FDA Law

MAY 7, 2025

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. The Court explained that the unsigned prescriptions sent to physicians are best understood as proposals for care, not as referrals. Mallory , 988 F.3d 3d 730 (4th Cir.

Referral 59

Referral Relationship Government Healthcare 59

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.

Manufacturing 52

Manufacturing Government Referral Provider 52

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.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83