Medical Treatment, Out of Reach
Late last year, Biosensors International, a medical device company, shut down its operation in Southern California, which had once housed 90 people, including the company’s top executives and researchers.
The reason, executives say, was that it would take too long to get its new cardiac stent approved by the Food and Drug Administration.
“It’s available all over the world, including Mexico and Canada, but not in the United States,” said the chief executive, Jeffrey B. Jump, an American who runs the company from Switzerland. “We decided, let’s spend our money in China, Brazil, India, Europe.”
Medical device industry executives and investors are complaining vociferously these days that the industry’s competitive edge in the United States and overseas is being jeopardized by a heightened regulatory scrutiny.
The F.D.A., they and others say, appears to be reacting to criticism that its approvals for some products had been lax, leading to a spate of recalls of some unsafe medical devices, like implanted defibrillators and hip replacements.
Now, executives of device companies say the F.D.A. has gone too far in flexing its regulatory muscle, and they worry that a slower, tougher approval process in a weakened economy could chill investments and cripple innovation.
In addition, they say that American patients are being deprived of the latest technology because companies routinely seek approval for new devices in Europe first. For instance, heart valves that can be installed through a catheter instead of open-heart surgery have been available in Europe since 2007 but will not be available in the United States until late this year at the earliest.
“Ten years from now, we’ll all get on planes and fly somewhere to get treated,” said Jonathan MacQuitty, a Silicon Valley venture capitalist with Abingworth Management.
Marti Conger, a business consultant in Benicia, Calif., already has. She went to England in October 2009 to get an implant of a new artificial disk for her spine developed by Spinal Kinetics of Sunnyvale, Calif.
“Sunnyvale is 40 miles south of my house,” said Ms. Conger, who has become an advocate for faster device approvals in the United States. “I had to go to England to get my surgery.”
Stenum Spine Hospital in Germany has performed disk surgery on 1,000 Americans over the last eight years, said Jim Rider, the hospital’s American marketing agent.
Acknowledging industry concerns, the F.D.A. on Tuesday proposed creating an “innovation pathway” aimed at speeding regulatory reviews of a small number of groundbreaking devices. And last month the agency announced measures it said would make the regulatory process more predictable for the vast majority of devices.
“A consistent and predictable review process will stimulate investment here at home and keep jobs from going overseas,” Dr. Jeffery Shuren, the director of the agency’s medical device division, told reporters.
But Dr. Shuren said the F.D.A. would not relax its standards, arguing that Europe’s system might be too lax. He said that a breast implant, a lung sealant and an implant for elbow fractures were approved in Europe but not in the United States, and then had to be taken off the market in Europe for safety reasons.
“We don’t use our people as guinea pigs in the U.S.,” he said
Medical device executives said they welcomed the steps, but continued to express concerns. Consumer advocates, like Dr. Sidney Wolfe of Public Citizen, however, said that device regulation was already much less stringent than for drugs and that the F.D.A. was caving in to industry demands rather than ensuring consumer safety.
Dr. Charles Rosen, a spine surgeon who is also president of the Association for Medical Ethics, said that the newest devices were not always best. He said he had at least 50 patients who had suffered serious problems from an older artificial disk. Many of those patients, he said, had gone to Europe to get them before they were available in the United States.
Just since November, three reports — two sponsored by device industry trade groups and one conducted by the consulting firm PricewaterhouseCoopers — have raised concerns about the F.D.A. approval process. One report found that the rate of recalls in Europe was similar to that in the United States, suggesting faster approvals overseas were not hurting patients.