Category: Pharma Industry

HRSA Tells UCB its 340B Contract Pharmacy Policy Is Illegal

In Federal, Pharma Industry, RegulatoryJune 28, 2022370 Views

HRSA told drug manufacturer UCB yesterday its conditions on 340B pricing when hospitals use contract pharmacies are illegal and must stop or the company could face civil monetary penalties.

Federal healthcare officials told drug manufacturer UCB yesterday its restrictions on 340B pricing when covered entities use contract pharmacies are illegal and must stop or the company could face civil monetary penalties of up to $6,323.00 for each

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Gilead Adds 45-Day Lookback Clause to its 340B Contract Pharmacy Policy

In Pharma IndustryJune 24, 2022342 Views

Tom Mirga

Gilead had added 45-day time limits for replenishment orders and claims submissions under its 340B contract pharmacy restrictions on Harvoni and its other branded hepatitis C medicines.

Drug manufacturer Gilead on Wednesday added 45-day time limits for replenishment orders and claims submissions to its conditions on 340B pricing when covered entities use contract pharmacies.

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PhRMA and Private Oncology Practices Slam PBMs’ Role in 340B in Comments to FTC

In Federal, Pharma Industry, Regulatory, Trade AssociationJune 22, 2022193 Views

Laura Gilcrest

PhRMA and Community Oncology Alliance submitted comments to the FTC criticizing 340B contract pharmacies in response to the commission’s call for public input on PBMs’ business practices.

Drug makers and independent oncology practices slammed pharmacy benefit managers’ role in 340B contract pharmacy growth in recent public comment to the Federal Trade Commission.

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Bipartisan U.S. House Group Renewing Pressure on HHS to Punish Drug Makers Over 340B Pricing Denials

In Federal, Legislative, Pharma Industry, RegulatoryJune 16, 2022261 Views

Tom Mirga

Clockwise from top left, Reps. Abigail D. 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.) are urging fellow House members to sign a letter urging HHS to begin 340B enforcement actions against drug companies.

Six U.S. House members—three Democrats and three Republicans—are urging fellow representatives to sign a letter asking U.S. Health and Human Services (HHS) Department leaders “to begin enforcement actions against pharmaceutical companies that refuse to honor 340B discounts on

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NACHC Tells Merck its 340B Contract Pharmacy Policy for Health Centers Can Be Explained by “Only Greed”

In Pharma Industry, Trade AssociationJune 16, 2022190 Views

Tom Mirga

NACHC's president and CEO told her counterpart at Merck the company's decision to impose conditions on 340B on health centers, but not on other grantee covered entities, "cannot be explained by logic, only greed.”

The National Association of Community Health Centers this week strongly urged drug manufacturer Merck to eliminate “all conditions imposed on health centers to receive 340B price drugs at contract pharmacies.”

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Novartis and United Therapeutics File Briefs in Appeals Court in 340B Contract Pharmacy Lawsuits

In Federal, Judicial, Pharma IndustryJune 9, 2022255 Views

Tom Mirga

Novartis and United Therapeutics filed briefs last night in a federal appeals court in Washington, D.C., backing their right to impose conditions on 340B sales.

Drug manufacturers Novartis and United Therapeutics (UT) last night urged a federal appeals court in Washington, D.C., to affirm a lower court’s November 2021 judgement that the 340B statute does not stop manufacturers from attaching any conditions to

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Exelixis, Maker of Expensive Cancer Drugs, Is Latest Manufacturer to Impose 340B Contract Pharmacy Conditions

In News Alert, Pharma IndustryJune 8, 2022899 Views

Tom Mirga

California-based biopharmaceutical company Exelixis is the 17th drug manufacturer to impose conditions on 340B pricing when hospitals use contract pharmacies.

Biopharmaceutical manufacturer Exelixis yesterday became the 17^th drug maker to impose conditions on 340B pricing when hospitals use contract pharmacies.

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AstraZeneca and Sanofi Ask 340B ADR Panel to Dismiss Health Centers’ Overcharging Claims

In Federal, Pharma Industry, Regulatory, Trade AssociationJune 7, 2022354 Views

Tom Mirga

AstraZeneca and Sanofi asked a 340B administrative dispute resolution panel to dismiss NACHC’s claims its members are being overcharged due to the companies’ 340B contract pharmacies policies.

Drug manufacturers AstraZeneca and Sanofi have asked a 340B administrative dispute resolution panel to dismiss the National Association of Community Health Centers’ claims that its members are being overcharged due to the companies’ denied or restricted 340B sales

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GlaxoSmithKline Ending Voluntary 340B Pricing on Two Orphan Drugs

In Federal, Legislative, Pharma Industry, RegulatoryJune 7, 2022496 Views

Tom Mirga

GlaxoSmithKline is ending voluntary 340B pricing for rural and cancer hospitals on its blockbuster severe asthma drug Nucala and first-line advanced ovarian cancer drug Zejula.

In a blow to rural and cancer hospitals, U.K. drug manufacturer GlaxoSmithKline (GSK) is ending voluntary 340B pricing for them on its blockbuster severe asthma drug Nucala and first-line advanced ovarian cancer drug Zejula.

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Generic-drug Maker e5 Pharma Offering Refunds for 340B Overcharges

In Federal, Pharma Industry, RegulatoryJune 7, 202281 Views

Tom Mirga

e5 Pharma is giving 340B covered entities refunds for overcharges on six NDCs of the barbiturate phenobarbital during Q1 2021.

Generic drug maker e5 Pharma is giving 340B covered entities refunds for overcharges on six NDCs of the barbiturate phenobarbital during Q1 2021, according to a public notice on the U.S. Health Resources and Services Administration (HRSA) website.

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