BPC launches innovation initiative

The Bipartisan Policy Center has launched its five-point "FDA: Advancing Medical Innovation" initiative, to develop viable policy options to reduce the time and cost associated with the discovery, development and delivery of safe and effective drugs and medical devices to patients.

The initiative is chaired by former Senate Majority Leader Bill Frist and co-chaired by former Congressman Bart Gordon. Members of the advisory committee include Marc Boutin, CEO of the National Health Council; Mark McClellan, MD, PhD, senior fellow and director, Health Care Innovation and Value Initiative, Engelberg Center for Health Care Reform, Brookings Institution; and Patrick Soon-Shiong, MD, chairman and CEO, Institute for Advanced Health.

Speaking during the initiative's kick-off event on March 16, Frist said "Our inefficient, less-than-modern, drug discovery and device approval process drives up cost and delays treatment. We must accelerate the process of getting safe and effective drug and medical devices to patients."

The last major update to the authorizing statute for the FDA was 18 years ago, Frist said. The technological advances in aggregating and analyzing patient data "really don't fit, at least in a good way, into a 20th-century regulatory framework," he said.

The organizers listed the following five key areas of focus:

• Improving the time and cost associated with the discovery, development and delivery of safe and effective drugs and devices for patients;
• Reviewing the scope of activities within the 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.

BPC is authoring background papers on key issues surrounding medical innovation, including those defined above and will publish viable policy options 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. They also plan to convene public events where a range of stakeholders will present their views on different policy options and ongoing legislative and regulatory activities.