UPDATE:
The House Energy & Commerce Committee's subcommittee on Health reconvened later this morning and listened to testimony from a six-member panel regarding the FDA approval process for medical devices. The hearing lasted for close to two hours. Here are a few takeaways:

Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health: Shuren challenged the view that the European device approval process for medical devices is more efficient than our own and said it's difficult to compare the U.S. and European systems. While admitting the FDA can do a better job at improving the efficiency, predictability and transparency of the device approval process, he said more funds are needed for staff training and to stem turnover. In addition, medical device companies occasionally submit flawed data to the agency, which hampers the approval process. He also noted that the recession may have something to do with fewer venture capital dollars flowing into med-tech start-ups.

Dr. Josh Makower, professor of Medicine at Stanford University; CEO, ExploraMed Development LLC; Venture Partner, New Enterprise Associates: Makower said investment money for med-tech start-ups is drying up because the FDA has grown too risk averse. On average, it takes $94 million to fund a new company developing a high-risk device, $75 million of which is spent getting FDA approval. The $20 billion med-tech tax on annual revenue to pay for health care reform is especially hard on small start-ups, which may not report any profits in the early years. "It's absolutely imperative for small companies to modify that tax proposal," he said. Start-ups need to be making $70 million to $100 million in revenue "before making one dollar of profit."

Mark Deem, Managing Partner and Chief Technology Partner of the business incubator, The Foundry: Gave several examples of med-tech companies that shut down rather than wrangle with the FDA. He cited difficulties with getting the FDA's go-ahead to even start a clinical trial of the medical device as a factor, too.

Dr. Rita Redberg, the director of Women's Cardiovascular Services at the University of California San Francisco Medical Center, and author of a recent editorial in the Archives of Internal Medicine that is critical of the way the FDA approves medical devices: The controversial 510(k) approval process for medical devices was "well-intentioned" when enacted in 1976, but since then devices have grown increasingly complex, and regulation hasn't kept up to make sure they're safe and effective. "A device can't be innovative unless it shows a benefit to patients," she said. FDA's electronic databases are lacking, and the agency needs more resources from Congress to improve.

Dr. Steven Nissen, a professor of Medicine at Case Western Reserve University and chair, Department of Cardiovascular Medicine, Cleveland Clinic Foundation: Nissen called the regulatory system for medical devices "antiquated." He noted manufacturing facilities making medical devices approved through the less-stringent 510(k) pathway aren't inspected by the FDA. Warned lawmakers against deregulating a system to the point "that will put patients at risk."


Ralph Hall, law professor, University of Minnesota: Said his recent study on medical device recalls found that more than half the problems with products occur once they are on the market. Additional pre-market studies won't change that, he said. He says, based on his analysis of product recalls, the 510(k) approval process has an excellent safety record. "Can we do better? Of course."

Janet Moore covers medical technology for the Star Tribune.

At a hearing in Washington, D.C. this morning, seven members of Congress offered their views about how medical devices are approved by the Food and Drug Administration (FDA).
Is that regulatory framework a job-killing, inefficient process that stymies innovation? Or is it too lax to protect patients from ineffective and potentially unsafe medical devices?
The real debate before the hearing of the House Energy & Commerce Committee's subcommittee on Health didn't quite gain traction because members had to depart after about 20 minutes for a vote on the House floor.The hearing is expected to resume later this morning.
But several members briefly expressed fears that the current FDA approval process for new devices is so clunky, it is threatening U.S. competitiveness. If patients want the best medical technology, they will likely find it in Europe, said Rep. Joseph Pitts, a Republican from Pennsylvania. Pitts and several other lawmakers claimed it takes two years longer to approve a new medical device in the United States than in Europe.
But Rep. Henry Waxman, a Democrat from California, said "we cannot talk about innovation without talking about the safety and effectiveness" of medical devices. Waxman said he's heard "countless and often tragic" stories of patients being harmed by medical devices that did not go through a rigorous vetting before being launched in the United States.
Scheduled to testify today before the committee are: Dr. Jeffrey Shuren, director of the FDA's device division; Dr. Josh Makower, a venture capitalist and Stanford University professor; Mark Deem, head of The Foundry; Ralph Hall, a law professor at the University of Minnesota; Dr. Rita Redberg, of the University of California-San Francisco; and Dr. Steven Nissen, of the Cleveland Clinic Foundation.

Janet Moore covers medical technology for the Star Tribune.