GAO Report Blasts FDA for Failure to Implement 2008 Recommendations

October 31, 2010

By Jennifer B. Davis

Earlier this week, the Government Accountability Office (“GAO”) publicly released its September 2010 Report to the House Committee on Oversight and Government Reform concerning Drug Safety, titled “DRUG SAFETY – FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed.”  The latest in GAO’s “High-Risk Series” of reports, the report sharply criticizes FDA for persistent shortcomings in its oversight and inspection of foreign drug establishments – functions essential in GAO’s view to “safeguarding the nation’s drug supply in today’s global marketplace.” 

The report details the findings of a GAO performance audit initiated in November 2009 at the House Committee’s request to evaluate FDA’s progress in: (1) conducting more foreign drug inspections; and (2) strengthening the data it uses to oversee and manage the foreign drug establishment inspection program.  Both recommendations were included in two previous GAO reports issued in 1998 and 2008 (here and here).  The latest, September 2010 report faults FDA for failing to implement GAO’s prior, specific recommendations and for otherwise failing effectively to address the “long-standing challenges” in its foreign drug inspection program, which, GAO emphasizes, “are not new, as [its] prior work shows.”  The report concludes that “it is urgent that FDA implement GAO’s prior recommendations to better protect public health.”
In particular, GAO’s audit found that while FDA committed significantly more resources to foreign drug inspections in 2009 ($41 million compared to $10 million in 2007 and $12 million in 2008), and, largely through a cadre of inspectors dedicated to foreign inspections, increased the overall number of foreign drug inspections conducted in fiscal year 2009 (424 compared to 333 in 2007 and 324 in 2008), that number nevertheless represented only 11 percent of the foreign drug establishments that FDA had identified as being subject to inspection.  In contrast, during the same time period, FDA conducted 1,015 domestic drug establishment inspections, representing roughly 40 percent of domestic drug establishments.  GAO additionally found that most foreign drug establishment inspections conducted in 2009 were pre-approval inspections focused on the manufacturing process for a drug product not yet in the U.S. market, as compared to comprehensive, good manufacturing practice inspections checking on the conditions of manufacture for drug products already in U.S. commerce.  The report criticizes the agency’s “pre-approval” approach to selecting foreign establishments for inspection as inconsistent with GAO’s 2008 recommendation that “FDA inspect, at a comparable frequency, those establishments that are identified as having the greatest public health risk potential if they experience a manufacturing defect, regardless of whether they are a foreign or domestic establishment.”  According to the report, the majority of foreign establishments in FDA’s inventory, almost half of which are located in China and India, may never have been inspected.

With regard to the data that FDA uses to manage the foreign establishment inspection program, GAO found that the agency continues to rely on sometimes inaccurate or incorrect information from multiple databases to annually compile an inventory of foreign drug establishments subject to inspection, and does not maintain a separate listing of such establishments.  While GAO acknowledges that FDA has taken initiatives to improve its information on foreign establishments – e.g., switching from a paper-based to an electronic registration and listing database; requesting that establishments voluntarily provide a unique Dun and Bradstreet Data Universal number to improve tracking; and collaborating with foreign regulatory authorities on the exchange of inspection information, it concludes that “these steps appear to involve long-term efforts . . . in their early stages and it is unclear if these efforts will prove successful.  In the meantime, FDA’s data systems continue to contain inaccurate information on foreign establishments, compromising the agency’s oversight of the nation’s drug supply.”

More notable, perhaps, than the report’s particular findings with regard to FDA oversight of foreign drug establishments, is GAO’s expression of its much broader concern about the adequacy of FDA’s medical product oversight in general.  GAO states in the report that “[d]ue in part to the concerns raised in our September 2008 report, in January 2009, we added FDA’s oversight of medical products – drugs, biologics, and medical devices – to our High-Risk Series, citing FDA’s ability to ensure the quality of medical products manufactured overseas as an area of particular concern.  Our subsequent reports have reinforced these designations of FDA as an agency in need of broad-based transformation by identifying additional concerns with FDA’s ability to manage its growing responsibilities and plans for modernizing the agency’s information technology capabilities.” 

In comments on the GAO report, FDA’s parent agency, the Department of Health and Human Services (“HHS”), states that it “agrees that more progress is needed in order to meet the challenge of safeguarding the nation’s drug supply in today’s global marketplace,” and identifies several initiatives undertaken by FDA to more effectively secure the drug supply chain, including FDA’s enhanced global presence and international collaboration and capacity.  Despite some progress, however, HHS notes that “[t]he sheer number of foreign facilities, the complexity of the drug supply chain, and the rapidly changing use of suppliers all pose formidable obstacles to implementing GAO’s recommendation that FDA conduct foreign inspections at a rate comparable to domestic inspections.”  How formidable?  Well, according to HHS, “FDA has estimated that if it were to conduct Good Manufacturing Practices (GMP) surveillance inspections at a rate comparable to domestic GMP surveillance inspections, the inspection frequency for both, under current resources, would be, at most, about once every 7 years.”