John DiLoreto
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The bipartisan enactment of the Food and Drug Safety and Innovation Act, signed into law on July 9, 2012, is an important
achievement in FDA's objective to ensure the efficiency and quality of drugs manufactured and distributed in the US and abroad.
For generic drugs, the legislation makes it possible for the federal government to increase foreign facility inspections,
speed approval of lifesaving medicines, reduce drug shortages, and improve the quality and availability of drug ingredients.
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.
