Biden Wants to Let Medicare Negotiate Drug Prices, but Not Via His American Families Plan

President Biden applauds Vice President Kamala Harris and House Speaker Nancy Pelosi prior to his speech before a joint session of Congress last night. The event marked the first time in history that two women were seated in the two positions of authority and honor directly behind the president during such a speech. | @POTUS Twitter

President Biden has left out of his American Families human-capital investment plan drug pricing reforms that Democratic leaders in Congress have pressed him hard to add. House Speaker Nancy Pelosi (D-Calif.), House Energy and Commerce (E&C) Chair Frank Pallone (D-N.J.),

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Hospitals Could Get Another Shot to Intervene in AstraZeneca’s 340B Lawsuit

A federal judge in Delaware yesterday left the door open to letting hospital groups participate as third parties in a drugmaker’s lawsuit challenging the federal government’s 340B program contract pharmacy enforcement mechanisms. | Shutterstock

A federal judge in Delaware yesterday declined to add hospital groups as third parties to a drugmaker’s lawsuit challenging the federal government’s 340B program contract pharmacy enforcement mechanisms. But he left the door open to letting the groups participate as

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Will Biden’s American Families Plan Include an Rx Drug Pricing Measure?

There is a rift between President Biden and House Democrats over whether to include provisions to lower drug prices in his American Families plan, or deal with drug pricing later in another bill. | Official White House Photo by Adam Schultz

President Biden might exclude legislation to reduce what consumers and the federal government pay for prescription drugs from his American Families human and capital investment initiative, news organizations report this morning. Biden is scheduled to describe his infrastructure investment plan

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Breaking News

BREAKING: Judge Nixes Hospital Groups’ Participation in AstraZeneca’s 340B Contract Pharmacy Case

Six hospital groups cannot participate as third parties in drug manufacturer AstraZeneca’s lawsuit against the government over its 340B contract pharmacy requirements, a judge ruled this morning in federal district court in Wilmington, Del. (pictured).

A federal district judge in Wilmington, Del., ruled this morning that six hospital groups cannot participate as third parties in drug manufacturer AstraZeneca’s lawsuit against the government over its 340B contract pharmacy requirements.

In a ruling delivered from the bench,

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340B Providers Escape Bullet in House Dem Rx Bill, but Not in GOP Version

U.S. House E&C Chair Frank Pallone this morning re-introduced a major drug pricing bill from the last session of Congress, minus language from last year's version strongly opposed by 340b covered entities. | C-SPAN

UPDATE Thursday, April 22, 2021, 1:00 p.m. EDT—U.S. House Energy and Commerce (E&C) Chair Frank Pallone this morning introduced a significantly slimmed-down version of H.R. 3, the drug pricing bill that the House passed during the last session of Congress

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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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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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