FDA inspection data on nearly 1,000 overseas drug firms is missing

The US Food and Drug Administration (FDA) has improved the process of vetting overseas companies that sell drugs to the US, but key challenges remain, according to a new report from the congressional Government Accountability Office (GAO).

The FDA’s catalogue of foreign drug establishments with no inspection history is now at 33% – almost 1,000 out of approximately 3,000 such establishments – compared to 64% in 2010.

Also troubling to the GAO is the persistently high vacancy rates at the FDA’s foreign offices. Its report concluded that 46% of positions in these foreign offices were vacant, as of July 2016.

Key congressmen on Capitol Hill have taken notice of the GAO’s findings. ‘The FDA has made some significant improvements over the last 10 years to their handling of the foreign drug inspection programme, but more work lies ahead,’ stated the Republican chair and top Democrat on the House of Representatives’ Energy and Commerce Committee. Chairman Greg Walden and ranking member Frank Pallone said the number of foreign drug firms that the FDA has no information on is ‘sizeable and very troubling’.

This data gap is especially significant because 80% of US drug ingredients now come from abroad and nearly 40% of finished US drugs are currently made overseas, the congressional committee warned.