A risky market
In the past, the US drug supply has been susceptible to sub-par quality drugs due to the lack of enforcement of basic drug quality inspections of foreign facilities—leading to lax quality compliance standards. According to FDA, approximately 80% of APIs are imported, primarily from high-risk regions, such as Asia (1, 2). FDA has been unable to accurately identify all foreign facilities manufacturing drugs entering the US, and the agency does not have the resources or systems in place to track such foreign facilities for the purpose of quality inspections.Although domestic pharmaceutical companies can expect an FDA inspection every two to three years, most of their foreign counterparts have never been inspected by FDA. According to a 2010 GAO report (3), it would take FDA, with current resources, more than nine years to inspect all foreign facilities just once. The lack of routine risk-based inspection of foreign facilities endangers the safety of the global drug supply chain, encourages non-domestic job growth, and has the potential of becoming a national security issue.
FDA gains resources
With the passage of the FDA reform bill, the agency indicated in negotiations with stakeholders that it will have the resources it needs to inspect all foreign and domestic generic-drug production facilities with regularity (4).
Inspections will be performed on a risk basis, focusing on the facilities posing the greatest risk to the supply chain. This will provide greater confidence in the safety of generic drugs imported from developing countries.
Members of the Bulk Pharmaceuticals Task Force (BPTF), an industry trade organization of drug ingredient makers within the Society of Chemical Manufacturers and Affiliates, will be among those paying FDA nearly $1.5 billion over the course of five years to accomplish these goals. The Generic Drug User Fee Act (GDUFA), which was negotiated last year by BPTF members and other industry trade groups, is included in the FDA Reform Act. GDUFA will expedite the availability of more affordable, high-quality generic drugs; enhance FDA's ability to prevent substandard and misbranded drugs from entering the supply chain; and level the playing field between foreign and domestic firms.
Significantly, the legislation also authorizes FDA to confiscate and destroy counterfeit, adulterated, or misbranded drugs that enter the US rather than returning them to foreign manufacturers. Past practices forced FDA to send the drugs back to their country of origin, where they were ultimately returned to the drug supply chain in other countries.