This press kit offers information on SOCMA’s Bulk Pharmaceuticals Task Force (BPTF) and the actions it has taken concerning emerging markets product quality.
Many active pharmaceutical ingredients (API’s) made in foreign facilities are rarely inspected by the U.S. Food and Drug Administration, especially in the case of ingredients going into over-the-counter drugs. Under U.S. law, domestic facilities must be inspected before they begin manufacturing. The majority of foreign facilities manufacturing API’s used in generic medications rarely see an FDA inspector after an initial inspection. Most foreign manufacturers of over-the-counter medication ingredients have never seen an FDA inspector.
BPTF first took action in 2006 by submitting a Citizen’s Petition to the Food and Drug Administration calling for increased inspections of foreign facilities That action was followed by the publication of a joint white paper by BPTF, SOCMA, EFCG.
Below, are materials the BPTF have made available to the public. For questions, please contact SOCMA.
SOCMA’s Bulk Pharmaceuticals Task Force (BPTF) is an industry trade organization for U.S. manufacturers of active pharmaceutical ingredients (APIs), their intermediates and excipients. Created in 2002 as an affiliate organization of SOCMA, its primary objective is to seek clarification of current regulatory requirements and to interact with governmental agencies on emerging issues that may impact SOCMA members.
Congressional Testimony and Comments
SOCMA-EFCG White Paper
This paper discusses the poor quality of the FDA inspection regime and cites a number of figures to demonstrate the FDA's inabilities.
BPTF/SOCMA files comments on FDA Science Committee Report: FDA Science and Mission at Risk
The report is an honest look at the issues facing the FDA.
BPTF files comments to the FDA on Generic Drug User Fees