FDA Inspection System For Foreign Drugs Broken, Say Experts

It seems lawmakers did nothing to fix a broken system meant to keep us safe. FDA Inspection System For Foreign Drugs Broken, Say ExpertsBy Cliff Montgomery – Nov. 13th, 2007Obsolete information technology systems have hampered foreign drug inspections by the Food and Drug Administration (FDA), both former department officials and the administration’s watchdog agency recently testified.The Nov. 1st testimony was given at a House Energy and Commerce Oversight and Investigations Subcommittee hearing regarding the FDA’s inspection program.FDA’s electronic screening system for imports “is screening against present data. It is not monitoring products,” stated Benjamin England, a 17-year department veteran who moved up the ranks to serve as the FDA’s regulatory counsel until leaving the post in July 2003.When FDA officials last came before Congress eight years ago, it was to answer lawmakers’ questions on the same topic. The officials testified that the department’s drug import methods and  information technology (IT) systems were broken–and they are still broken eight years later, said England.Much of the problem is that the various IT systems run on incompatible formats–a mistake largely caused by a lack of unity inside the FDA itself, testified England. Several witnesses added that “the missing piece” in the department puzzle is proper funding.England appeared to agree with this assessment, stating that any action taken by the panel must begin with the strong investment needed to re-engineer FDA’s IT systems.Marcia Crosse, healthcare director for the Government Accountability Office (GAO), testified that “it’s certainly true that resources” have become “a major constraint here.”She stated that early results reveal a frightening fact: The FDA has no idea how many foreign establishments are under the jurisdiction of department officials, even though the GAO first told lawmakers about this problem over nine years ago.One department database reported that around 3,000 establishments may have been under the jurisdiction of U.S. inspectors in fiscal 2007–but another calculated that number at about 6,800, stated Crosse. Despite such obvious inconsistencies, the FDA utilized the information to create a prioritized list of 3,249 facilities for inspection.William Hubbard, a former FDA Associate Commissioner who left the department in 2005, told lawmakers that a modest IT funding investment may aid in making U.S. oversight of foreign drug products far more effective.FDA Commissioner Andrew von Eschenbach, who only began the job last December, stated in written testimony that fixing the FDA’s faulty IT systems has become a top priority. He also told House members that confirming information on foreign firms is difficult, as the department does not have an immediate access to those companies.Eschenbach added that data provided by foreign firms often leads to a confusion of duplicate entries thanks to configuration, name and address changes. He further stated that the FDA has established a panel to consider the data inconsistencies, and that the department’s head of information technology is putting together a two-year strategy to remake the IT infrastructure.”Despite the challenges which face us, the American drug supply continues to be among the safest in the world,” Eschenbach said–but as countries with lax safety procedures continue to flood the international drug market, it’s getting harder to gauge the truth of such statements.Rep. Michael Burgess (R-TX), a former practicing physician, told fellow lawmakers: “The FDA does not shoulder all the blame in this situation,” since several people–including lawmakers themselves–had no way of knowing just how many drug imports would come into the United States.But Rep. Burgess was simply putting forth an irrelevant statement to confuse the issue, rather than to clarify it. The issue never was about massive numbers, but about basic oversight–or the lack of it.Lawmakers must have known for years that emerging countries like China may well be selling drugs of a potentially poor quality; and they’ve long known that such drugs would be overseen by an FDA system that is fundamentally broken.No lawmaker or department head–including Representative Burgess–may claim ignorance of this issue. And yet for more than nine years, it seems they did nothing to fix a broken system meant to keep us safe.Like what you’re reading so far? Then why not order a full year (52 issues) of thee-newsletter for only $15? A major article covering an story not being told in the Corporate Press will be delivered to your email every Monday morning for a full year, for less than 30 cents an issue. Order Now!