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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
The Bulk Pharmaceuticals Task Force, an affiliate of the Synthetic Organic Chemical Manufacturers Association (SOCMA) weighed in on the Congressional debate concerning the US Food and Drug Administration?s inspection process of foreign drug- manufacturing facilities.
Washington, D.C. (Nov. 1)-The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Synthetic Organic Chemical Manufacturers Association (SOCMA) weighed in on the Congressional debate concerning the US Food and Drug Administration’s inspection process of foreign drug- manufacturing facilities. SOCMA is the US-based trade association representing batch and custom manufacturers, which includes producers of active pharmaceutical ingredients and intermediates.
John Dubeck, council for SOCMA’s BPTF testified before the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigation earlier this month. The subcommittee held a hearing about FDA’s foreign-inspection process that was intended to evaluate the agency’s effectiveness in overseeing foreign inspections and the agency’s resource allocation for this function. See story in the Nov. 8, 2007, ePT “Congress Focuses on FDA Inspections of Foreign Drug Facilities.”
In a prepared statement, SOCMA highlighted three recommendations made by the BPTF to decrease the risk in FDA’s inspection process:
1) Rank the foreign firms and the US firms together for risk profiling to determine inspections. “Currently, the FDA maintains two lists: one foreign, one domestic, and mainly inspects the domestic firms. By merging the lists, foreign firms that have a higher risk profile would be inspected before a US firm with a much lower profile,” said SOCMA in an association release.
2) FDA should classify foreign manufacturing as a higher risk factor. “Many emerging markets do not have a strong regulatory regime, so firms operating in those countries should be classified as a higher risk,” said SOCMA.
3) FDA should monitor and test the impurity profiles for active ingredients produced in facilities not inspected by the FDA. “While this is admittedly an imperfect solution, it is a vast improvement over the current system. This would allow the FDA to see if impurity profiles for a facility change over time which would demonstrate a facility does not have control processes in place warranting an inspection,” said SOCMA.
Dubeck’s full testimony before Congress may be found here.
“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,” said Joe Acker, president of SOCMA in an association release. “This issue has serious implications. Other nations have seen what can happen when regulatory bodies do not properly enforce existing rules. We encourage the Committee to adopt our proposal and look toward even more innovative solutions to alleviate the risks to the American consumer.”
SOCMA is taking an active role in seeking reform within FDA regarding foreign inspections. In September 2006, SOCMA’s BPTF filed a citizen’s petition against FDA calling for increased inspections of foreign facilities. Following the petition, the BPTF, SOCMA, and the European Fine Chemicals Group released a joint white paper in October 2006 also calling for more inspections of foreign drug-manufacturing facilities.
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