The Escalating U.S. Policy Environment

Apr 06, 2021

In the 2020 campaign for the US White House, the pharmaceutical industry had become a prime target of bipartisan outrage. We should note that the healthcare debate’s focus on drug costs and pricing processes is not new – it has been a matter of public debate for over thirty years. The recent inflation of regulatory rulemaking in Washington and the degree of disruption likely to be caused by key legislative proposals, are seen by many as historically unprecedented. With the so-called “Blueprint”, the Trump Administration released an aggressive set of drug pricing reform concepts in May 2018 aiming to combine volume control with limitations on branded drug spending followed by rule-making activity at unforeseen levels. Several regulatory proposals are still under debate, and some have been withdrawn following public comment periods. By many accounts, one of the most disruptive and the furthest progressed towards becoming law is the International Pricing Index Proposal (IPI) that seeks to peg Part B prices on averaged Ex-US prices. It is currently pending under OMB.

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