FDA Has Not Inspected Many Foreign Companies That Manufacture Medications

Armen Hareyan's picture

FDA this year has not visited as manyas two-thirds of foreign companies that manufacture medications or medicationscomponents imported by the U.S. subject for inspection, according to a reportfrom the Government Accountability Office released onThursday during a hearing of the House Energy and Commerce Oversight and Investigations Subcommittee.Under current law, FDA must inspect U.S. companies that manufacture medicationsor medications components at least once every two years, but no suchrequirement exists for inspections of foreign companies, although an estimated80% of medication ingredients and 40% of medications sold in the U.S. areimported (Bridges, AP/San Francisco Chronicle,11/1).

According to the report, FDA used information from two databases -- one thatcontains 3,000 foreign companies that manufacture medications or medicationscomponents imported by the U.S.and one that contains 6,800 -- to compile a list of 3,249 foreign companiessubject for inspection this year. However, FDA has inspected only 7% of thoseforeign companies, the report said (Edney, CongressDaily,11/1). The report said that FDA "could not identify a previousinspection" for 2,133 of those foreign companies. In addition, the reportestimated that, at the current rate, FDA would require 13 years to inspect allof those companies.

The report also said that FDA officials could not determine the exact number offoreign companies overseen by the agency (Wilde Mathews, Wall Street Journal, 11/2). GAOreleased a similar report in 1998.



At the hearing, Marcia Crosse, director of health care for GAO, said,"More than nine years after we issued our last report on this topic, FDA'seffectiveness in managing the foreign drug inspection program continues to behindered by weaknesses in its data systems" (Bogdanich, New York Times, 11/2).

Subcommittee Chair Bart Stupak (D-Mich.) asked, "How can we have any confidence FDA is truly managing the risk that may come from foreign-made drug products if the FDA doesn't know the exact number or location of foreign drug manufacturers?" (AP/San Francisco Chronicle, 11/1).

FDA Commissioner Andrew von Eschenbach said that the agency has sought to address the issues. He said, "We recognize that the world is evolving and our local markets now provide products largely from a global marketplace" (New York Times, 11/2). According to von Eschenbach, 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 medications components imported by the U.S.

Carl Nielsen, a former FDA official who served at the agency for almost 30 years, said, "The imports have tripled, but the FDA resources have remained the same" (Walker, CQ HealthBeat, 11/1).

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