WASHINGTON - The medical technology industry praised introduction of a Senate bill that seeks to speed up the government's approval process for new devices, while consumer advocates called the proposal a shortcut that could harm patients.
The bill, co-sponsored by Minnesota Sen. Amy Klobuchar, would loosen rules that determine who can serve on advisory committees that review medical devices. The Food and Drug Administration's conflict-of-interest rules are stricter than those applied to the rest of the government, making it difficult to find people to serve, said Klobuchar, who introduced the legislation Thursday along with Sen. Michael Bennet, D-Colo., and Richard Burr, R-N.C.
The bill also would require the FDA to use "all reasonable mechanisms to reduce review times" when reviewing new products.
"We keep in place all key safety standards," Klobuchar said. "We deliberately didn't focus on changing the safety standards."
AdvaMed, a trade group representing medical devices manufacturers, including many in Minnesota, said the bill will help patients get access to life-saving technology.
"We are especially encouraged to see the legislation's focus on clarifying FDA data requirements, streamlining agency management processes, and its emphasis on the importance of attracting the best experts to FDA advisory committee," said AdvaMed's president and chief executive, Stephen Ubl, a Minnesota native.
Patient advocates, however, called the legislation's emphasis on speed a turn in the wrong direction. "This is clearly an attempt to weaken oversight in the approval process," said Michael Carome, director of health research for Public Citizen. "Innovation, if not adequately tested for safety, places the public at risk."
Klobuchar said her proposal has to do with inefficiency and won't affect the health and safety of patients.
"You might have one response from a consumer group," she said of critics. "But the patient groups for certain diseases who have been waiting years to get a change approved for a device that's already approved in Europe feel differently about this."
The debate over the way medical devices reach the market has heightened in the wake of a July report by the Institute of Medicine (IOM) that concluded that part of the FDA's approval process "lacks the legal basis to be a reliable premarket screen for the safety and effectiveness of moderate-risk devices."
Since the institute's report, the medical device industry has pushed aggressively for an approval process that gets devices to market without prior testing, so long as they are similar to products that have already been approved. The industry maintains that many delays are not related to safety, but the result of extraneous bureaucracy. The FDA has not adopted the IOM's suggestions to streamline or possibly replace the current approval process, choosing to seek more feedback from interested parties.
Klobuchar said the FDA approval process is so cumbersome that it has resulted in 40 percent decline in investment in the American medical device industry in the past three years. "A lot of the investment, especially on the small company front, has gone to Europe because their process has similar safety standards to ours, but it goes much quicker," the senator said.
Concern with the FDA approval process has attracted a lot of attention. President Obama has talked about streamlining the regulatory requirements. Meanwhile, legislation like Klobuchar's may soon grow in popularity. In fact, another Minnesotan on Capitol Hill, Republican Rep. Erik Paulsen, is fashioning his own bill for introduction soon, a spokesman said.
Jim Spencer • 202-408-2752