FDA Failing the Public Over Medical Device Inspections

Thursday, September 11, 2008 by: David Gutierrez, staff writer
Tags: medical devices, health news, Natural News

(NaturalNews) The FDA does not inspect medical device manufacturing plants as frequently as safety or the law requires, investigators from the General Accountability Office (GAO) have reported to Congress.

"Americans depend on the FDA to ensure the safety and effectiveness of medical products, including medical devices, manufactured throughout the world," said GAO Health Care Director Marcia Crosse in her testimony to a House Energy and Commerce subcommittee. "However, our findings regarding inspections of medical device manufacturers indicate weaknesses,"

The law requires that within the United States, plants that manufacture high-risk medical devices such as pacemakers be inspected once every two years, but the FDA is inspecting such plants only once every three years. Manufacturing plants outside of the United States are inspected only once every six years.

The law does not specify how frequently the FDA should inspect foreign plants.

According the GAO report, the low inspection frequency arises from a critical lack of funding, which has also led to infrequent inspections of foreign drug manufacturing plants.

A recent report from the FDA's science board warned that underfunding is causing the agency to fall behind on monitoring new scientific advances and emerging threats, such as nanotechnology.

The FDA is responsible for regulating most food and cosmetics sold in the United States, in addition to all drugs and medical devices. Altogether, the products that the FDA regulates account for 25 percent of the money spent in the United States each year.

Other witnesses told the House subcommittee that the FDA needs more funding to solve its problems. Former FDA chief counsel told Congress that the FDA's $2 billion annual budget needs to be doubled by 2010.

FDA Commissioner Andrew von Eschenbach agreed that the agency needs more money, but said he prefers to identify "target areas" that need the funds, rather than just increasing the FDA's general budget.

"You don't just throw money [at the FDA]," von Eschenbach said. "It's as important to figure out how you're going to spend it."