FDA Commissioner Testifies Before Congress on Foreign Inspection Process

Washington, DC (Nov. 1)-US Food and Drug Administration Commissioner Andrew von Eschenbach testified before Congress last week to outline the agency’s inspection process for foreign drug manufacturers and efforts to improve the agency’s information technology (IT) systems.

Bart Stupak (D-MI), chairman of the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, criticized FDA’s foreign-inspection process, including its IT systems. The Subcommittee held a Congressional hearing last week.

“Since taking the position of FDA Commissioner, upgrading FDA’s IT systems has been one of my top priorities,” said von Eschenbach in a prepared statement. “We expect these improvements will help address the challenges we face in the area of foreign inspections. Logistically, foreign firms are more difficult to track and more challenging to inspect than domestic firms. The data we have regarding foreign firms is not easy to confirm or check for accuracy because we cannot easily gain access to these firms.”

FDA inspects more than 200 foreign drug manufacturers per year, said von Eschenbach. The agency has approximately 800 FDA investigators trained to conduct foreign inspections in all programs and 335 specifically trained for the drug-program area.

Although FDA tracks the importation of drug products and identifies the products’ manufacturers through its Operational and Administrative System for Import Support, von Eschenbach said that the information provided by the manufacturer often leads to duplicate entries of manufacturers or does not identify the site-specific manufacturer of the product.

“We are working on more effective and efficient solutions to ensure the accuracy and validity of the data in our registration and import IT systems,” said von Eschenbach. These measures include the establishment of the Bio-Informatics Board, the role of the Product Quality subgroup to establish accurate information on firms and their products, other measures to identify duplicate entries, and the agency’s current initiative to implement electronic registration of firms. Additionally, von Eschenbach said the Office of the Chief Information Officer is leading enterprisewide IT transformation initiatives under a two-year plan to rebuild FDA’s critical IT infrastructure.

Von Eschenbach said the FDA is also working on other measures as part of its foreign-inspection process. FDA is in the process of joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S). PIC/S fosters cooperation among pharmaceutical inspection authorities to promote harmonized GMP standards and guidance documents, training of competent authorities, and assessing and reassessing inspection authorities. FDA submitted a formal application to join PIC/S in September 2005. Acceptance in PIC/S will enable the exchange of inspection reports and other inspection information with regulatory authorities. The PIC/S application process typically takes two years.

Other developments include the establishment earlier this year of the European Union-US Bilateral Technical Working Group on Medicines Quality and Manufacturing. The focus includes using shared resources through information exchange of inspectional data for plants in the US and the European Union. Von Eschenbach also mentioned the establishment of the Interagency Working Group on Import Safety, which includes 12 federal departments and agencies that review the procedures, regulations, and practices for the safety of imported drugs, foods, and other consumer products.

China remains a concern

Despite these efforts, von Eschenbach said that China remains an area of concern. “We have limited knowledge on the quality of ingredients and products manufactured in China, as this fast-growing source is just beginning to put in place a national regulatory infrastructure,” he said. In the past four years, the number of FDA-registered drug manufacturers in China has at least doubled, he said. “Drug manufacturers in China and some other developing countries comply with [current good manufacturing practice] inconsistently and to varying degrees. Provincial authorities who conduct inspections of drug manufacturing sites in China are not always equipped with the expertise needed for this complex undertaking,” he said.

FDA and others within the Department of Health and Human Services are working with their Chinese counterparts to negotiate agreements that include commitments relating to many FDA-regulated products, said von Eschenbach.

For the story on Congressional hearings, click here.