FDA's effectiveness in conducting device manufacturing inspections overseas was criticized by the Government Accountability Office in testimony before Congress that found overall "weaknesses" in the agency's inspection of medical device manufacturers.

In Jan. 29 ¹ testimony before the House Energy and Commerce Committee's Oversight and Investigations Subcommittee, GAO Health Care Director Marcia G. Crosse reported that FDA conducts "relatively few" foreign manufacturing inspections for higher-risk devices, such as pacemakers. In addition, foreign device sites "pose unique challenges to FDA in human resources and logistics," Crosse noted.

According to GAO, FDA officials estimate that overseas facilities are inspected every six years for high-risk devices and every 27 years for medium-risk devices, such as hearing aids.

The hearing was convened in response to growing concerns in Congress that FDA lacks the resources and technology needed to regulate devices, drugs, food and other products. It also addressed a Nov. 29 FDA Science Board report that found that FDA needs more money and manpower to effectively regulate emerging technologies, such as wireless devices, nanotechnology and robotics (² Also see "FDA Scientific Capacity Inadequate; New Device Technology At Risk" - Medtech Insight, 10 December, 2007., p. 5).

The GAO investigation was requested by Democratic committee leaders after a November hearing in which GAO reported "significant weaknesses" in FDA regulation of foreign drug manufacturers.

Committee chair John D. Dingell, D-Mich., and subcommittee chair Bart Stupak, D-Mich., asked the office to assess FDA's conduct of foreign device manufacturing inspections and the potential value of relying on third-party organizations to increase foreign facility oversight (³ Also see "House Panel Probes FDA Inspections Of Overseas Device Facilities" - Medtech Insight, 17 December, 2007., p. 8).

GAO investigators found that FDA inspectors face myriad challenges overseas, including language barriers, difficulty recruiting investigators to travel to certain countries and trouble extending trips if problems are found during inspections, Crosse said.

She also pointed out FDA's lack of a dedicated staff of foreign facility inspectors. Inaccurate estimates of the number of foreign sites that need to be inspected also contribute to the challenge of managing overseas inspections, GAO noted.

From fiscal year 2002 through fiscal 2007, FDA conducted about 1,494 U.S. and 247 foreign inspections per year, she noted. In other words, each year FDA inspected about 27% of the registered U.S. manufacturing sites for class II and III devices; and 5% of foreign manufacturing sites for these devices.

Among the most commonly inspected foreign countries, China had the lowest inspection rate, GAO emphasized.

FDA recently said it is considering establishing posts in foreign countries, starting with China, to perform inspections and foster relationships with foreign government counterparts and industry (⁴ Also see "FDA Aims To Establish Overseas Staff Posts, Starting In China" - Medtech Insight, 14 January, 2008., p. 3).

"They don't have the same authority to demand entry at a facility overseas as they have in the United States, but they do have the ability to stop those products from being imported if they don't cooperate," Crosse said. "I think it's a very positive thing that they are trying establishing a presence overseas."

U.S. Facility Inspections Also Backlogged

In addition, GAO criticized FDA for failing to inspect high- and medium-risk domestic device manufacturing facilities every two years, a timetable required by law. Crosse testified that FDA inspects U.S. manufacturing facilities about once every three years for Class III devices and every five years for Class II products.

CDRH's Office of Compliance has repeatedly cited limited resources as a barrier to achieving the two-year inspection requirement. Instead, it has implemented a risk-based assessment plan to prioritize inspections for the highest-risk devices.

- Jessica Bylander (j.bylander@elsevier.com)

FDA Inspections Of Foreign Device Manufacturers Anemic – GAO Testimony

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