FDA Law

AUGUST 4, 2022

On June 27, 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. That court granted summary judgment to the government on the APA claim and rejected Pfizer’s narrower reading of the AKS, which would require an element of “corrupt” intent to impose AKS liability.

Manufacturing 98

Manufacturing Medical Government IT 98

FDA Law

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

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. It was alleged that other employees administered the medication to patients even after observing signs of tampering, although no patients were reported harmed.

Board-Certified 52

Board-Certified Provider Government Management 52

FDA Law

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. The preamble notes that this information would help ensure that drugs are being used for approved or otherwise medically accepted indications. See 42 U.S.C.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59