FOR IMMEDIATE RELEASE
PR & Communications Department
Washington, DC – The Bulk Pharmaceuticals Task Force (BPTF), an affiliate organization of the Synthetic Organic Chemical Manufacturers Association (SOCMA) testified today on the Food & Drug Administration’s inadequate inspection regime for foreign manufacturers of drug ingredients. The testimony was before the House Energy & Commerce Committee’s Subcommittee on Oversight and Investigation.
To read the whole testimony, please go to: www.socma.com/bptf
In the testimony, John Dubeck Esq., council for SOCMA’s BPTF, told the committee the current system for regulating imported drugs is putting Americans health and safety at risk. As well as putting American manufacturers at a competitive disadvantage. Most active pharmaceutical ingredients - the ingredients that make drugs work - are manufactured overseas. In 2004, the FDA inspected only 7% of the facilities that manufacture those products, while inspecting 97% of domestic facilities every two years. Statistics bear out that foreign firms are more likely to result in significant violations than domestic firms, yet they are inspected at a much lower rate.
SOCMA’s BPTF gave the committee three recommendations to decrease the risks:
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.
2. The 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.
3. The 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.
SOCMA president Joe Acker said, “We want to thank the committee for their work on this issue and the opportunity to testify. 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. We encourage the Committee to adopt our proposal and look towards even more innovative solutions to alleviate the risks to the American consumer.”
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SOCMA is the leading trade association, serving the specialty-batch and custom chemical industry since 1921. SOCMA’s nearly 300 members employ more than 100,000 workers across the country and produce 50,000 products valued at $60 billion annually. For more information please visit www.socma.com.
ChemStewards® is SOCMA’s flagship environmental, health, safety and security (EHS&S) continuous performance improvement program. ChemStewards® was created from industry’s commitment to reducing the environmental footprint left by member’s facilities. Industry created ChemStewards® to meet the unique needs of the batch, custom, and specialty chemical industry. As a mandatory requirement for SOCMA members engaged in the manufacturing or handling of synthetic and organic chemicals, ChemStewards® is helping participants reach for superior EHS&S performance. To learn more, visit www.chemstewards.org.