The U.S. Food & Drug Administration will open the public record on the 22-month $1.3 million study of its 510(k) program by the Institute of Medicine that called for the elimination of the program by which more than 4,000 medical devices are cleared for market.
The FDA said it is seeking public comment on the 200-plus page report, which contains several non-binding recommendations for the agency and its 510(k) premarket notification program.
“Many of the IOM findings parallel changes already underway at the FDA to improve how we regulate devices,” Dr. Jeffrey Shuren the director of the Center for Devices & Radiological Health, said in a prepared release. “These actions, plus a sufficiently funded device review program, will contribute to a stronger program. Any major modifications made to the agency’s premarket review programs should be based on sound science and through thoughtful and transparent discussion.”
On Friday, the IOM finally released its long-awaited report on the program, concluding that the 510(k) process fails to ensure that Class II medical devices are safe and effective before they hit the U.S. market. The agency should “gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices,” according to a press release.
Not surprisingly, the institute’s recommendations generated a swift repudiation from the medical device industry.
“The report’s conclusions do not deserve serious consideration from the Congress or the Administration,” said Stephen Ubl, president & CEO of the Advanced Medical Technology Assn., in prepared remarks. “It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven and unspecified new legal structure. This would be a disservice to patients and the public health.”
While some industry insiders say the report’s recommendations are dead on arrival, the FDA will proceed with plans to gather public input before making any final decisions on changes to the program.
In other FDA news, commissioner Margaret Hamburg defended her agency’s performance in a Wall Street Journal op-ed titled “America’s Innovation Agency: The FDA”
Hamburg wrote that while the agency does “bear some responsibility for the criticism” it receives from industry, it is “actively taking steps to improve the clarity, consistency and predictability of our regulatory systems. At the same time, we are working with the broader scientific community to address issues of scientific uncertainty that slow medical-product development and review,” she wrote.
“But misconceptions about our effectiveness as an agency could derail these efforts. One prevailing misconception is that the FDA lags behind Europe in approving medical products. The truth is that the FDA consistently approves the vast majority of priority drugs and medical devices as fast as, or faster than, our European counterparts. Of the 35 new cancer drugs approved either by the FDA or the European Medicines Agency (EMA) from October 2003 to December 2010, the FDA approved 32—in an average time per drug of 261 days. The EMA approved only 26 of these same 35 products, in an average time of 373 days. “
She also attacked what she called a “misconception that the FDA’s approval processes cost jobs and undermine U.S. global competitiveness.”
“The opposite is the case. By instilling confidence in American products and technologies, the FDA stimulates economic growth, creating jobs at home and opening markets overseas,” she wrote.
“Consider that the U.S. biopharmaceutical and medical-device sectors dominate their global industries. Even during the recent recession, from 2006 to 2009, the medical-device industry increased sales, boosted exports and expanded its work force. During the same period, major biopharmaceutical firms demonstrated strong financial performances. This could not have happened without widespread consumer confidence, at home and abroad.”
Her full piece can be read here.