GAO evaluates FDA’s overseas inspectors

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

A couple of new GAO reports are seeking to shed some light on the FDA’s overseas regulatory efforts. The first is part overview, part progress report (52-page PDF). It’ll answer your basic questions.

September 18, 2007: An FDA chemist is shown conducting a rapid screening using an automated immunoassay instrument to detect cell surface antigens of Salmonella on food products. Photo by Black Star/Michael Falco for FDA

An FDA chemist tests food for antigens of Salmonella. (Photo: Black Star/Michael Falco for FDA)

In 2008 and 2009, the FDA sent 42 staffers overseas to establish foreign offices. The staff are on two-year overseas rotations, though it’s been difficult to find qualified workers for certain locations, especially since some of them had to take a pay cut. There’s a map of all 11 offices on the 12th page of the PDF.

According to the GAO, what do FDA overseas offices do?

  • Build relationships with foreign regulators and stakeholders, and with other U.S. agencies that are overseas
  • Gather information about regulated products
  • Inspect overseas facilities which are exporting to the U.S. (China and India only)
  • Train foreign stakeholders to better understand FDA regulations and systems

The second report is focused specifically upon inspections of overseas drug manufacturers producing for the U.S. market. The FDA has prioritized a list of such facilities that it would like its inspectors to visit, and the overseas agents managed to check off 11 percent of that list last year. At that rate, it will take about nine years for them to cover everything. For domestic facilities, that turnover rate is about 2.5 years.

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.