Unreliable Data, Mismanaged Resources Hinder Foreign Inspections, Witnesses Say

The FDA does not know how many foreign manufacturing facilities are exporting drugs to the U.S. and is unable to inspect them adequately, witnesses at a House Oversight and Investigations Subcommittee hearing said. 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 that go into drugs 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.

One of the major problems is the FDA’s IT system, which is unorganized and contains unreliable information, preventing the agency from properly allocating resources for foreign inspections, Stupak said. Over the last three months, the FDA gave Congress 10 different numbers of facilities exporting to the U.S., ranging from 2,100 to 13,800, he added.

Rep. John Dingell (D-Mich.) has introduced a bill that would establish a user fee for each line of imported products. Stupak, a co-sponsor of the bill, said the legislation would provide an additional $300 million to the agency.

However, witnesses warned against seeing the legislation as a panacea. A user fee could help, but the funding should be dedicated to the agency’s IT system and a smaller amount than stated in the bill would still be useful, former Director of the Office of Regulatory Affairs’ Division of Import Operations Carl Nielsen said.

While the FDA needs more resources to increase foreign inspections, a user fee could decrease appropriated funding for the agency, Coalition for a Stronger FDA Senior Adviser William Hubbard added. 

In its fiscal 2008 budget request, the FDA asked for $247 million to modernize and implement its IT system.