Tuesday, December 29, 2020
On 23 December 2020, Judge Catherine Blake of the U.S. District Court for the District of Maryland granted the Pharmaceutical Research and Manufacturers of America (PhRMA) a 14-day nationwide temporary restraining order, preventing the Centers for Medicare and Medicaid Services (CMS) from implementing and enforcing its Most Favored Nation (MFN) interim final rule (MFN Rule) scheduled to take effect on 1 January 2021.
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On 28 December 2020, in a parallel case and specifically adopting the reasoning in Judge Blake’s order, Judge Vince Chhabria of the U.S. District Court for the Northern District of California granted California Life Sciences Association (CSLA) a preliminary injunction prohibiting CMS from implementing the MFN Rule based on a failure to follow notice and comment procedures under Administrative Procedure Act (APA). Most notably, Judge Chhabria’s order vacates the MFN Rule in its entirety pending completion of the notice and comment process under the APA.