Pharmaceutical Research and Manufacturers of America told a federal district judge last week that the federal government has failed to refute PhRMA’s contention that the regulation establishing the 340B administrative dispute resolution (ADR) process “is unconstitutional, procedurally defective, and relies
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If Congress changes hands during next year’s mid-term elections, we can expect the 340B program to be back under the spotlight with a renewed effort to place significant restrictions on the program, 340B Report Publisher and CEO Ted Slafsky writes
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A federal district judge in New Jersey has denied drug manufacturer Sanofi’s emergency motion for a stay against 340B administrative dispute resolution (ADR) proceedings—in part because she said she will hand down her decision in Sanofi’s 340B contract pharmacy lawsuit
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The U.S. Health and Human Services Department (HHS) is poised to rescind Trump administration regulations that have added to doubt about the authority of HHS guidance documents, including those for the 340B program.
During the Trump administration, the U.S Health
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U.S. District Judge Dabney Friedrich all but told the federal government during a court hearing in Washington, D.C., on Tuesday she rejects its basic argument that the plain text of the 340B statute requires drug manufacturers to honor 340B purchases
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The ban on 340B discounts on orphan drugs for rural and free-standing cancer hospitals may give drug companies a powerful incentive “to seek orphan designation for drugs approved to treat common diseases or conditions,” the U.S. Health and Human Services
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A federal district judge said today she “has a hard time following” the federal government’s argument that the 340B statute requires drug manufacturers to honor covered entities’ drug purchases no matter how entities choose to distribute the medicines.
“It seems
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Hundreds of family planning clinics that lost their Title X federal grants and 340B eligibility because they opposed a Trump-era rule barring them from providing abortion referrals might return to Title X and 340B soon.
The U.S. Department of Health
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