“We’re still concerned that the agency’s oversight of medical products remains on the GAO’s high-risk list more than two years now after earning that infamous designation, and that’s not acceptable,” Sen. Herb Kohl (D-Wis.), the committee’s chairman, said during the hearing.
High-risk medical devices, considered class III by the FDA, must go through the pre-market approval process, which is more stringent because it requires clinical data, according to the GAO report. A new high-risk device can be approved through the faster 510(k) process, however, if it was approved before 1976 and is “substantially equivalent” to one already on the market.
Testimony at the hearing addressed not just the FDA’s approval rates for medical devices, but also looked at the agency’s handling of recalls, pre-market review and post-market surveillance.
The DePuy ASR hip implants, which are considered a high-risk medical device, were approved under the 510(k) process and were recalled in August. A patient who had received one of the recalled hip implants provided testimony at the Senate hearing. The panel also included Diana Zuckerman, president of the National Research Center for Women & Families. She is the author of a recent study that found most recalled high-risk devices were approved through the 510(k) process (Feb. 21, p. 16).
Dr. William Maisel, chief scientist for FDA’s Center for Devices and Radiological Health, told the Senate committee last week that the agency identified improvement areas after conducting an 18-month review. He cited the need to strengthen the agency’s “consistency and transparency in decisionmaking,” as well as its science-based decisionmaking.
Industry groups, however, criticized the FDA from a different angle: They said the agency is holding back innovation. David Nexon, senior executive vice president of the Advanced Medical Technology Association, called the FDA’s performance “a key factor in our loss of competitiveness.”
California Healthcare Institute President and CEO David Gollaher called the FDA’s regulation of medical devices “increasingly slow and unpredictable,” according to testimony he prepared for a similar hearing postponed last week by the House Oversight and Government Reform Health Care Subcommittee.
The La Jolla-based public policy organization, which represents a number of players in California’s medical technology industry, said it supports some of the recent FDA efforts, such as the agency’s new priority review program for “breakthrough” medical devices. “The proof is going to be in the data and seeing whether we see a real improvement in our review times and approval times” for pre-market approval and 510(k) devices, Gollaher said in an interview. “It’s too early to tell whether the changes the FDA is making right now are going to have a material effect.”
Gollaher also said the CHI is concerned with the rising number of companies—especially those backed by venture capital—that choose to launch new medical technologies abroad rather than wait for the FDA to approve them in the U.S. first. “Complex” medical devices facing the pre-market approval process in the U.S. will get approved, on average, four years earlier in Europe, according to a report released by the institute and the Boston Consulting Group in February.
“The trend seems to be accelerating,” Gollaher said. “And it’s a cause for concern because when all that activity happens offshore, the U.S. loses the jobs and the innovation that goes with that.”