The 21st Century Cures Act: Considering the Implications

Boston, MA—May 23, 2017—The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) held several sessions at its 22nd Annual International Meeting in Boston, MA, USA this afternoon that discussed regulatory and health policy implications of the 21st Century Cures Act.

The 21st Century Cures Act, passed in the United States in December 2016, is a wide-ranging law encompassing a variety of provisions “to accelerate the discovery, development, and delivery of 21st century cures.” Included among these provisions are instructions for the US Food and Drug Administration to consider real-world evidence as a potential factor in approval and labeling decisions.

The first session, Will the 21st Century Cures Act Drive Conduct of Pragmatic Clinical Trials? [IP12], was moderated by David Thompson, PhD, Senior Vice President, Real World Evidence, inVentivHealth, Manchester, MA, USA and included panelists:

  • Sean Tunis, MD, MSc, President and Chief Executive Officer, Center for Medical Technology Policy, Baltimore, MD, USA
  • Marc Berger, MD, Vice President, Real World Data and Analytic, Pfizer, Inc., New York, NY, USA

David Thompson, PhD opened the discussion by providing an overview of the US and European regulatory environments for real-world research. Sean Tunis, MD, MSc discussed how recent regulatory changes could provide impetus for the conduct of more pragmatic clinical trials by manufacturers. Marc Berger, MD highlighted the methodologic challenges and practical constraints that hinder adoption of this research design.

The second session, FDAMA Section 114 Has Been Replaced by Section 3037 of the Cures Act: Now What? [IP16], was moderated by Peter J. Neumann, ScD, Professor and Director, Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA. Panelists included:

  • Coleen Klasmeier, JD, Partner, Global Coordinator, Food, Drug and Medical Device Regulatory Practice Area Team, Sidley Austin LLP, Washington, DC, USA
  • Bryan Johnstone, PhD, Vice President, Evidence-Based Medicine, Sanofi US, Bridgewater, NJ, USA
  • Susan Cantrell, RPh, CAE, Chief Executive Officer, Academy of Managed Care Pharmacy, Alexandra, VA, USA

Section 3037 of the 21st Century Cures Act amends FDAMA Section 114 to provide greater flexibility in how drug companies communicate economic information to health plans. The legal and practical implications of this change, however, are unclear. Peter J. Neumann, ScD provided an overview of the history of FDAMA-114 and the scope of recent changes. Coleen Klasmeier, JD helped to interpret Section 3037 of the Cures Act and provided a legal perspective. Bryan Johnstone, PhD addressed potential implications of the changes for the biopharmaceutical industry, and Susan Cantrell, RPh, CAE discussed how this could impact the managed markets sector.

Additional information on the ISPOR 22nd Annual International Meeting can be found here. Released presentations from the conference can be found here. Interested parties can follow news at ISPOR’s press site and on social media using the conference hashtag #ISPORBoston.

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The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a nonprofit, international, educational and scientific organization that promotes health economics and outcomes research excellence to improve decision making for health globally.
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