above 340B ceiling prices.

Three drug manufacturers—including two that have imposed conditions on 340B contract pharmacy—posted public notices this week to 340B covered entities about refunds for charges above 340B ceiling prices.

Bristol Myers Squibb (BMS) and Novo Nordisk’s notices came to light yesterday

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Democrats Weigh Passing Build Back Better Act—Possibly Including Drug Pricing Reforms—in “Chunks”

January 21, 2022 Tom Mirga, Editor at Large Views

New CBO findings on brand drug price increases “drive home the urgent need to pass robust drug pricing reforms," U.S. Senate Finance Committee Chair Ron Wyden (D-Ore.) said this week.

U.S. Senate Finance Committee Chair Ron Wyden (D-Ore.) said this week that new Congressional Budget Office (CBO) findings on brand drug price increases “drive home the urgent need to pass robust drug pricing reforms.”

“The average net price for brand-name

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Groups and Individual Health Care Providers Grapple with BMS’s New 340B Contract Pharmacy Policy

January 19, 2022 Tom Mirga, Editor at Large Views

Individual 340B covered entities are deciding how to respond to the multi-point 340B contract pharmacy policy that Bristol Myers Squibb (BMS) released last Friday.

Groups that represent 340B hospitals yesterday slammed the multi-point 340B contract pharmacy policy that Bristol Myers Squibb (BMS) released last Friday.

Representatives of grantee covered entities, which BMS exempted from its contract pharmacy restrictions involving most of its products, overwhelmingly

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With Judge in Astra 340B Case About to Get Promotion, What Will Happen to the Highly Anticipated Case?

January 19, 2022 Tom Mirga, Editor at Large Views

The U.S. Senate could elevate Leonard Stark, the federal judge who has presided over AstraZeneca’s 340B contract pharmacy lawsuit, to a federal appeals court as soon as the end of this week.

Leonard Stark, the federal judge who presided over AstraZeneca’s 340B contract pharmacy lawsuit from its start last year, is on the verge of being elevated to a higher court, possibly by the end of this week. If that happens before

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With Public Health Emergency Extended, 340B Flexibilities to Continue

January 19, 2022 Tom Mirga, Editor at Large Views

340B program flexibilities will continue for another 90 days under the latest extension of the COVID-19 national public health emergency.

340B program flexibilities will continue under the eighth 90-day extension of the COVID-19 national public health emergency (PHE) late last week.

U.S. Health and Human Services (HHS) Secretary Xavier Becerra renewed the PHE on Friday, Jan. 14.

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