FDA Law

MAY 7, 2025

The Seventh Circuit took a more lenient approach than the Fourth Circuit, focusing its rationale on whether an independent contractor had improper influence over a healthcare providers independent healthcare decisions. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th

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Referral Relationship Government Healthcare 59

FDA Law

NOVEMBER 6, 2022

Pfizer manufactures tafamidis (sold under brand names Vyndaqel and Vyndamax), a breakthrough treatment for a rare, progressive heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). At the center of Pfizer’s argument is whether an AKS violation requires corrupt intent. Background. Borrasi, 639 F.3d 3d 774 (7th Cir.

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Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

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Manufacturing Government Referral Provider 52

Annals of Family Medicine

NOVEMBER 20, 2024

Context: The ExPAND Mifepristone (ExPAND) learning collaborative is a year-long program focused on growing the pool of abortion providers by integrating medication abortion into primary care. Objectives: 1) Participating clinics begin to provide mifepristone for early pregnancy loss (EPL) and/or abortion care.

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Primary Care Clinic Referral Provider 130

FDA Law

MARCH 31, 2025

C) REMEDIES IN ADDITION.Remedies provided in this paragraph are in addition to, and not in lieu of, any other remedy provided by Federal law. Under the Seventh Amendment and Jarkesy , a jury trial must be provided on liability before civil monetary penalties that are legal in nature can be assessed.

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FDA Law

APRIL 2, 2025

C) REMEDIES IN ADDITION.Remedies provided in this paragraph are in addition to, and not in lieu of, any other remedy provided by Federal law. Under the Seventh Amendment and Jarkesy , a jury trial must be provided on liability before civil monetary penalties that are legal in nature can be assessed.

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Consulting Manufacturing Referral IT 59