To embed, copy and paste the code into your website or blog:
On December 28, 2020, the District Court for the Northern District of California granted a motion for a preliminary injunction enjoining the Centers for Medicare and Medicaid Services from implementing the Most Favored Nation Rule (the “Rule”, summarized in our December 23 post) until the notice and comment procedures required by the federal Administrative Procedures Act (“APA”) are completed. The opinion, penned by Judge Chhabria, largely adopts the reasoning of the District Court for the District of Maryland, which granted a temporary restraining order against the implementation of the Rule last week. Judge Chhabria notes that the plaintiffs are “virtually certain” to prevail on their claim that the government violated the APA, and concludes that vacating the Rule in its entirety pending completion of the notice and comment period is the only appropriate path, as enjoining its enforcement as to the plaintiffs only runs contrary to the underlying purposes of the Rule itself. We will continue to monitor pending suits and other developments related to the Rule’s implementation.
To embed, copy and paste the code into your website or blog:
As we previously reported, in July 2019 the U.S. Department of Health and Human Services (HHS) announced a Safe Importation Action Plan (Action Plan) created with the FDA to allow the importation of certain prescription drugs originally intended for foreign markets, and particularly Canada. In the fall, the Trump administration announced implementation of the Action Plan (the “Final Rule”,
see 85 Fed. Reg. 62,094 (Oct. 1, 2020)). In response, on November 27, days before the Final Rule was to go into effect, Canadian Health Minister Patty Hadju signed an order to limit bulk exports of prescription drugs if they would create a shortage at home. Hadju stated that “[c]ompanies will now also be required to provide information to assess existing or potential shortages, when requested, and within 24 hours if there is a serious or imminent health risk.”