Becerra Extends COVID-19 Public Health Emergency Through Mid-January

The COVID-19 national public health emergency (PHE) has been extended for a seventh time, to Jan. 13, 2022.

U.S. Health and Human Services (HHS) Secretary Xavier Becerra on Friday extended the COVID-19 national public health emergency (PHE) for a seventh 90-day period.

Becerra’s Oct. 15 declaration means the PHE will last until Jan. 13, 2022, unless terminated

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340B Report Publisher and CEO: If Congress Flips Next Year, Expect 340B To Get A Very Close Look

Ted Slafsky
If Congress changes hands during next year’s mid-term elections, expect a renewed effort to place significant restrictions on the 340B program, 340B Report Publisher and CEO Ted Slafsky predicts.

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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News Alert: Judge Denies Sanofi Stay Against 340B ADR Proceedings, as Stakeholders Brace for Coming Whirlwind of Crucial Decisions in 340B Cases

A federal district judge yesterday denied Sanofi's emergency request for a stay against 340B ADR proceedings, in part because she said she will rule in Sanofi's 340B contract pharmacy lawsuit on or before Nov. 5.

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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In Important Development, HHS Close to Rescinding Trump-era Rule that Undercuts its Sub-Regulatory Power

HHS is poised to rescind Trump administration regulations that have added to doubt about the authority of HHS guidance documents, including for 340B.

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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A Closer Look at Critical Court Hearing on 340B Contract Pharmacy Legality

A federal district court in Washington, D.C., heard arguments this week in Novartis and United Therapeutics' 340B contract pharmacy lawsuits.

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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Feds Oppose Sanofi’s Request for Emergency Protection Against 340B ADR Proceedings

The federal government yesterday opposed Sanofi's request to a judge to grant it emergency protection from 340B dispute resolution proceedings.

The federal government yesterday asked a federal district judge to deny drug manufacturer Sanofi’s request for emergency protection from being brought before a 340B administrative dispute resolution panel.

Sanofi asked the judge for an emergency stay last week. The

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Drug Manufacturers May Seek Orphan Designations to Avoid Paying 340B Discounts, HHS OIG Concludes

The 340B orphan drug exclusion incentivizes manufacturers to get orphan designations for drugs approved to treat common diseases or conditions, a new government report says.

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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Judge Expresses Doubt About Government’s Position During Arguments in Novartis and United Therapeutics’ 340B Contract Pharmacy Lawsuits

U.S. District Judge Dabney Friedrich said today she agreed with another federal judge that the plain text of the 340B statute "doesn't speak" to contract pharmacy.

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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Lifting of Title X Gag Rule Could Spur Hundreds of Clinics to Rejoin 340B

A September 2019 protest in Cleveland against the Trump administration rule barring Title X-funded family clinics from providing abortion referrals.

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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Feds Have Until Tomorrow to Oppose Sanofi’s Request for Stay Against 340B ADR Proceedings

U.S. Chief District Judge Freda Wolfson gave government lawyers until the end of the day tomorrow to weigh in on Sanofi’s request for emergency protection from 340B ADR proceedings.

A federal district judge has given government lawyers until Wednesday to weigh in on drug manufacturer Sanofi’s request for emergency protection from being brought before a 340B administrative dispute resolution panel.

U.S. Chief District Judge Freda Wolfson gave the U.S.

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