BB&T Washington Editor

A Jan. 29 report on FDA device inspections from the Government Accountability Office (GAO) has disclosed that the FDA is having a difficult time keeping up with inspections, continuing to turn up the heat on an agency with too many tasks and too few resources.

The GAO report, signed by Marcia Crosse, director of healthcare for GAO, was delivered to the Oversight and Investigations Committee of the House Energy and Commerce Committee, and Crosse’s testimony indicated that GAO is not optimistic about the third-party inspection initiatives now underway.

The report says that the agency typically inspects domestic Class III device makers only every three years, rather than every two years as required, and U.S. makers of Class II devices only every five years rather than every three years.

Foreign makers of Class II devices had seen an FDA investigator only every 27 years, on average, the report ssays, and overseas companies making Class III devices saw an FDA investigator only every six years.

GAO said that the third-party inspection program has been of limited value, with “the small number of inspections completed [raising] questions about the practicality and cost-effectiveness” of adding more third-party capacity.

GAO has addressed the third-party inspection program in previous reports to Congress. FDA was statutorily limited to contracting with 15 organizations to conduct inspections under the Accredited Persons Inspection Program (APIP). But while the limit was then raised, most of the companies that applied never got around to obtaining full certification from FDA to conduct the inspections.

The current GAO report notes that as of Jan. 11, FDA had accredited 16 such organizations. But of greater importance was the fact that “individuals from eight of these organizations had completed FDA’s training and had been cleared to conduct inspections.”

FDA and these inspectors had conducted 44 total joint training inspections, but “fewer manufacturers volunteered to host training inspections than have been needed.”

The report also says that FDA’s short scheduling for inspections have left third-party companies out “because they had prior commitments.”

The FDA Amendments Act of 2007, the report says, eliminated the requirement that FDA periodically inspect foreign device manufacturing plants, which may provide some relief to FDA’s inspection work plan.

FDA signed a cooperative agreement with Health Canada in 2006 for joint inspections of device makers by the two countries that would satisfy the requirements of both, but GAO expressed skepticism that the Pilot Multi-Purpose Audit Program (PMAP) audit agreement would make much difference, because it replicates the broader APIP program, designed in part to help firms cover the inspectional requirements of non-U.S. regulatory bodies.

The sheer volume of device manufacturing facilities that FDA is tasked with inspecting is impressive.

According to GAO, “more than 23,600 establishments that manufacture medical devices were registered as of September 2007,” with about half of them making Class II or Class III devices. The U.S. is home to roughly 5,600 of these; China accounts for another 675 and Germany 581.

Language barriers are a problem for FDA investigators. According to GAO, FDA has not been in a position to provide translators, relying instead on “an English-speaking representative of the foreign establishment being inspected, rather than an independent translator.”

FDA has relied largely on volunteers to handle the overseas inspections, but the agency indicated “it is difficult to recruit investigators to voluntarily travel to certain countries.” FDA field investigators must have three years of experience examining domestic plants before they can inspect overseas, a large limiting factor to the number available.

FDA also has not placed a particularly high priority on pre-approval inspections. GAO said that “relatively few” premarket inspections take place, in part because devices cleared under the 510(k) path do not trigger premarket inspections.

FDA’s information technology base also drew criticism from the GAO. Its legacy system for tracking device manufacturing plants, the Device Registration and Listing System, has a list of roughly 10,600 domestic and foreign plants, but it includes plants that are either not making medical devices at all or are not shipping the devices to the U.S.

The Operational and Administrative System for Import Support (OASIS) is “not intended to provide a count of establishments, but lists the source of imported devices. Apparently the U.S. Customs Service is responsible for some of the information in OASIS, and “inaccurate data entry by customs brokers at the border” produces duplication.

As a result, FDA employees must make comparisons between these two databases manually because “the databases cannot exchange information ... electronically.”