SOCMA and EFCG Urge for Reform in FDA Inspections of Foreign Drug-Manufacturing Facilities

Mar 17, 2011

The Bulk Pharmaceutical Task Force (BPTF) of the Society for Chemical Manufacturers and Affiliates (SOCMA) and the European Fine Chemicals Group (EFCG) of the European Chemical Industry Council (CEFIC) are calling on FDA to mandate inspections of foreign active pharmaceutical ingredient (API) manufacturing sites with the cost borne by those sites being inspected. Both organizations have indicated a willingness to pay fees for these inspections when performed on their member-owned facilities that are located outside the United States.

In comments recently submitted to FDA, BPTF and EFCG contend “FDA is unable to keep up with globalization of the drug industry,” according to a Mar. 8, 2011, SOCMA press release. “As a result, inspections in high-risk regions like China and India are almost nonexistent when compared to the US and Europe, posing a risk to public health,” according to the release. BPTF and EFCG say that to have a sustainable foreign-inspection program, a fee for each foreign compliance inspection carried out by FDA should be collected.

BPTF and EFCG also are calling for the development of an electronic database to capture accurate information on API manufacturers selling product into the US.  Registration fees, sufficient to cover the cost of developing, compiling and maintaining this database, were suggested. “Having accurate information about API manufactures is critical to ensuring a safe drug supply,” said SOCMA in its release.

BPTF and EFCG are sector groups of SOCMA and CEFIC, respectively, and whose members include manufacturers of APIs, excipients, and intermediates.