FDA Law Blog

NOVEMBER 6, 2022

In June 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. The Court found that there is at best little utility in interpreting the AKS by reference to the BIS. The Medicare program would pay most of the remaining $225,000 in annual cost. Pfizer’s Petition to SCOTUS.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law Blog

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. See 42 U.S.C.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

FDA Law Blog

SEPTEMBER 13, 2021

A May 2019 CMS final rule that would have required drug TV advertisements to disclose the WAC of the drug was challenged by a group of pharmaceutical companies and vacated on statutory grounds by the D.C. Medicare negotiation authority; encourage biosimilars and generic drug utilization).

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98