Wednesday, March 30, 2011

The FDA’s Innovation Initiative

Adam Clark, Ph.D., Director, Scientific and Federal Affairs, FasterCures

Earlier this month, the Food and Drug Administration (FDA) launched its “Innovation Initiative,” a new program intended to accelerate and reduce the cost of development and regulatory evaluation of innovative new medical devices submitted to the FDA.

This initiative seeks to advance efforts like the Defense Advanced Research Project Agency (DARPA)-funded project that created a brain-controlled prosthetic arm that restored near-natural hand activity through neural impulses. This was made possible by an innovative device, a microchip implanted on the brain. And FDA wants to see more of these ideas coming down the regulatory path.

Medical devices include everything from glucose tests and pacemakers to x-ray and laser equipment. As we turn to next generation devices that include nanotechnologies or novel imaging tools, we stand to improve early and accurate detection of disease and tailor treatment to each individual, a key element of 21st century personalized medicine. However, these technologies will also require special expertise to review and evaluate their ability to improve health.

Recent analyses in the past couple of months – notably AdvaMed’s assessment on medical device approvals, and PwC’s Medical Technology Innovation Scorecard – underscore the need for medical device review and approval processes to be up to par with the innovations that are coming down the pipeline. The hope is that through this initiative the FDA will be able to stay ahead of the curve and have the capacity needed to meet the new regulatory demands of novel medical and technological advances.

Often, innovation pushes the barriers of regulation by disrupting how a system works. This new proposal tries to strike the delicate balance of allowing FDA to fulfill its mission of ensuring new products are safe and effective, while encouraging revolutionary ideas to come to fruition.

As part of the initiative, the FDA proposes to establish a Center Science Council to prioritize projects to be considered. The agency would also like to establish third-party certification centers that could facilitate the review of new products to accelerate their submission to FDA. And proposes to build a Network of Experts – distinguished leaders in new technologies – to provide guidance to the FDA on scientific and technical issues related to a new product.

Earlier this year, President Obama declared his administration’s efforts to move towards a 21st century regulatory infrastructure. In order to do so, he emphasized that agencies like the FDA will need to pursue new models of review and regulation that take into account the state of our best science and technology and ensure these make it to the marketplace.

At FasterCures, we believe there’s great potential for the Innovation Initiative to fast-track truly effective and efficient medical devices so that they may be fully utilized by patients who need them most. It’s an alternative approach to the usual process and will be a program to track. We look forward to seeing this effort unfold.

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