Yet Another 510(k) Hearing

Lawmakers on Capitol Hill continue to dig into the U.S. Food and Drug Administration’s (FDA) medical device review process—primarily the 510(k) program, the method by which the majority of medical technology is approved in the United States. This most recent inquiry was conducted by the Oversight and Government Reform Subcommittee in the House of Representatives on June 2. The volleys lobbed at the agency came from both Republicans and Democrats. The theme for the meeting was “Pathway to FDA Medical Device Approval: Is There a Better Way?”

Among the witnesses to appear before the committee were David Gollaher, Ph.D., president and CEO of the California Healthcare Institute (CHI); U.S. Rep. Erik Paulsen (R-Minn.); FDA Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren, M.D.; Rita Redberg, M.D., professor of medicine and director of women’s cardiovascular services in the division of cardiology at the University of California, San Francisco; and Jack Lasersohn, a general partner at The Vertical Group, a medical technology venture capital firm headquartered in Summit, N.J.

“The FDA and its regulatory policies profoundly influence the current state and future strength of the medtech industry,” said Gollaher. “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 American competitiveness.”

According to a recent CHI report, 510(k) clearances have slowed by 43 percent and approval times for more complex premarket approval (PMA) devices have lengthened by 75 percent. Complex medical devices approved via the PMA process at the FDA are approved in Europe on average nearly four years ahead of the United States, up from just over a year earlier in the millennium.

Those who addressed the committee discussed the importance of the medical device industry to the United States, focusing on improvements to patient care, job creation, and economic competitiveness.

In California, for example, the medical device industry employs 107,000 people, more than any other state in the nation. Approximately 1,300 medical technology companies are located in the Golden State, the majority with fewer than 50 employees.

“Today, Congress, the FDA, medical innovators, patient groups and other stakeholders can come together with the will and ideas to restore agency performance—to rejuvenate, support and sustain a strong, science-based FDA and efficient, consistent and predictable review processes to ensure safe and innovative technologies and devices for patients in need,” Gollaher said during his testimony. 

Paulsen said the FDA’s premarket review process lacks “consistency, predictability, and transparency,” which is making it difficult for medtech companies to release their products in the United States. One of the concerns that Paulsen cited is that reviewers often “shift endpoints” midway through the device review process. He said many companies report that FDA reviewers make new, seemingly arbitrary demands late in the product review process. Small companies, according to Paulsen, are hit the hardest by the problems with the FDA approval process.
“If this trend continues, more companies will look for greener pastures and take their innovations and their 400,000 high-paying jobs with them,” Paulsen said.

Paulsen cited Acorn Cardiovascular based in his home state of Minnesota as an example of the current “inconsistency” at CDRH.

According to Paulsen, Acorn Cardiovascular had several conversations with FDA staff about how to test its device. The company performed a randomized trial, met its targets, and, in the end, thought the device would be approved.

“But reviewers at the FDA moved the goalposts and required a new trial,” Paulsen accused. “Because of this, investors shied away [and] Acorn couldn’t raise the capital to perform another multi-million dollar trial and had to close its doors.”

In January, the FDA released new guidelines to update the 510(k) approval process. The plan contained 25 actions that the FDA intends to implement this year. A handful of those actions already have been put into practice, but most of them are scheduled to be implemented later this year. In addition to the 25 actions that already are being implemented, the FDA has identified seven more controversial recommendations that have not yet been resolved. Those recommendations are being reviewed by the Institute of Medicine (IOM), and the FDA expects to receive feedback from the IOM sometime this summer.

“FDA recognizes that it can do a better job at managing its premarket review programs,” Shuren countered during the hearing. “And we agree that, in many areas, insufficient clarity, consistency, and predictability on our part contributes to [medical device development] expenses. This is why we’ve undertaken a number of initiatives to improve our review processes.”

Paulsen, who also serves as the co-chairman of the bipartisan House Medical Technology Caucus, told lawmakers on Thursday that he’s working on legislation to simplify the approval process for medical devices.

“We’re throwing some ideas together right now to help streamline the [FDA],” Paulsen told reporters after testifying at the hearing, adding that he wants to ensure a more “predictable and transparent process.”

Paulsen said he hopes to have a bill ready within the next month and a half. He also has sponsored legislation to repeal a 2.3 percent excise tax on medical devices that would begin in 2013, but the two issues would be kept separate. The tax is expected to raise $2 billion a year to pay for the healthcare reform law.

Critics of the current state of U.S. device approval claim that Europe approves devices two years faster than the U.S. does, and warn—as Paulsen did in his testimony—of a pending exodus of cutting-edge medical device companies that currently employ 400,000 workers at 8,000 U.S. firms.

The U.S. medical device sector’s supremacy is threatened not by “cheap overseas labor or countries with more competitive tax structures, but by the bureaucracy within our own borders,” Paulsen testified.

Following questions from Republican lawmakers regarding the European approval process and its perceived efficiency compared with the United States, Shuren said the recent recession created a more “risk-averse” investment environment that helped push medical device companies to launch in Europe, rather than its relatively easier path to market clearance.

“Over the past decade, most indicators of the medical device industry’s success have gone upward,” Shuren said. “However, the recession has changed the business model to be more risk adverse and more sensitive to changes at the FDA.”

The CDRH director said he was “astonished” that there have been calls for the FDA to lower its standards in order to compete with the European Union’s approval process. “It’s not in our best interest,” he added.