SOCMA Comments on FDA Deficiencies
FOR IMMEDIATE RELEASE
February 5, 2008
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Washington, DC – The Synthetic Organic Chemical Manufacturers Association (SOCMA) and the Bulk Pharmaceuticals Task Force (BPTF) submitted comments to the Food & Drug Agency discussing the recent FDA Science Board report: FDA Science and Mission at Risk. Click here for SOCMA’s full comments.
SOCMA and the BPTF applaud the Science Board’s report recognizing the serious deficiencies within the FDA. This report is only one in a long string of reports demonstrating the inefficiencies of the Agency, its lack of focus on manufacturing quality, and poor internal management. The report correctly points out the Agency’s need of serious investment to overhaul its management, find new ways to retain quality staff, and inject new modes of thinking into how the Agency should carry out its mission.
However, SOCMA and the BPTF are disappointed the report did not adequately address a key issue facing the agency: the inspection of foreign facilities manufacturing active pharmaceutical ingredients (API’s). While the report details the need for greater scrutiny of the development of new products and greater post-market surveillance ensuring the general safety of the manufactured drugs, it does not provide enough detail describing the need for inspecting the process of manufacturing drugs and their ingredients after the safety trials are completed and manufacturing is approved. This is particularly noteworthy for over the counter medications (OTC) and generics.
For more information on emerging market quality issues of API’s and the FDA response, please go to: www.socma.com/bptf.
SOCMA is the leading trade association for the specialty-batch chemical manufacturing industry and represents over 300 member companies. The BPTF is a subgroup within SOCMA representing the manufacturers of active pharmaceutical ingredients (API’s).
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.
What Members Are Saying…
“Right off the bat, SOCMA’s ChemStewards provides you with a template that shows you good practices that should be implemented across-the-board. And the dialogue with other members and SOCMA staff is very valuable. You would have to pay a lot of money to bring in that kind of expertise, but with SOCMA, it’s all a benefit of membership.”