Drug Makers Want to Halt 340B Dispute Resolution Proceedings, Citing Lawsuits and Forthcoming Rule

Timeout
AstraZeneca and Sanofi have asked 340B administrative dispute resolution panels to pause covered entities’ ADR proceedings against them.

Drug manufacturers AstraZeneca and Sanofi have asked 340B administrative dispute resolution panels to pause covered entities’ ADR proceedings against them until all 340B-related federal court litigation is finished and until after the government finalizes its forthcoming new 340B ADR regulation.

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Feds Back and Kalderos Resists Pausing Company’s 340B Lawsuit

Kalderos says in a lawsuit that the federal government's 340B contract pharmacy policy is keeping it from effectively marketing its 340B Pay service to let drug companies provide 340B pricing as a post-purchase rebate rather than as a price discount.

The federal government told a judge in late December its appeal of her joint ruling in Novartis and United Therapeutics’ (UT) 340B contract pharmacy lawsuits justifies her pausing drug industry vendor Kalderos’ 340B contract pharmacy suit.

Kalderos told the judge

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Biden Axing Trump’s “Most Favored Nation” Drug Pricing Rule that 340B Entities and Pharma Both Disliked

The Biden administration is rescinding ex-President Trump's unimplemented most favored nation drug pricing rule, which was disliked by 340B entities and drug manufacturers.

The Biden administration is rescinding an unimplemented Trump-era regulation that would have pegged Medicare Part B drug reimbursement for 50 expensive, physician-administered drugs on the lowest price that drug manufacturers provide in similar countries.

The U.S. Centers for Medicare &

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Breaking News

Breaking News: AbbVie Becomes 11th Drug Maker to Restrict 340B Contract Pharmacy. Feds Appeal Rulings in Lilly, Novo Nordisk, and Sanofi Cases.

AbbVie will no longer offer voluntary 340B pricing on any of its orphan-designated drugs to covered entities subject to such exclusions.

Biopharmaceutical company AbbVie—maker of the expensive and widely prescribed immunosuppressive medication Humira—today became the 11th drug manufacturer to announce conditions on 340B pricing when contract pharmacies dispense medicines to patients.

Starting Feb. 1, AbbVie will require hospitals to submit claims

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Breaking News

Breaking News: Feds Appeal Rulings in Novartis and United Therapeutics 340B Contract Pharmacy Cases

The federal government yesterday asked the federal appeals court in Washington, D.C., to review a lower court's Nov. 5 joint ruling in Novartis and United Therapeutics' 340B contract pharmacy lawsuits.

The federal government late yesterday filed notice that it is appealing a federal judge’s joint ruling in two cases last month that halted enforcement actions against two drug companies that deny 340B pricing when hospitals and other health care providers

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John Thune, Senate’s No. 2 Republican and Strong 340B Provider Ally, Weighs Retirement

U.S. Senate Minority Whip John Thune (R-S.D.), a strong 340B covered entity ally, is considering not running for re-election in 2022. | Gage Skidmore/Flickr

South Dakota U.S. Sen. John Thune, the second-ranking Senate Republican and a long-time 340B covered entity ally, might not run for re-election in 2022, two news organizations report.  It would be a significant blow to 340B providers who have counted

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Citing Omicron Wave, 340B Coalition Weighs Making Winter Conference a Hybrid Live/Virtual Event

Citing concerns about COVID-19's Omicron variant, the 340B Coalition is considering turning its Jan. 31–Feb. 2 in-person winter conference into a hybrid in-person/virtual event.

The 340B Coalition said yesterday it is “actively exploring the potential for a hybrid [winter 2022] conference that would allow attendance in-person or virtually for those that cannot attend in-person.”

The coalition, composed of 13 groups that represent 340B covered

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N.Y. and Va. Health Centers Say Discovery Should Continue in their Novel 340B-Related Federal Lawsuit

The federal district court for western New York is hearing two 340B health centers' antitrust lawsuit against insulin and diabetes drug makers.

New York State and Virginia health centers asked a federal district judge on Monday to deny four insulin and diabetes drug manufacturers’ motion to pause fact-finding in the health centers’ antitrust suit stemming from the companies’ 340B contract pharmacy policies.

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Novo Nordisk and Sanofi Have Jan. 26 Deadline to File Opening Briefs in 340B Contract Pharmacy Appeal

The U.S. Third Circuit Court of Appeals will hear Novo Nordisk and Sanofi's 340B contract pharmacy lawsuits in tandem, just as a lower court did.

A federal appeals court in Philadelphia has given drug manufacturers Novo Nordisk and Sanofi a Jan. 26 deadline to file briefs seeking reversal of parts of a district judge’s Nov. 5 joint decision in the two companies’ 340B contract pharmacy

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Boehringer Ingelheim Extends 340B Contract Pharmacy Restrictions to Previously Exempt Specialty Drug Ofev

Boehringer Ingelheim extended its restrictions on 340B drug sales to hospitals to Ofev, its expensive specialty drug for idiopathic pulmonary fibrosis.

Drug manufacturer Boehringer Ingelheim (BI) this month extended its restrictions on 340B drug sales to hospitals to Ofev, its expensive specialty drug for idiopathic pulmonary fibrosis.

BI announced its new 340B pricing policy in late June. Effective Aug.

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