GAO Criticizes FDA’s Foreign-Drug Inspection Process

November 16, 2007
Patricia Van Arnum
ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Government Accountability Office issued findings that are largely critical of the US Food and Drug Administration in managing its inspections of foreign drug-manufacturing facilities.

Washington, DC (Nov.1)-The US Government Accountability Office (GAO) issued findings that are largely critical of the US Food and Drug Administration in managing its inspections of foreign drug-manufacturing facilities.

“FDA’s effectiveness in managing the foreign drug inspection program continues to be hindered by weaknesses in its databases,” said Marcia Crosse, GAO’s director of health care, in prepared testimony. “FDA does not know how many foreign establishments are subject to inspection. Instead, FDA relies on databases that were not designed for this purpose. Further, these databases contain inaccuracies that FDA cannot easily reconcile.”

Crosse testified before the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigation earlier this month. The subcommittee held a hearing about FDA’s foreign-inspection process that was intended to evaluate the agency’s effectiveness in overseeing foreign inspections and the agency’s resource allocation for this function. See story in the Nov. 8, 2007, ePTCongress Focuses on FDA Inspections of Foreign Drug Facilities

GAO reported nine years ago that FDA needed to improve its foreign drug inspection program (GAO/HEHS-98-21). “Questions remain as to whether FDA has improved its management of the foreign drug inspection program,” concluded the recent GAO analysis.

The relatively small number of foreign inspections by FDA was cited as a major concern by the GAO analysis. Using a list of 3249 foreign facilities that FDA had prioritized for inspection, the GAO found that FDA may inspect about 7% of foreign establishments per year. Of these 3249 foreign facilities, there were 2133 foreign facilities for which FDA could not identify a previous inspection. Of the remaining 1116 foreign facilities on FDA’s priority list, 242 had received at least one inspection, but had not received a good-manufacturing-practices (GMP) surveillance inspection since fiscal year 2000.

GAO found that most of FDA’s inspections of foreign facilities are conducted as part of the preapproval process (i.e., when processing a new drug application or an abbreviated new drug application), rather than as GMP surveillance inspections, which are used to monitor the quality of marketed drugs. “Although FDA used a risk-based process to develop a prioritized list of foreign establishments for GMP surveillance inspections in fiscal year 2007, few such inspections are completed in a given year,” specified Crosse in written testimony. Based on FDA information to the GAO, approximately 30 such inspections were completed in fiscal year 2007 and at least 50 are targeted for inspection in fiscal year 2008.  

GAO provided additional data to illustrate the disparity in the number and type of inspections (preapproval or GMP survelliance) between domestic and foreign drug-manufacturing facilities. From fiscal year 2002 through fiscal year 2007, FDA conducted 1445 foreign inspections: 1177 of these inspections included a GMP component, of which 998 were conducted in conjunction with a preapproval inspection. In contrast, FDA conducted 9694 inspections of domestic facilities that included a GMP component, of which 7742 were not conducted with a preapproval inspection.

GAO cites other problems in FDA’s inspection process of foreign drug manufacturers. “FDA does not have a dedicated staff to conduct foreign inspections and relies on those inspecting domestic establishments to volunteer. While FDA may conduct unannounced GMP surveillance inspections of domestic facilities, it does not arrive unannounced at foreign establishments,” specified Crosse. The GAO also pointed out that FDA lacks the flexibility to extend foreign inspections if problems arise. Also, FDA generally does not provide translators to its inspection teams. Instead, the agency relies on English-speaking representatives of the firm in which it is inspecting.

“We understand that FDA currently cannot inspect all foreign establishments every few years,” said Crosse. “We also recognize FDA has taken steps to improve its management of the foreign-drug inspection program by enhancing the risk-based processes it uses to select establishments for GMP surveillance inspections. In addition, FDA is pursuing an initiative that is intended to improve its identification of foreign drug establishments,” said Crosse in the written testimony. “However, until 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,” she concluded.

See related stories:

Congress Focuses on FDA Inspections of Foreign Drug Facilities

FDA Commissioner Testifies Before Congress on Foreign Inspection Process