In a move to better protect public safety, SOCMA's Bulk Pharmaceutical Task Force (BPTF) and European Chemical Industry Council's Fine Chemicals Group (EFCG) are calling on the Food and Drug Administration (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 outside the U.S.

In comments recently submitted to the Agency, BPTF and EFCG argued that the FDA is unable to keep up with globalization of the drug industry. As a result, inspections in high-risk regions like China and India are almost non-existent when compared to the U.S. and Europe, posing a risk to public health.

In order to have a sustainable foreign inspection program, a fee for each foreign compliance inspection carried out by Agency should be collected.
BPTF and EFCG also called for the development of an electronic database to capture accurate information on API manufacturers selling product into the United States. 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.

BPTF and EFCG are sector groups of SOCMA and CEFIC respectively, whose members include manufacturers of active pharmaceutical ingredients (APIs), excipients and intermediates. One of the primary objectives of both groups is to interact with government agencies on emerging issues that affect members.

For more information, contact Guy Villax, EFCG, at [email protected] or John DiLoreto, BPTF, at [email protected]. For information on BPTF, or topics relating to current good manufacturing practices of APIs, visit www.socma.com/bptf.