In the US, prescription drug pricing is at the forefront of the national conversation. From the White House and Congress to news media and the general public, the debate continues about how to address the perceived issue of rising drug prices in America. With this discussion have come many legislative and regulatory policy proposals that, if implemented, could significantly change the way in which companies prepare for and respond to the marketplace throughout the drug product development and delivery life cycle.
This panel discussion will provide insights on policy proposals and actions put forward by the Presidential administration, Congress, and states, and their potential impacts to pharmaceutical regulatory strategy and decision-making. The session will take a deep dive into the various proposals offered, such as Canadian drug importation, foreign reference pricing, and inflationary caps. Further, the discussion will explore the potential implications of the November 2020 election on the future of drug development. The session will help participants understand and plan for potential policy actions on drug pricing and how these polices may impact their own regulatory strategies for bringing innovative, new treatment options to patients.
Describe the US political and regulatory drug pricing landscape.
Develop a working knowledge of proposed changes to the reimbursement marketplace to align with FDA policy on bringing new innovations to patients more efficiently.
Prepare regulatory strategies to interact with the drug pricing, payer, and coverage and reimbursement policy landscape.