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House Committee Hears Criticisms of FDA Devices Review Process

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The House of Representatives committee that serves as a government watchdog held a hearing yesterday focused on whether an overstretched Food and Drug Administration is slowing down the advance of new medical devices, hurting the growth of industry, and making venture investors skittish about backing medical device start-ups.

The House Committee on Oversight and Government Reform's Subcommittee on Healthcare heard testimony from representatives from the FDA, the biomedical industry and research institutes, the venture capital community, and a House member, about how the regulatory process for devices may be a drag on the development of new technologies.

"The FDA and its regulatory policies profoundly influence the current state and future strength of the medtech industry," David Gollaher, president and CEO of the medical technology advocacy group the California HealthCare Institute, said in a prepared statement. "But its regulatory processes have become unpredictable and slow, which, when combined with the impact of the Great Recession, the capital markets crisis, and more efficient regulatory processes in Europe, are having enormous and far-reaching effects on the American competitiveness."

Gollaher said that according to a CHI report 510(k) clearances for devices have slowed down by 43 percent and approval times for complex devices have lengthened by 75 percent over the last few years. In addition, he noted that complex medical devices approved through the pre-market approval process are approved in Europe on average nearly four years ahead of the US.

Jack Lasersohn of The Vertical Group, a medtech venture capital fund, told the committee that although "revolutionary research is ongoing, fewer groundbreaking medical devices are making it to the marketplace, and those that do make it are taking longer and costing significantly more to get there. As a result, investment in medical devices is beginning to dwindle.

"Worse, a growing body of research suggests that the performance of the FDA has played a direct role in this decline. For most entrepreneurs and investors, the process has grown unpredictable – if not inscrutable," Lasersohn stated.

He also said that companies have recently found that it takes two years longer to navigate the FDA's approval process for low- and moderate-risk devices than it does in Europe, and that for high-risk devices the US process took five times longer than it did in Europe, according to a recent report from Stanford University.

FDA's Jeff Shuren, who is Director of the Center for Devices and Radiological Health, said the agency "recognizes that it can do a better job at managing its premarket review programs," but he disputed the accuracy of the picture presented by CHI.

He said that under the 510(k) program, which is used for 90 percent of the devices examined each year, "90 percent of our reviews were completed in 90 days or less, and 98 percent of reviews were completed in 150 days or less, as we committed to do under" the Medical Device User Fees Amendments of 2007 Act.

He cited a report from PricewaterhouseCoopers from earlier this year which stated that success in the US medical technology industry is in part due to FDA's leadership, which has implemented standards and guidelines to ensure safety and efficacy that have instilled confidence in the industry's products worldwide and led other countries to emulate FDA's approach.

Shuren said most of FDA's process problems have come from "increasing workload, turnover of key staff, growing device complexity, and poor-quality submissions by industry that require significant time and attention to address. He also said that premarket approval for breakthrough devices increased by 56 percent over the past two years, and that more of these are representing more complex devices.

Lasersohn agreed with Shuren and Gollaher on some of the causes for these problems, such as high employee turnover at FDA, but he also said that the US has been leaning toward a culture where risk-benefit analysis can squelch new innovations.

"Today, the FDA, the press, Congress, consumer groups and others overwhelmingly focus on "direct" risks: product side effects, adverse events and technical product failures. Just as important to consider are indirect risks – distortions in the regulatory process, for example," Lasersohn said.

Shuren said that FDA is listening such advice.

"We know that medical device development is expensive. And we agree that, in many areas, insufficient clarity, consistency, and predictability on our part contributes to those expenses," he said, explaining that FDA has undertaken a review process that began in 2009 that has already led to some steps being taken at the agency.

Shuren also said that FDA's new initiatives to address its problems include streamlining review for lower-risk products, publishing a guidance for clarifying when clinical data is necessary, developing a network of external experts to advise on scientific issues, and establishing a new Center Science Council to ensure more timely and consistent science-based decision making. The agency also is establishing a voluntary, third-party certification program for US medical device test centers, issuing a guidance on using clinical studies conducted outside the US, and engaging in public-private partnerships to advance regulatory science.

Gollaher presented several central recommendations that CHI has developed for FDA to address many of these issues and concerns, some of which FDA may already be addressing: FDA should focus on core principles and its primary mission, such as safety and efficacy, and not expand to create new authorities and responsibilities; Congress should make "a steady and sustained commitment" to funding FDA and not cut its budget, even in a difficult fiscal environment; FDA should undertake and support more efforts to train agency reviewers and managers; Europe's device review model should be studied for how it may inform the US model; FDA and industry should be encouraged to collaborate more; and there should be a more balanced approach to calculating benefit and risk for medical devices.

Lasersohn added that as the global economy becomes more connected American medical device makers will face stiffening competition from abroad "for capital, for markets, for talent, and for jobs."

"As these competitive forces gather momentum, investors, managers and policymakers ignore them at their peril," he said. "If FDA regulation is just one factor among several, it nonetheless can be pivotal."

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