ParfumGigi@aol.com

30 janvier, 2008 14:23

Tuesday, January 29, 2008 8:51 PM

WASHINGTON -- The U.S. Food and Drug Administration fails to inspect domestic plants that produce pacemakers and other high-risk medical devices as often as required and checks few manufacturing sites overseas, congressional investigators told Congress on Tuesday.

The limited device inspections were a symptom of an overall lack of adequate funding that has stretched all parts of the agency, witnesses and lawmakers said at a hearing.

The FDA inspects U.S.-based makers of high-risk medical devices only once every three years, rather than every two years as the law requires, the Government Accountability Office estimated.

Comparable foreign manufacturing sites get inspected about every six years, the GAO estimated. There is no requirement for how often the FDA should inspect the overseas sites.

"Americans depend on FDA to ensure the safety and effectiveness of medical products, including medical devices, manufactured throughout the world. However, our findings regarding inspections of medical device manufacturers indicate weaknesses," Marcia Crosse, director of health care at the GAO, told a House Energy and Commerce subcommittee.

The findings were similar what the GAO found when it reviewed FDA visits to foreign drug plants, she added.

Device makers support "adequate" funding for the agency and will work to find ways the agency "can use its available resources as effectively and efficiently as possible," Stephen Ubl, president of industry group AdvaMed, said in a statement.

Other witnesses told lawmakers the FDA urgently needed a major boost in funding to handle increasing responsibilities. They pointed to a recent report, from a panel of the FDA's science board, concluding that lives were at risk because the agency is woefully behind in the latest scientific advances and is underfunded.

The FDA regulates medicines, medical devices, most foods, cosmetics and other products that account for about a quarter of every dollar spent in the United States.

"We are at the breaking point," said Gail Cassell, a vice president at Eli Lilly and Co and chair of the FDA science board panel that compiled the report.

Peter Barton Hutt, a former FDA chief counsel who consulted for the panel, called for a doubling of the FDA's roughly $2 billion budget within the next two years.

FDA Commissioner Andrew von Eschenbach said the agency had begun a major computer upgrade and was taking other steps to fix problems highlighted by the science board and others.

He declined to say how much FDA funding President George W. Bush's would request in a budget plan set for release next week. But von Eschenbach said he was identifying "targeted areas" for investment.

"You don't just throw money" at the agency, von Eschenbach told reporters after testifying at the hearing. "It's as important to figure out how you're going to spend it."