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

FDA Law Blog

In June 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Pfizer challenged the OIG’s interpretation as contrary to law in a lawsuit brought in the Southern District of New York (SDNY). The Second Circuit’s Interpretation of the AKS and its Mens Rea Element.

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

SCOTUSBlog

They also argue that Congress, elsewhere in the CSA, meaningfully deviated from the “knowingly or intentionally” language to impose a lower standard for certain actions undertaken “knowingly or recklessly,” thereby showing that Congress knew how to criminalize merely reckless behavior when it wanted to.