FDA Law Blog
AUGUST 4, 2022
On June 27, 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. 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.
FDA Law Blog
NOVEMBER 6, 2022
In June 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. The Court found that there is at best little utility in interpreting the AKS by reference to the BIS. The Medicare program would pay most of the remaining $225,000 in annual cost. Pfizer’s Petition to SCOTUS.
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FDA Law Blog
FEBRUARY 2, 2023
Alternative methods will require significant research investment to demonstrate their utility for a particular context of use and inform regulatory decision-making. In 2019, FDA formed an agency-wide Alternative Methods Working Group indicating that it viewed the applicable scope of alternative methods to go beyond just toxicology research.
FDA Law Blog
JUNE 22, 2022
This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. Department of Justice (“DOJ”), Sovah Health to Pay United States $4.36 Million to Settle Claims of Controlled Substance Act Violations (June 8, 2022).
FDA Law Blog
JUNE 2, 2023
Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. See 42 U.S.C.
FDA Law Blog
SEPTEMBER 13, 2021
A May 2019 CMS final rule that would have required drug TV advertisements to disclose the WAC of the drug was challenged by a group of pharmaceutical companies and vacated on statutory grounds by the D.C. Medicare negotiation authority; encourage biosimilars and generic drug utilization).
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