FDA has insufficient personnel and funding to adequately inspect the safety and effectiveness of prescription drugs manufactured at foreign-owned firms and imported to the U.S., according to a CongressDaily investigation. FDA's staff of drug inspectors and biologists is "stretched so thin now" that "the breadth and frequency" of inspections "cover only a fraction of the numbers needed to ensure the purity and safety of the products and to adequately ensure compliance with drug-manufacturing processes," CongressDaily reports. "Also at risk is the monitoring of foreign manufacturers and producers put on watch lists for previous questionable practices or lapses," according to CongressDaily.
CongressDaily's investigation found that the number of drug imports over the past several years has more than tripled while the number of inspectors has increased by 10%. As many as four out of 10 drugs dispensed at pharmacies in the U.S. come from manufacturing plants abroad, CongressDaily notes.
According to CongressDaily, the lack of funding and personnel might "even spoil efforts in Congress to pass legislation to permit the reimportation of cheaper prescription drugs." However, CongressDaily found that personnel employed to carry out the inspections "are quite up to the levels of competence and expertise it takes to do" them. Current Inspection Process
FDA uses a system that identifies the "riskiest foreign and domestic actors" and focuses its inspectors on those targets. Critics argue that this system is liable to fail as the number of imported drugs increases, but FDA in a statement said, "Intelligent, risk-based inspections are more important than absolute numbers of inspections."
Joseph Acker, president of the Synthetic Organic Chemical Manufacturers Association, said, "As foreign manufacturing output gets bigger, it's an impossible task for (FDA) to do," adding that a possible solution would be to "make sure other countries, as the Europeans have done, establish their own inspection requirements, equal to ours. Then we could do occasional spot checks ourselves for compliance with purity and effectiveness standards." SOCMA is affiliated with the Bulk Pharmaceuticals Task Force, which filed a petition with FDA asking the agency to increase inspections of foreign imports. The petition notes that the number of foreign inspections dropped from 249 in 2001 to 184 in 2004, despite the fact that 40% of finished drugs sold in the U.S. are manufactured abroad (Hess, CongressDaily, 6/5).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Publication Date: 2007-06-07 10:00
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