House questions FDA foreign oversight

The House Committee on Commerce conducted a Commerce Oversight and Investigations Subcommittee hearing on counterfeit bulk drugs to inquire into the Food and Drug Administration's oversight into foreign drug imports.

"I am very concerned about how counterfeit, unapproved or substandard drugs could be getting into the United States," Tom Bliley (R-VA) said in announcing the hearing. "The FDA's reactionary approach to counterfeit imports has been entirely too little too late. Instead of deterring problematic drug imports with investigations of counterfeiting networks and tying import admissibility to manufacturing quality, [the] FDA has waited until adverse event reports have trickled in."

The call for the hearing came after the FDA admitted having information on only 18% of foreign drug manufacturers shipping to the United States, and that there are about 4,600 foreign drug manufacturers that have shipped to the United States since October 1997. These manufacturers, including 623 in China and 409 in India, have never been inspected by the FDA.

At the hearing, John Taylor, the FDA's associate commissioner for regulatory affairs, defended his organization, "The overall quality of drug products in this country is very high. However, [the] FDA takes very seriously allegations regarding the counterfeiting or adulteration of drug products. We recognize that more can be done to quantify the scope of the problem counterfeit bulk drugs may pose in the U.S. market, and strengthen our regulatory or enforcement activity, when warranted."

Taylor conceded that more could be done to address the committee's concerns. "Building and maintaining a strong the regulatory framework and tools to address the entries from foreign countries is complex, and the Agency needs to have the flexibility to change as the global market changes," Taylor said. "A healthy regulatory and enforcement system requires significant staff and resources, staff expertise, scientific methodologies and the tools to conduct testing, information systems and access to information via established networks with other countries and the industry. While [the] FDA has done much in the past few years to address both the general challenges in having a strong and viable foreign inspection program and the specific tools needed to combat counterfeit drugs, clearly more can be done." PR