SOCMA Applauds FDA Drug Import Safety Program - More Work Still Needed
FOR IMMEDIATE RELEASE
January 14, 2009
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Assistant Manager, Communications
Washington, DC – The Synthetic Organic Chemical Manufacturers Association (SOCMA) reacted today to the Food and Drug Administration’s (FDA’s) announcement of its Secure Supply Chain pilot program. The two-year voluntary pilot program is intended to help the FDA promote the safety of drugs and active drug ingredients produced outside the United States, assist the agency in its efforts to prevent the importation of contaminated or counterfeit drugs and help concentrate its resources on companies that pose the highest risk of importing unsafe products. SOCMA issued the following statement:
“The launch of the Secure Supply Chain pilot program is a welcome enhancement to the security of the U.S. drug supply chain. If successful and permanently implemented, the risk of adulterated or counterfeit drugs or drug ingredients entering the U.S. could be substantially diminished. Foreign manufacturers currently profiting from a lack of discipline in current Good Manufacturing Practices (cGMP) may finally have incentive to apply the necessary principles for meeting U.S. drug quality standards.
“The pilot program is also a welcome enhancement to FDA’s ‘Beyond Our Borders’ program, an initiative to establish inspection offices in foreign countries with limited ability to provide regulatory oversight of manufacturing firms. We encourage the FDA to continue its efforts to increase vigilance through collaborative relationships with foreign governments.
“While we applaud the agency’s cooperation with the Interagency Work Group on Import Safety, SOCMA maintains that increasing the number of foreign inspections is an integral part of securing the nation’s drug supply and leveling the global business playing field for U.S. manufacturers. Meeting the cGMP expectations of the FDA requires a significant investment in infrastructure, training and knowledge base that many foreign firms lack.
“Additionally, foreign firms should be integrated with domestic firms into one risk ranking system. This will ensure the FDA’s ability to focus resources on any firm posing the greatest risk to the U.S. drug supply. Another initiative FDA should consider is a program to monitor the impurity profiles of imported over-the-counter drugs for patterns that create the appearance of underlying cGMP violations – in lieu of inspections of manufacturers without New Drug Applications or Abbreviated New Drug Applications and respective Drug Master Files.
“SOCMA also cautions the FDA from turning this innovative program into a mechanism for foreign producers to obtain a competitive edge over US manufacturers. By extending the advantage of an expedited review in addition to not subjecting participants to the rigors of a full domestic FDA inspection, the program may give or appear to give foreign firms a business advantage over domestic producers.”
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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.com.