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The current system for regulating imported drugs is putting consumers' health and safety at risk.
The current system for regulating imported drugs is putting American consumers' health and safety at risk, according to a testimony by the Bulk Pharmaceutical Task Force (BPTF), an affiliate organization of the Synthetic Organ Chemical Manufacturer's Association (SOCMA). Earlier this month, BPTF testified on FDA's inadequate inspection regime for foreign manufacturers of drug ingredients. The hearing, entitled 'FDA Foreign Inspection Program: A System At Risk', was held in Washington, DC, (USA) before the house energy and commerce committees's subcommittee on oversight and investigation.
Most APIs are manufactured overseas, but in 2004 only 7% of foreign facilities were inspected by FDA, compared with 97% of domestic companies. In the testimony, John Dubeck, council for BPTF said: "Statistics presented at a cGMP Conference in 2005 indicate that cGMP inspections of foreign firms result in significantly more violations than seen in domestic firms. When comparing pre-approval inspections, the same discrepancy is seen: deviations from cGMP were more serious in foreign facilities."
The committee has been given three recommendations to decrease risks:
Foreign and US firms should be ranked together for risk profiling to determine inspections. Currently, there are two lists: domestic and foreign, with domestic companies being inspected more often.
Foreign manufacturing should be classified as a higher risk factor because many emerging markets do not have a strong regulatory regime.
FDA should monitor and test impurity profiles for APIs produced in facilities not inspected by them. Although an imperfect solution, it will be a vast improvement compared with the current system and will allow FDA to see if impurity profiles for a facility change over time.
Joe Acker, SOCMA president, says: "We are pleased that congress has taken up this issue and is allowing us to relate our concerns about the lack of enforcement for foreign manufacturers of active ingredients. This issue has serious implications. Other nations have seen what can happen when regulatory bodies do not properly enforce existing rules."