Senator Questions FDA's Foreign Inspections

August 16, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

Senator Chuck Grassley (R-IA), a ranking member of the Senate Committee on Finance, asked the US Food and Drug Administration to explain what steps it is taking to ensure the safety of medicine manufactured outside the United States.

Washington, DC (Aug. 9)-Senator Chuck Grassley (R-IA), a ranking member of the Senate Committee on Finance, asked the US Food and Drug Administration to explain what steps it is taking to ensure the safety of medicine manufactured outside the United States. In a letter to Commissioner Andrew von Eschenbach, Grassley said he was disturbed by reports that described FDA inspections of foreign pharmaceutical manufacturing facilities as inadequate. “This is a significant problem that needs to be addressed immediately,” said Grassley, commenting that roughly 80% of the active pharmaceutical ingredients (APIs) used in the United States are manufactured abroad.

In his letter, Grassley also noted that concerns about FDA’s oversight of foreign drug-manufacturing facilities were not new. He cited a 1998 report written by the Government Accountability Office in response to questions about FDA’s power to ensure the safety and quality of foreign-produced drugs imported into the US. “The fact that this problem persists nearly 10 years after this report was published is unacceptable,” Grassley said.

The Senator asked for formal responses to questions, including:

  • What specifically does FDA do when it inspects a foreign pharmaceutical-manufacturing facility?

  • How many on-site visits of foreign pharmaceutical manufacturing facilities has FDA performed since 2002 and who performed them?

  • What action is taken when an inspection results in negative findings?

  • How does FDA cooperate with its foreign counterparts or other foreign regulatory bodies?

  • What strategies is FDA developing to improve the inspection of foreign pharmaceutical plants, and what is the timeline for the implementation of these strategies?

  • How is FDA preparing to respond to the expected shift of manufacturing from domestic to Asian facilities?

Read the full text of Senator Grassley’s letter.