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The Politics of Innovation and Cost: The Impact of the Biden Administration’s Cadence on Manufacturer Pipelines, Product Launches and Pricing Strategies

June 20, 2024 8:15am

2024 Conference Chair

Deirdre Parsons
Head & Senior Director, Public Policy & Government Relations
Alnylam Pharmaceuticals

Hans Sauer
Deputy General Counsel, VP of IP
Biotechnology Innovation Organization

Maureen A. Bresnahan
Assistant General Counsel
Eisai Inc.

Christine Baeder
President
Apotex Corp. US

Eva Temkin
Partner | Chair of FDA Practice
Paul Hastings LLP

This opening session will examine how the Biden Administration’s efforts to improve access to medication are reshaping the landscape for research institutions and manufacturers, influencing their portfolios, product launch timelines, pricing strategies, and ultimately, market access. Topics of discussion will include:

  • Exploring recent and proposed legislation designed to improve access to therapies and lower drug prices:
    • The price control provisions of Inflation Reduction Act (IRA)
    • Ensuring Pathways to Innovative Cures (EPIC) Act
    • Preserve Access to Affordable Generics and Biosimilars Act 2023
    • Proposed march-in rights expansion under Bay Doyle Act
    • Biosimilar Red Tape Elimination Act
  • Reading the tea leaves of the lawsuits challenging the price control provisions of the Inflation Reduction Act
  • Reviewing the drugs currently selected for price negotiation with CMS
  • Revisiting the COVID-19 vaccine waivers and lawsuit