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Rachel Sachs (Former Academic Fellow)
Health Affairs Blog
November 23, 2020

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On Friday, the Trump Administration issued final versions of two drug pricing rules it had proposed years ago: the “most-favored-nations rule,” first proposed in October 2018 (summarized here), and the “rebate rule,” first proposed in January 2019 (summarized here). By issuing these rules in the final weeks of their administration, Trump Administration officials are claiming that they have fulfilled their most significant promises on prescription drug pricing. But the Administration has finalized the rules in a way that will create substantial legal jeopardy for them, and it is very likely that one or both will be invalidated on procedural grounds (to say nothing of the substantive or implementation challenges they will face).

In two posts, I review the key aspects of each rule and explain the major ways in which the rules have (and have not) been revised from their initial introductions in 2018 and 2019. I also explain the major procedural risks involved in the administration’s last-minute push for these rules, and situate those procedural risks against remaining substantive and implementation challenges each rule will face. This post addresses the most-favored nation interim final rule; a separate post discusses the rebate rule.

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health law policy   pharmaceuticals   rachel sachs