FDA Has Not Inspected Many Foreign Companies That Manufacture Medications, Medication Ingredients Imported To U.S., GAO Report Finds

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 05 Nov 2007 - 7:00 PDT

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FDA this year has not visited as many as two-thirds of foreign companies that manufacture medications or medications components imported by the U.S. subject for inspection, according to a report from the Government Accountability Office released on Thursday during a hearing of the House Energy and Commerce Oversight and Investigations Subcommittee. Under current law, FDA must inspect U.S. companies that manufacture medications or medications components at least once every two years, but no such requirement exists for inspections of foreign companies, although an estimated 80% of medication ingredients and 40% of medications sold in the U.S. are imported (Bridges, AP/San Francisco Chronicle, 11/1).

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

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

Testimony
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's effectiveness in managing the foreign drug inspection program continues to be hindered 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).

CBS' "Evening News" on Thursday covered the report. The segment includes comments from Nielsen; former FDA Commissioner William Hubbard of the Coalition for a Stronger FDA; and von Eschenbach (Reid, "Evening News," CBS, 11/2). Video of the segment is available online.

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