Court Felony Manufacturing Mens Rea 
FDA Law Blog
NOVEMBER 6, 2022
Now, after an unfavorable HHS Office of the Inspector General (OIG) advisory opinion and two defeats in court, Pfizer has appealed the Second Circuit’s decision to the Supreme Court. The Second Circuit’s Interpretation of the AKS and its Mens Rea Element. Background.
FDA Law Blog
AUGUST 4, 2022
Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. 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.
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