The Government Accountability Office (GAO) recently told Congress that the U.S. Food and Drug Administration (FDA) inspects an estimated seven percent of foreign drug manufacturing facilities. GAO can only provide an estimate because FDA doesn't know how many foreign facilities are subject to inspection due to inaccurate and uncoordinated databases that have vastly different estimates of the number of drug makers subject to the foreign drug inspection program. At this inspection rate, it would take FDA more than 13 years to inspect all existing facilities one time, assuming no additional facilities were added to the list.

FDA has the responsibility to safeguard the supply and effectiveness of drugs sold in the U.S. and requires both domestic and foreign drug makers to register with the agency. FDA is required to inspect domestic manufacturers every two years, but there is no requirement for inspecting foreign manufacturers. According to GAO, FDA inspections varied from 190 to 295 foreign establishments annually between Fiscal Years 2002 and 2007.

GAO's health care director, Marcia Crosse, testified Nov. 1 at the House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations hearing on the FDA's foreign drug inspection program. According to her testimony, GAO told Congress in 1998 that FDA's foreign drug inspection program had serious flaws in the management of its inspection data and that "it lacked a comprehensive automated system for tracking this important information."

The databases FDA currently uses for the inspection program, Crosse reported, were not designed for this kind of data tracking. As a result, one database reports that about 3,000 drug manufacturers were registered to sell drugs in the U.S. in FY 2007, while another indicates that drugs from more than 6,800 foreign manufacturers were imported that year.

Furthermore, according to the testimony, the foreign inspection program faces a unique set of problems: "FDA does not have a dedicated staff to conduct foreign inspections and relies on those inspecting domestic establishments to volunteer." FDA inspectors do not arrive at the foreign facilities unannounced, and they have to rely on English-speaking employees at the facilities because FDA does not generally provide translators.

Other witnesses at the hearing described how the system of inspecting U.S. manufacturers and of approving drugs — those manufactured domestically — remains "the gold standard" to which other countries aspire; however, the number of drugs and drug ingredients imported is increasing rapidly while FDA's capacities decline. For example, in his written testimony, William K. Hubbard, a former FDA associate commissioner in the drug program, described this dismal picture:

 

• FDA's inspection rate for imported drugs (and drugs ingredients) when they arrive at a U.S. port is around 1%, which means that the vast majority of imported drugs do not receive an FDA inspection upon entry into this country.
• The chances of an imported drug being sampled and tested at entry to this country is even lower; in fact, of the millions of drug shipments arriving from foreign countries last year, only 340 samples were taken for laboratory testing.
• Although there are approximately 3,000 foreign drug manufacturers registered with the FDA, only 341 were inspected last year. And even that number is misleading, as most of those inspections were so-called "preapproval inspections" for drugs about to be approved by FDA for marketing. The number of good manufacturing compliance inspections was perhaps two dozen or so.

Hubbard and other witnesses called for increased staff, more resources to fix FDA's poor information systems, and improved inspection approaches.

Andrew C. von Eschenbach, Commissioner of FDA, acknowledged the challenges the agency faces in the growing global market for drugs. Specifically, he reported that upgrading FDA's information systems is one of his top priorities and outlined the many efforts underway at FDA to improve those systems.

In addition, he outlined several cooperative arrangements with international organizations to share information and improve inspection systems globally. As other federal officials have done in recent congressional testimony, von Eschenbach referred to President Bush's Interagency Working Group on Import Safety (IWG) as the entity charged with developing a system to ensure the safety of imported goods. As OMB Watch recently reported, these officials have used the work of the IWG to deflect congressional criticism of federal agencies' poor performance on import safety issues and to delay action until the release of the IWG report expected later in November.

GAO's Crosse summed up the urgency of the problem, however, in her concluding observations on the similarities between the current situation and GAO's description nine years ago when she wrote, "[U]ntil FDA responds to systemic weaknesses in the management of this important program, it cannot provide the needed assurance that the drug supply reaching our citizens is appropriately scrutinized, and safe."