Lawmakers debate efficiency of FDA
Few testifying at hearing agreed on how to improve medical device safety.

Minneapolis Star Tribune | Janet Moore | February 17, 2011

A hearing on Capitol Hill on Thursday provided little middle ground in the debate over whether medical devices are regulated too much, or too little, by the Food and Drug Administration.

The two-hour hearing of the House Energy & Commerce Committee's health subcommittee pitted concerns that unsafe products get on the market against arguments that the FDA's approval process stifles innovation.

Dr. Steven Nissen, a cardiologist with the Cleveland Clinic Foundation, called the current regulatory system for medical devices "antiquated." Nissen warned lawmakers against deregulating the system to a point that will put patients at risk.

But Ralph Hall, a law professor at the University of Minnesota, testified that the process is remarkably safe, based on his scrutiny of product recalls between 2005 and 2009. A little over half were due to "post-market" issues, mostly manufacturing problems, that wouldn't be detected by conducting more clinical trials before a device is approved, he said.

Six panelists testified, including Dr. Jeffrey Shuren, who heads the FDA's Center for Devices and Radiological Health. Since assuming his position a little over a year ago, Shuren has announced several initiatives designed to make the approval process more predictable and transparent for medical device companies.

Other changes in FDA regulations will likely result once the Institute of Medicine releases a report this summer on the way the vast number of devices are approved -- called the 510(k) process.

The issue has been closely followed in Minnesota, home to more than 300 medical technology companies including the world's largest, Fridley-based Medtronic Inc.

Meanwhile, Shuren said the agency needs more resources to better train employees and to stem turnover in its ranks.

"You can ask all you want, there's no more money," remarked Rep. John Shimkus, a Republican from Illinois.

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