Jared A. Favole, Wall Street Journal: February 18, 2010
GAITHERSBURG, Md. (Dow Jones)–U.S. Food and Drug Administration officials Thursday told industry experts and the public that it lacks certain powers over the medical-device industry and may go to Congress to ask for more authority.
FDA officials who oversee the agency’s medical-device approval system said the regulatory body has limited powers to recall devices that are already on the market and can’t adequately oversee how device makers label their products. They said the agency also has limited power over products once they are on the market.
The FDA comments came as part of a meeting where government officials and mostly industry representatives from companies such as Medtronic Inc. (MDT) discussed ways to possibly alter and strengthen its medical-device approval process. The focus was on an FDA approval system for moderate-risk devices such as orthopedic knee and hip replacements. The agency has said that this system is open to abuse and wants to revamp it. The approval process, called 510k, is used when a company wants to sell a new device that is based on a product already on the market. The FDA’s main process for approving high-risk medical devices such as heart implants isn’t under an intense review.
Device-manufacturer representatives said they feared changes to the 510k system would dry up investment in the industry and keep novel devices away from patients. They said they worry the FDA is erecting hurdles that are too high to clear.
“There is fear in the industry that the FDA may be moving in a direction that isn’t rational,” Jon Kahan, director of the medical device practice at the Washington law firm Hogan & Hartson. Others who work in the industry also cautioned the FDA from changing the entire process, saying they haven’t seen anything beyond anecdotal reports to suggest there are major problems with the 510k program.
Dr. Jeff Shuren, head of the FDA’s device division, said concerns about the 510k program have been around for several years. So the best thing the agency can do is “look under the hood…and see what the root causes are,” he said.
The FDA officials aired concerns about several problem areas in the system, including that the FDA often doesn’t know when one company has sold the ownership of a medical device to another company. “You can imagine how hard it is to investigate” problems and take enforcement actions when the FDA doesn’t know who owns the device, said Heather Rosecrans, who runs the 510k program at the agency.
In one example, Rosecrans said one unidentified company bought the rights to more than a dozen different medical devices from another manufacturer. In reviewing the product information that the original owner had submitted prior to receiving FDA approval, the purchasing company found that “all of it was fraudulent” and subsequently told the FDA about it. Rosecrans said the FDA then was able to pull those products from the market because they had been approved based on false information.
FDA officials and industry representatives also highlighted the success of the 510k process, saying it has fostered innovation and helped make the U.S. a leader in device technology.
Dr. Diana Zuckerman, president of the National Research Center for Women & Families, a Washington-based patient advocacy group, offered one of the few non-industry perspectives at the meeting. She said more information and testing is needed for many of the devices approved through the 510k system.
Many industry representatives and even a few FDA officials said devices that go through the 510k program do include a lot of information. Still, Shuren said only about 8% to 10% include the clinical data that are generally required for high-risk devices approved through the FDA’s other major device-approval system.
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207; jared.favole@dowjones.com