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FDA: Advancing Medical Innovation

The Bipartisan Policy Center’s new initiative – FDA: Advancing Medical Innovation – is developing viable policy options to reduce the time and cost associated with the discovery, development, and delivery of safe and effective drugs and devices for patients.

Overview and Goal

The goal of the Bipartisan Policy Center’s new initiative – FDA: Advancing Medical Innovation – is to identify viable policy options to advance medical innovation in the United States. Key areas of focus include:

  • Improving the time and cost associated with the development and delivery of safe and effective drugs and devices for patients;
  • Reviewing the scope of activities within the Food and Drug Administration (FDA);
  • Advancing a more efficient and effective regulatory framework for medical products;
  • Strengthening FDA’s ability to carry out its mission; and
  • Maintaining U.S. global leadership in medical innovation.

Project Outputs

Background Papers
BPC is authoring background papers on key issues surrounding medical innovation, including those defined above.

Policy Recommendations
BPC will publish viable policy recommendations derived from its research, interviews, roundtable discussions with a broad and diverse range of stakeholders, and deliberations of the initiative’s leadership and advisory committee.

Public Events
BPC will convene public events with panels of public and private leaders, experts, and stakeholders who will present their views on different policy options and ongoing legislative and regulatory activities.

Leadership and Advisory Committee

FDA: Advancing Medical Innovation Initiative is chaired by former Senate Majority Leader Bill Frist and co-chaired by former Representative Bart Gordon. Members of the advisory committee include Marc Boutin, Chief Executive Officer, National Health Council; Mark McClellan, MD, PhD, Director, Robert J Margolis Center for Health Policy, Duke University; Patrick Soon-Shiong, MD, Chairman and CEO, Institute for Advanced Health; and Andrew von Eschenbach, MD, President, Samaritan Health Initiatives. The initiative will also tap into the expertise and views of a broad range of experts and stakeholders through one-on-one meetings, roundtable discussions, and events. Janet Marchibroda, BPC’s Health Innovation Director, serves as the staff director for the effort.

Reports

Using Real-World Evidence to Accelerate Safe and Effective Cures
June 23, 2016

Advancing Medical Innovation for a Healthier America
July 24, 2015

Staff Analyses

Comparison of BPC Recommendations to Prescription Drug User Fee Act (PDUFA VI) Reauthorization, Senate Help Innovation Package,
and 21st Century Cures Act

August 16, 2016

10 Ways to Advance Medical Innovation This Year
March 3, 2016

BPC’s Technical Assistance Letter to the Senate HELP Committee
July 23, 2015

Events

Real World Evidence for Safe and Effective Cures: Medical Innovation for All Americans
June 23, 2015

Improving Health Through Interoperability and Information Sharing
December 8, 2015

Advancing Regenerative Cellular Therapies for Americans
December 2, 2015

Advancing Medical Innovation for a Healthier America
July 27, 2015

Advancing Medical Innovation Through Public Policy
March 16, 2015

In the News

New Sources of Health Care Data Can Accelerate Development of Safe and Effective Cures and Treatments
April 28, 2016

Bill Frist and Bart Gordon in The Hill: Time to pass medical innovation legislation
February 12, 2016

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