Old tools hamper drug inspections, observers say
The testimony was presented at a House Energy and Commerce Oversight and Investigations Subcommittee hearing on FDA's inspection program.
FDA's import electronic screening system "is screening against present data. It is not monitoring products," said Benjamin England, a 17-year FDA veteran who left his most recent position as regulatory counsel in July 2003.
Eight years ago, when the FDA came before Congress to answer questions about the same topic, lawmakers were told that the agency's drug import programs and its IT systems were broken, England said, adding that they remain broken today.
The stand-alone systems, containing data in incompatible formats, are largely the result of a lack of integration within the FDA itself, England added. Many of the witnesses said "the missing piece" in the broken program is funding.
England said any action the subcommittee takes should first include a significant investment for re-engineering FDA's IT systems.
Marcia Crosse, the Government Accountability Office's healthcare director, said that "it's certainly true that resources" are "a major constraint here." Her testimony noted that GAO's preliminary results indicate that more than nine years after GAO last reported on the topic, FDA still does not know how many foreign facilities are subject to inspection.
One database calculated that about 3,000 establishments could have been subject to inspection in fiscal 2007, while another put the number at about 6,800, Crosse testified. Despite such disparate estimates, FDA uses the data to generate a list of 3,249 establishments when prioritizing facilities for inspection.
Former FDA Associate Commissioner William Hubbard, who left the agency in 2005, said a relatively small investment in IT funding could make oversight far more effective.
FDA Commissioner Andrew von Eschenbach said in written testimony that since taking his position last December, upgrading FDA's IT systems has been one of his top priorities. He added that data on foreign firms is hard to confirm because the agency cannot easily gain access to those firms.
Also, information provided by importers often leads to duplicate entries because of name, configuration and address changes. Eschenbach noted that FDA has created a board to address the data accuracy issues, adding that the agency's IT chief is crafting a two-year plan to overhaul the IT infrastructure.
"Despite the challenges which face us, the American drug supply continues to be among the safest in the world," Eschenbach stated.
Rep. Michael Burgess, R-Texas, a physician, said, "The FDA does not shoulder all the blame in this situation," when many people, including those in Congress, could not have anticipated the influx of drug imports coming into the United States.