Mismanaged Resources, Unreliable Data Hinder Foreign Inspections

Witnesses at a recent House Oversight and Investigations Subcommittee hearing said the FDA does not know how many foreign manufacturing facilities are exporting drugs to the U.S. and it is unable to inspect them adequately. One former agency employee called foreign inspections the “redheaded stepchild” of the FDA, long ignored in terms of policy updates and resources.

A lack of resources, an unreliable IT system and organizational problems all were cited as contributing to the FDA’s inability to increase foreign manufacturing inspections. The problem has gotten worse over the past few years due to expanded globalization, witnesses said.

Approximately 80 percent of active pharmaceutical ingredients are manufactured abroad, according to Subcommittee Chairman Bart Stupak (D-Mich.). However, there is no law dictating how often the FDA must inspect foreign drug manufacturers.

FDA Commissioner Andrew von Eschenbach said the agency must “revamp our entire strategy, our entire game plan” to address the problems. The FDA will adopt a global perspective and place employees in long-term assignments around the world. Those employees would work with counterpart agencies in other countries, provide technical assistance to foreign manufacturers and create partnership opportunities.