FDA foreign drug review program weakened by old IT systems

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Outdated and broken IT systems are hindering the FDA's review of foreign drugs, reported former FDA officials and the Government Accountability Office (GAO) at a House Energy and Commerce Oversight Investigations Subcommittee hearing held last week.

According to the GAO, lawmakers were informed nine years ago that the FDA needed to improve its foreign drug inspection program by fixing broken IT systems. Former FDA Regulatory Counsel, Benjamin England, said that the systems remain broken.

GAO's Healthcare Director Marcia Crosse said that “FDA’s effectiveness in managing the foreign drug inspection program continues to be hindered by weaknesses in its data systems."

Crosse said that after nine years, the FDA still is unaware of how many foreign establishments are subject to inspection, and instead relies on databases not designed for this purpose. One FDA database estimated that about 3,000 foreign establishments were subject to inspection in fiscal year 2007, while another estimated that the number was 6,800, she added.

The FDA admitted to the database flaws, and acknowledged that because the databases cannot exchange information, any comparisons of the data must be performed manually, on a case-by-case basis. FDA officials told GAO that because of this, they have not generated an accurate count of foreign establishments whose drugs are imported into the United States.

FDA Commissioner Andrew von Eschenbach said the agency has sought to address these issues and he has made an IT systems upgrade for the FDA one of his top priorities. According to von Eschenbach, the FDA has requested $247 million in fiscal year 2008 for efforts “to improve technology and infrastructure related to inspections of foreign companies that manufacture medications or medication components imported by the United States.”