GAO reports databases of foreign drug manufacturers are inaccurate and incompatible, requiring employees to manually check lists.
The chairman of a House oversight committee excoriated the head of the Food and Drug Administration on Tuesday for failing to ask for enough funds to conduct inspections of foreign drug manufacturing plants, including a Chinese facility that made a contaminated blood thinner that killed dozens of Americans.
Comment on this article in The Forum.Rep. John Dingell, D-Mich., chairman of the House Energy and Commerce Committee, hammered FDA Commissioner Andrew von Eschenbach for nearly 15 minutes during a hearing of the Subcommittee on Oversight and Investigations, telling him at one time that he was "carrying water for an administration which does not give you the resources you need."
The hearing was held weeks after the government learned that a contaminated blood thinner called heparin and imported to the United States might have caused the deaths of as many as 81 Americans.
To conduct biennial inspections of all foreign drug firms that export to the United States, FDA needs a budget of between $67 million and $71 million a year, according to a report the Government Accountability Office released on Tuesday. But when Dingell, pounding the dais repeatedly, asked Eschenbach, "How much do you really need to carry out your job?" Eschenbach did not answer the question directly.
When Dingell asked Eschenbach whether a budget of about $70 million would do the job, the commissioner finally concurred. Dingell then pointed out that FDA had requested only $11 million in fiscal 2008 and $13 million in fiscal 2009 for all foreign inspections. He added that FDA reported that it required only $16 million to inspect the 714 Chinese drug manufacturers that export to the United States. Dingell said he found it "indefensible" that FDA would not seek the resources "it needs to protect the American people."
Eschenbach said FDA could not approach inspections on an episodic basis and needed to conduct a "systemic overhaul of its entire process," but he did not provide details.
Dingell, in his prepared remarks, called the information technology systems that FDA uses to track and manage data on foreign drug manufacturers and the drugs they export to the United States "archaic and fraught with inaccuracies." He added the agency is unable to say how many foreign firms are subject to inspection globally, or where they are located.
Marcia Cross, director of health care for GAO, told the panel that FDA has difficulty determining the number of foreign manufacturers that sell drugs in the United States because of inaccuracies in its databases. According to FDA's Drug Registration and Listing System, about 3,000 foreign firms were registered to sell drugs in the United States in 2007, while another database, the Operational and Administrative System for Import Support, listed about 6,800 foreign firms that planned to export drugs to the United States that same year, Cross said.
She said FDA could not provide an exact number of foreign manufacturers that were subject to inspection or those that had not been inspected. This reflects the fact that the databases were designed for purposes other than managing the foreign drug inspection program, Cross said. The agency could not reconcile inconsistencies between the two databases because the systems could not exchange data, requiring workers to compare the data manually on a case-by-case basis, she said.
FDA plans to fix the problems by issuing a contract for a new Foreign Vendor Registration Verification Program, which will use an outside organization to conduct on-site verification of the registration data and product listing information of foreign companies that ship drugs to the United States, according to the GAO report. The agency had solicited proposals but had not established the criteria it would use to determine which establishments would be visited or how many establishments it would verify annually.
FDA also wants to establish a governmentwide Shared Establishment Data Service, which would provide each manufacturer with a unique identifier to help resolve database inaccuracies. To do so, FDA would have to integrate the Shared Establishment Data Service with a Customs and Border Protection system, which is under development and will not go into service until 2010, Cross said. She added that FDA officials do not have a specific timetable for deployment of the Shared Establishment Data Service.
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