FDA Law Blog
AUGUST 4, 2022
Kirschenbaum — In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS). The Second Circuit’s Interpretation of the Anti-Kickback Statute. Pfizer, Inc.
FDA Law Blog
NOVEMBER 6, 2022
Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. The Second Circuit’s Interpretation of the AKS and its Mens Rea Element.
The IP Law Blog
MARCH 2, 2021
es the threat posed to companies that rely on third-party manufacturers. Considering the importance of Chinese manufacturing to global trade, the Chinese legal system and its evolving trademark enforcement system will likely cause companies to get creative. 7 While the statute makes willfulness a prerequisite to a pro?ts
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