FDA Criticized Over Device Approvals

WASHINGTON – Congressional Republicans criticized the Food and Drug Administration on Thursday over medical-device approvals, saying the clearance process has become so slow and unreliable that device makers are moving to Europe and taking jobs with them.

An FDA official challenged those assertions during a House hearing and said the European system lacks safety checks. He was joined by two prominent doctors who said that in the wake of recent device recalls, including some linked to serious injuries and deaths, the FDA must review its use of a short-cut clearance program. The program is popular with industry, which doesn't want it restricted.

The hearing on the impact of FDA device regulations on U.S. jobs was held at the health subcommittee of the Energy and Commerce Committee.

The Energy and Commerce chairman, Fred Upton (R., Mich.), criticized the regulatory process. "Device companies are being forced to market their devices first in Europe," he said. "This hearing aims to fix that."

Republican lawmakers including Leonard Lance of New Jersey, home to many device makers, stressed the role of medical-device manufacturers in the U.S. economy, saying that delays in product approvals threaten U.S. pre-eminence in the industry.

In testimony, Jeffrey Shuren, director of the FDA device division, acknowledged the economic importance of the industry, noting that it is the fourth-largest sector for venture-capital investment, up from 13th a decade ago. He agreed with the legislators and industry witnesses that the FDA needs to give manufacturers clearer guidance regarding approval standards to keep the U.S. system competitive.

But Dr. Shuren criticized the faster European review system and suggested that if the U.S. adopted it, lawmakers would end up holding hearings about patients who got hurt.

"There is significant underreporting of safety problems in some European countries, and it takes longer to identify safety problems in Europe," he said.

He described a surgical sealant and a breast implant that didn't have FDA approval but were used in thousands of patients in Europe. The products were then pulled from the market over safety issues, he said.
Dr. Shuren also said in written testimony that device makers in Europe can "forum shop" their products to outside reviewers who are subject to minimal oversight.

Three witnesses who have worked with the industry testified that the longer approval time in the U.S. compared to Europe has had a negative impact on entrepreneurial jobs and on new investments in U.S. medical device start-ups.

Josh Makower, a venture capital investor in California who has studied the economics of the device industry for years, said, "The FDA has become more risk-averse" because it fears making mistakes. Dr. Makower, a consulting medical professor at Stanford University, said it takes about two fewer years to review innovative medical devices in Europe.

Dr. Shuren said that the FDA is improving its review times, but that "industry isn't pulling its fair share," and sometimes does "poor clinical studies" that delay approvals.

Mark Deem of the Foundry LLC, a group of device entrepreneurs and investors in California, said the FDA sometimes makes "impossible" demands for "extraordinary" data from companies, which has cost the U.S. jobs.

Republican Rep. Mike Burgess of Texas, a physician, said afterward in an interview that the FDA and device industry have a big failure to communicate. "Dr. Shuren keeps saying they don't come to the FDA to talk about what they are doing, and the makers say the FDA is changing the game all the time," Rep. Burgess said.

Cardiologist Steven Nissen of the Cleveland Clinic testified about a study he co-authored, which was published this week. It showed most device recalls involving serious or life-threatening hazards in recent years had been cleared by the FDA through its abbreviated 510(k) program, and were not tested in patients.

The device industry's main trade group, the Advanced Medical Technology Association or AdvaMed, said more than 99 percent of devices cleared in the 510(k) program haven't been recalled, and warned that slowing down the program could harm patients.

The device industry has pursued an aggressive strategy on Capitol Hill since the midterm elections to protect itself from new restrictions. The industry is pushing to undo a 2.3 percent fee on medical devices that was imposed as part of the health-care overhaul and could cost makers $20 billion over the next decade.

In January, AdvaMed wrote the new chairman of the House oversight committee, Darrell Issa (R., Calif.), expressing concern over pending changes in FDA approval guidelines. The group said American jobs and economic growth need "a consistent, predictable process," at the FDA.

The top lobbyist at AdvaMed recently left the group to become policy director for House Speaker John Boehner (R., Ohio).