Healthcare, Manufacturing and Mens Rea

Search:

DAY

WEEK

MONTH

YEAR

Select your country:
Sign up | Log in

Healthcare

Manufacturing

Mens Rea

Could the Road to an AKS Violation Be Paved with Good Intentions? Pfizer Asks SCOTUS

FDA Law Blog

NOVEMBER 6, 2022

In its petition filed earlier this month, Pfizer challenges HHS’s interpretation of the AKS as “staggeringly overbroad,” contrary to the congressional intent behind the AKS, and a threat to “almost any activity that facilitates patient access to federally funded healthcare.” Background.

Mens Rea

Mens Rea Statute Healthcare Manufacturing

Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law Blog

AUGUST 4, 2022

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. Whether the Beneficiary Inducement Statute (BIS) is relevant to interpreting the AKS (essentially, no). Background. The Lesson of this Case.

Statute

Statute Mens Rea Manufacturing Court

Paralegal Brief

Could the Road to an AKS Violation Be Paved with Good Intentions? Pfizer Asks SCOTUS

Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

Stay Connected