FDA's enforcement regime is woefully inadequate. The agency is not allowed to enter into a foreign facility without an invitation. FDA has partnerships with other nations allowing it to perform inspections, but typically must give advance notice of when it will conduct an inspection. FDA is only allowed to perform inspections at facilities approved by the foreign government. Inspections of foreign facilities are shorter, and many times, inspectors must deal with language barriers.
Under such an approach, FDA would be able to spot audit API manufacturers targeting products meant for the US market. We acknowledge that this approach is not an ideal solution as the US cannot be the inspector to the world, but FDA has the burden of protecting our nation's drug supply, a burden it is currently nowhere near fulfilling.
In 2006, 1222 inspections were undertaken at domestic manufacturing facilities, compared with only 200 inspections in India and China during the past seven years combined despite the huge increases in manufacturing in these nations (2).
As globalization continues to force companies to compete with the lowest cost manufacturing, more and more manufacturing is being outsourced to overseas manufacturers. This manufacturing falls under less rigorous or nonexistent inspection processes. FDA is by default creating two different enforcement regimes. A domestic one, where manufacturers expect and receive a visit by a FDA official every two years, and a second one for outsourced APIs that are almost never uniformly inspected.
These different enforcement regimes create economic conditions putting domestic manufacturers at a distinct disadvantage. Companies operating outside of a vigorous inspection regime have no incentive to ensure the quality and safety of their products. In such an environment, US manufacturers cannot compete, resulting in cutbacks, layoffs, and closures. More and more manufacturing is sent offshore, resulting in an even greater likelihood for mishandled and poorly made APIs to reach consumers.
While we are beginning to see industry and the public notice our nation's woeful inspection processes, it is mainly in food safety and almost completely as a result of scares surrounding pet food and toothpaste contamination. APIs are sadly, not in the fast lane. Congress, industry, and consumers need to demand more accountability from the system. It is only a matter of time that a "scare" becomes a reality.
1. "Uneven Enforcement Leads to Subpar Drugs and National Security Risk," Synthetic Organic Chemical Manufacturers Association (Washington, DC) and European Fine Chemicals Group (Brussels), Aug. 2006.
2. M. Kaufmann, "FDA Scrutiny Scant in India, China as Drugs Pour Into US," Washington Post, p. A1, June 17, 2007.