Criminal Law, Laws, Manufacturing and Mens Rea

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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). In June 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Background.

Mens Rea

Mens Rea Statute Healthcare Manufacturing

Amid overdose crisis, court will weigh physician intent in “pill mill” prosecutions and more under the Controlled Substances Act

SCOTUSBlog

FEBRUARY 28, 2022

United States , may appear to be an ordinary “pill mill” case, the decision could have a much broader impact on the practice of medicine as well as doctrines of criminal intent. The government argues, in contrast, that the physician must show she has made an “ objectively reasonable good-faith effort to learn and comply with medical norms.”

Mens Rea

Mens Rea Court Government Manufacturing

Paralegal Brief

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

Amid overdose crisis, court will weigh physician intent in “pill mill” prosecutions and more under the Controlled Substances Act

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