The Escalating U.S. Policy Environment Isha Bangia PhamD MBA Ulrich Neumann FRSA, MBA, MSC MA We would like to acknowledge the research of Maximilian Vargas, PhD MBA. Email: eva-bd@certara.com Legislative context Passed regulations • 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 rule- making 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

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