FDA Law Blog

AUGUST 4, 2022

Kirschenbaum — In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS). July 25, 2022. Pfizer, Inc. Department of Health and Human Services et al.

Statute 98

Statute Mens Rea Manufacturing Court 98

FDA Law Blog

NOVEMBER 6, 2022

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. The Second Circuit’s Interpretation of the AKS and its Mens Rea Element.

Mens Rea 83

Mens Rea Statute Healthcare Manufacturing 83

LexForti

NOVEMBER 17, 2022

Teesha Deb (National Law University, Orissa). The author is associated to the National Law University, Orissa. Before establishment of this statute, there was the absence of any special law which could be entirely designated for the offenses perpetrated against minors. INTRODUCTION.

Statute 52

Statute Court Mens Rea Legal 52

JonathanTurley

JUNE 17, 2022

In past columns, we have discussed how Harvard Law professor Laurence Tribe seems intent upon running through the entire criminal code in declaring clear evidence of every federal crime by former President Donald Trump and/or his family. You don’t have to go to law school to know that there’s something seriously criminal about that.

Mens Rea 42

Mens Rea Law School Laws Felony 42