FDA Official Defends Agency Against Lawmaker Criticism Over Device Approvals

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The Food and Drug Administration must walk a fine line between protecting innovation and ensuring medical devices are safe and effective, a top agency official told a House panel Feb. 17 in response to repeated criticisms from Republican lawmakers that the agency has become a hindrance to getting products on the market.

Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, told the House Energy and Commerce Health Subcommittee that the agency needs to give manufacturers clearer guidance regarding approval standards to keep the U.S. system competitive with Europe.

Energy and Commerce Committee Chairman Fred Upton (R-Mich.) said “device companies are being forced to market their devices first in Europe because the EU countries have predictable and consistent regulatory processes.”

Upton said the hearing on the impact of FDA device regulations on U.S. jobs “aims to fix” regulatory problems at FDA that “are hurting American innovation, costing American jobs, and hurting American patients.”

However, Shuren challenged the notion that FDA regulations are too onerous, saying that the agency's performance on reviewing device applications has been consistently strong. In testimony, Shuren said that 90 percent of all reviews of devices cleared through the 510(k) program--the method most devices reach the market--were completed in 90 days or less, and 98 percent of reviews were completed in 150 days or less.

Shuren also defended FDA from a report by Stanford University professor Josh Makower, which found that on average, agency reviews for 510(k) products take two years longer from the point of initial communication with the regulatory agency than reviews for similar products in Europe.

Makower, who testified at the hearing, said FDA has become more risk averse because it is afraid of making mistakes.

Lawmakers also asked Shuren about a study by PricewaterhouseCoopers, which found device recalls in Europe and the United States occur at about the same rate, even though the U.S. approval process takes significantly longer.

Industry trade group AdvaMed (Advanced Medical Technology Association) in a statement also noted “the growing lack of predictability and consistency in product reviews at the FDA, which needlessly delays patient access to safe and effective diagnostics and treatments.”

Shuren said there are “fundamental differences” between the U.S. and European systems, including different approval standards--for example, the EU lacks the requirement in U.S. law that a device be shown to be effective.

Industry's Role.

Speaking to reporters after the hearing, Shuren said he was “disappointed” to hear industry representatives tell lawmakers FDA is not doing its job.

Shuren said that while the agency has been meeting its goals for 510(k) reviews, the time between submission and clearance still has been increasing. One of the main reasons for that increase is problems with poor industry submissions, he said.

“They need to pull their weight,” Shuren said.

All too often, Shuren said, industry 510(k) submissions are missing key information, such as performance data, or even information about which predicate the device is being compared to. Since a 510(k) marketing clearance requires a device be “substantially equivalent” to one already legally marketed, missing predicate information throws off the entire clearance process, Shuren said.

“We're stepping up to the plate to do our part to get this right. But if it's going to work we need industry to do their part,” Shuren told lawmakers during the hearing.

Mark Deem, a partner in the device incubator the Foundry LLC, a group of device entrepreneurs and investors, said FDA is sometimes difficult to work with as it has been known to change the metrics and endpoints of clinical trials and ask for “impossible” information from manufacturers.

By Nathaniel Weixel


More information about the hearing is at http://energycommerce.house.gov/hearings/hearingdetail.aspx?NewsID=8221.