US Congress hears drug import safety report from SOCMA
The Synthetic Organic Chemical Manufacturer\'s Association\'s (SOCMA) Bulk Pharmaceutical Task Force have testified before the House Energy and Commerce Subcommittee about a lack of FDA inspection of overseas plants used in active pharmaceutical ingredients (API) manufacture.
The Synthetic Organic Chemical Manufacturer's Association's (SOCMA) Bulk Pharmaceutical Task Force have testified before the House Energy and Commerce Subcommittee about a lack of FDA inspection of overseas plants used in active pharmaceutical ingredients (API) manufacture.
Council for SOCMA's BPTF, John Dubeck, testified that APIs made in foreign facilities are rarely inspected by the FDA, especially in the case of ingredients going into over-the-counter drugs.
Under US and European law, domestic facilities before beginning manufacturing must be inspected. 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 otc medication ingredients have never seen an FDA inspector, said Dubeck.
The BPTF is an industry trade organisation for US-based API and excipient manufacturers. It was created in 2002 as an affiliate organisation of SOCMA, and 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.
SOCMA has nearly 300 members across the country, produce products valued at $60bn annually.
