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CLSA Wire

The Hill: Opinion: How is the FDA doing on medical device review times?

By Todd E. Gillenwater, op-ed exclusive to The Hill
Oct. 28, 2014

In 2012, following years of concern over U.S. Food and Drug Administration (FDA) medical device review processes that were viewed as increasingly unpredictable and inefficient, plaguing investment, innovation and U.S. competitiveness, stakeholders including Congress, the Agency and the medical device industry worked to identify potential solutions. The shared goal: to improve product review times while also maintaining rigorous scientific and patient safety standards.

The result was bipartisan passage and enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Included was reauthorization of the medical device user fee program, the Medical Device User Fee Amendments (MDUFA), in which medical device manufacturers agreed to pay significantly increased user fees in order to implement new policies requiring the FDA to improve the regulatory system’s clarity, consistency and predictability.

Have things gotten better? Has the medical device review process improved? Not surprisingly, the answer is not a simple yes or no. In many ways, it is still too early to tell. However, one dynamic is certain: leaders at the agency and, in particular, it’s Center for Devices and Radiological Health (CDRH) have worked to get processes, internally and with industry, back on track.

To evaluate trends in the device regulatory environment, we partnered with The Boston Consulting Group to produce “Taking the Pulse of Medical Device Regulation & Innovation,” a comprehensive report that seeks to communicate the real improvements we’ve seen at the FDA, while also constructively pointing to areas where there is still work to be done.

In the years since the passage and implementation of FDASIA, progress is evident in areas like the shortening of review times for Premarket Approval (PMA) products, the reduction in agency review backlogs and the narrowing of performance gaps across review divisions and branches. At the same time, 510(k) clearance times continue far above historic averages, the number of new devices submitted to the Agency for review is on the decline, and the 3-5 year device approval gap between Europe and the U.S. remains.

A strong, well-functioning FDA isn’t the only component necessary for continued medical technology investment and innovation, but it is a critical one.  The evidence to date illustrates what can be accomplished when Congress, the FDA and industry work together, but now is no time to pat ourselves on the back and move on.

Change can be hard and it can take time, especially when talking about an agency as large as the FDA. Success needs to be acknowledged and rewarded. Constructive attention, support and pressure applied to areas where improvements might not be coming along as quickly as expected. Additional new ideas discussed and deliberated.

Recent initiatives, such as the House Energy and Commerce Committee’s 21st Century Cures Initiative being led by Committee Chairman Fred Upton (R-Mich.) and Rep. Diana DeGette (D-Colo.) and joined by leadership at the FDA, show a commitment to this continued work.

We’re optimistic that when we publish updated data next year and beyond, it will show further and improved progress. And given what this is really all about – getting safe, new medical technologies to patients in need as quickly as possible – that is something we should all celebrate.

Todd E. Gillenwater is executive vice president of advocacy and external relations at California Life Sciences Association (CLSA), a nonprofit public policy organization representing leading academic institutions and biotechnology, medical device, diagnostics and pharmaceutical firms.

Read the op-ed at The Hill.