Feds Asks Courts to Reject Lilly and Sanofi’s 340B “Self-Help”

Lawyers for HHS have asked federal courts in Indianapolis (above) and New Jersey to dismiss 340B-related lawsuits against the department brought by drugmakers Eli Lilly and Sanofi.

U.S. Justice Department (DOJ) lawyers asked federal district courts in Indiana and New Jersey this week to condemn, not condone, drugmakers Eli Lilly and Sanofi’s “extra-statutory self-help efforts to rewrite” the 340B statute “under the guise of ‘program integrity’” and

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Hospital Groups Ask HHS to Start Fining Pharma Over 340B Pricing Denials

Hospital groups want HHS Secretary Xavier Becerra to impose civil fines on six drug companies for refusing to offer 340B discounts on drugs dispensed by contract pharmacies. | Gage Skidmore

Six hospital groups asked U.S. Health and Human Services (HHS) Secretary Xavier Becerra on Tuesday to state “immediately and definitively” that six drug manufacturers’ refusals to offer 340B discounts on drugs dispensed by contract pharmacies are illegal.

They also asked

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Kalderos: 3-5% of 340B Discounts and Medicaid Rebates Are Duplicates

Drug industry vendor Kalderos says duplicate 340B discounts and Medicaid rebates cost the industry between $933 million and $1.6 billion in 2019.

Between 3% and 5% of 340B drug discounts and Medicaid drug rebates are duplicates, adding up to at least $933 million and potentially as high as $1.6 billion in additional costs to the pharmaceutical industry in 2019, according to new

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Congress Passes Bills Aimed at Boosting Generics and Biosimilars

Congress has sent President Biden two bills to boost generic and biosimilar drugs. Generics are exact copies and biosimilars are highly similar to original brand products. | Shutterstock

UPDATED Monday, April 26, 2021, 9:00 a.m. EDT—President Biden signed the two bills into law on April 23.

The U.S. House of Representatives passed two bills last week intended to reduce the overall costs of medications by boosting competition for

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CBO Report: R&D Costs Do Not Influence Pharma Pricing

A prescription drug's sunk R&D costs do not influence the drug's price, the Congressional Budget Office found.

The pharmaceutical industry’s spending on research and development as a proportion of its revenue dwarfs virtually all other manufacturing sectors, but those costs do not really impact pricing, according to a new analysis by the Congressional Budget Office.

Drugmakers

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HHS Tells Judge 340B Dispute Resolution Is Back on Track and It Is Weighing Other Pharma Enforcement Steps

The U.S. Health and Human Services Department (HHS) can “move forward with implementing” the stalled 340B administrative dispute resolution (ADR) process, and it is “actively considering additional options for agency enforcement of the 340B statute” against drug manufacturers denying 340B

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AstraZeneca Tells Court: Congress Didn’t Make 340B to Generate Profits for Providers

AbbVie and AstraZeneca filed a pair of lawsuits to block Minnesota's law barring manufacturer 340B contract pharmacy restrictions.

Congress never intended for safety-net health care providers to make money by buying prescriptions drugs at a discount through the 340B program and billing payers at above the drugs’ acquisition cost, drug manufacturer AstraZeneca (AZN) told a federal district court

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Public Relations War Over 340B’s Intent Intensifies

The debate over 340B’s purpose recently spilled over into a Boston newspaper and nationally.

In a March 30 op-ed in the Boston Herald, Peter Pitts, a former U.S. Food and Drug Administration (FDA) official under President George W. Bush

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24 Health Systems List 8 Ways HHS Can Stabilize 340B Without Involving Congress

Ending the deep cut in 340B hospitals' Medicare drug reimbursement topped two dozen health systems' list of 340B recommendations for HHS Secretary Xavier Becerra. | C-SPAN

Twenty four large health systems with hospitals in the 340B program yesterday sent U.S. Health and Human Services (HHS) Secretary Xavier Becerra eight recommendations “to stabilize this program for the long-term” that he could implement without involving Congress.

The coalition,

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BREAKING: Key GOP U.S. Senator Presses HHS Deputy Secretary Nominee to Take Action on 340B

Andrea Palm, President Biden's pick to be HHS Deputy Secretary, indicated in response to a question during her confirmation hearing today that "there are things [HHS] can and needs to be doing" about 340B hospitals' complaints about drugs manufacturers and PBMs.

Andrea Palm, President Biden’s pick to be the number two official at the U.S. Health and Human Services Department (HHS), pledged during her U.S. Senate confirmation hearing this morning to make sure that the 340B program “is working as it

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