Felony, Manufacturing and Mens Rea

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Felony

Manufacturing

Mens Rea

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). The Second Circuit’s Interpretation of the AKS and its Mens Rea Element. 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. Pfizer set the price of tafamidis at $225,000 for each one-year course of treatment.

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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