Articles by : Tom Mirga, Editor at Large

News Alert: Pfizer Becomes the 13th Drug Maker to Limit 340B Contract Pharmacies

January 28, 2022 Tom Mirga, Editor at Large Views

Pfizer is the 13th drug manufacturer to impose conditions on 340B sales of prescription drugs involving contract pharmacies.

UPDATE Friday, Jan. 28, 2022, 3:25 p.m.—The U.S. Health Resources and Services Administration (HRSA) said this afternoon it is reviewing Pfizer’s policy and will evaluate next steps as needed.

Pfizer today became the 13^th drug manufacturer to impose conditions on

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Exclusive: Nearly Five Years Before BMS Voluntarily Opened Up Myeloma Drug Network, HRSA Told Celgene it “Must Ensure” Entities Could Buy at 340B Price

January 27, 2022 Tom Mirga, Editor at Large Views

Bristol Myers Squibb said Jan. 14 it voluntarily will let 340B covered entities buy Revlimid, Pomalyst, and Thalomid at the 340B ceiling price through specialty pharmacies in the company's limited distribution network for the drugs. BMS acquired the drugs in 2019 when it acquired Celgene. In 2017, HRSA told Celgene it had to ensure that 340B entities could buy the drugs at 340B price through the same limited distribution network.

The U.S. Health Resources and Services Administration (HRSA) told drug manufacturer Celgene nearly five years ago the company “must ensure” that covered entities could buy its cancer drugs Revlimid, Pomalyst, and Thalomid at the 340B ceiling price through Celgene’s limited

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Novo Nordisk Will Let Hospitals Designate Two 340B Contract Pharmacies—one Retail and one Specialty

January 27, 2022 Tom Mirga, Editor at Large Views

Novo Nordisk has amended its policy restrictions on 340B drug sales to hospitals. Starting Feb. 1, it will let those lacking wholly owned contract pharmacies to designate two contract pharmacy locations—one retail and one specialty.

Drug manufacturer Novo Nordisk has amended its policy restrictions on 340B drug sales to hospitals involving shipments to contract pharmacies.

In a notice to covered entities dated Jan. 24, Novo Nordisk said if a 340B hospital covered entity “does

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In a Relief to Rural Providers, Gilead Is Waiving 340B Orphan Drug Exclusion for its COVID-19 Drug Veklury

January 27, 2022 Tom Mirga, Editor at Large Views

Gilead says it will voluntarily extend 340B pricing to critical access hospitals, sole community hospitals, and rural referral centers on Veklury (remdesivir), its injectable antiviral treatment for COVID-19.

Drug manufacturer Gilead will voluntarily extend 340B pricing to critical access hospitals, sole community hospitals, and rural referral centers on Veklury (remdesivir), its injectable antiviral treatment for COVID-19, the company said late Tuesday.

The U.S. Food and Drug Administration (FDA)

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Hospitals Taking Heavy Losses Due to Drug Company Limits on 340B Pricing, Survey Says

January 27, 2022 Tom Mirga, Editor at Large Views

340B Health says a new survey of its members shows 340B hospitals “are losing significant resources” due to drug companies’ conditions on 340B pricing when covered entities use contract pharmacies.

UPDATE Friday, Jan. 28, 2022—This story was updated to include comments by Pharmaceutical Research and Manufacturers of America (PhRMA.)

340B hospitals “are losing significant resources” due to drug companies’ conditions on 340B pricing when covered entities use contract pharmacies, according

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Vizient Asks Congress to Pass Senate Version of Bill to Protect Hospitals from Losing 340B Eligibility During Pandemic

January 27, 2022 Tom Mirga, Editor at Large Views

Vizient asked Congress to pass the U.S. Senate version of bipartisan legislation to protect hospitals from losing their 340B eligibility due to changes in patient and payer mix caused by the COVID-19 pandemic.

Health care services and group purchasing company Vizient asked Congress on Monday to pass the U.S. Senate version of bipartisan legislation to protect hospitals from losing their 340B eligibility due to changes in patient and payer mix caused by the

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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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