Felony, Manufacturing, Mens Rea and New York

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Felony

Manufacturing

Mens Rea

New York

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

FDA Law Blog

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). Pfizer challenged the OIG’s interpretation as contrary to law in a lawsuit brought in the Southern District of New York (SDNY).

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. Pfizer challenged the Agency’s interpretation as contrary to law under the Administrative Procedure Act (APA) in the Southern District of New York. 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

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