FDA IT Infrastructure Inadequate For Managing Foreign Inspections, GAO Says

FDA's ability to oversee drug importation is encumbered by an inaccurate and dysfunctional information technology infrastructure, the Government Accountability Office asserts.

GAO presented preliminary findings of an analysis identifying weaknesses in FDA's foreign drug inspection program at a House Energy and Commerce Subcommittee on Oversight and Investigations hearing Nov. 1.

The congressional watchdog group found that FDA relies on several databases to monitor and manage its inspection activities that were not designed for such a purpose and are not adequately interoperable.

The findings are part of a report addressing congressional concerns about the adequacy of inspections of imported drugs and active pharmaceutical ingredients. Foreign producers are required to meet the same manufacturing standards for quality, purity, potency, safety and efficacy as domestic manufacturers, but FDA fails to inspect foreign facilities as systematically or rigorously.

FDA is required to inspect domestic manufacturers every two years, and in practice inspects a given facility within three years on average. However, there is not a similar requirement for inspections of importing facilities.

"We found that the agency may inspect about seven percent of foreign establishments in a given year. At this rate, it would take FDA more than 13 years to inspect each foreign establishment on this list once, assuming that no additional establishments are subject to inspection," GAO Health Care Director Marcia Crosse states in written testimony.

Furthermore, "most of the foreign inspections are conducted as part of a new drug application or an abbreviated new drug application, rather than as GMP surveillance inspections, which are used to monitor the quality of 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."

"According to FDA, about 30 such inspections were completed in fiscal year 2007 and at least 50 are targeted for inspection in fiscal year 2008. Further, the data on which this risk-based process depends limits its effectiveness."

GAO identifies similar shortcomings of the program for inspecting foreign drug manufacturers as it did a decade ago in response to previous congressional oversight, including the inadequacy of data to support effective program management (¹ (Also see "FDA Foreign Inspection Program "Will Be The Next Area Of Reform" - Mikulski" - Pink Sheet, 18 May, 1998.), p. 21).

"Our preliminary results indicate that more than nine years after we issued our last report on this topic, FDA's effectiveness in managing the foreign drug inspection program continues to be hindered by weaknesses in its data systems," Crosse states.

For example, "FDA does not know how many foreign establishments are subject to inspection. FDA relies on several databases that were not designed for this purpose. One of the databases contains information on foreign establishments that have registered to market drugs in the United States, while another contains information on drugs imported into the United States. ... Despite the divergent estimates of foreign establishments subject to inspection generated by these two databases, FDA does not verify the data within each database," the GAO report states.

"Because FDA is not certain how many foreign establishments are actually subject to inspection, the percentage of foreign establishments that have never been inspected cannot be calculated with certainty," GAO adds.

FDA Commissioner Andrew von Eschenbach testified that unlike the period of GAO's previous assessment, there are now ways to integrate the disparate data systems to make the information more useful and highlighted ongoing reforms to FDA's IT infrastructure.

"We recognize that the GAO pointed out that information technology infrastructure was a problem at FDA 10 years ago, and it is a problem today. But unlike 10 years ago, today we have technologies and capabilities that didn't exist in 1997," von Eschenbach noted.

"We also have recognized the development in other spheres, of data mining techniques and the ability to crosswalk to different data systems. And our opportunity to adapt these new technologies and use new strategies in IT is exactly how we will approach and are approaching modernization of IT."

With respect to the agency's foreign drug inspection program, "there are multiple systems addressing multiple needs, but they have been developed independently with specific missions, and what has been absent is the ability to further integrate and coordinate those systems. We have been engaged in a very aggressive effort to migrate those systems into a unified coherent single FDA approach to IT technology," von Eschenbach said.

To help implement the IT infrastructure reforms, at the beginning of the year FDA hired two CMS officers with "extraordinary experience in modernizing complex information technology infrastructure" to serve as chief operating officer and chief information officer (² (Also see "FDA Gets Operations Chief From CMS As Woodcock Moves To Medical Post" - Pink Sheet, 29 Jan, 2007.), p. 16).

"We created the Bioinformatics Board at FDA to bring the operating components together to find opportunities for synergy and interoperability," the commissioner continued. One of the first tasks of the Bioinformatics Board, led by Deputy Commissioner for Operations Janet Woodcock, will be to oversee the development of a second-generation adverse event reporting system (³ (Also see "AERS Overhaul Will Be Overseen By FDA’s New Bioinformatics Board" - Pink Sheet, 20 Nov, 2006.), p. 5).

FDA is also "working with our external partners -particularly, for example, as related to inspections, our colleagues in the Department of Homeland Security/Customs and Border Protection - to further enhance our opportunities for interoperability and modernization of IT."

"And we are allocating resources to this important issue. Our 2008 budget request, currently before Congress, includes $247 million for such efforts," von Eschenbach added. "That actually accounts for 11 percent of the agency's budget devoted to modernizing and implementing the kind of information technology infrastructure ... the committee [has] been calling for."

[Editor's note: Additional coverage of the foreign drug inspections hearing, as well as recent FDA seizures, will appear in upcoming issues of "The Pink Sheet."]

- Brian Marson ([email protected])