FDA weak on foreign pharma plant oversight

Difficulties at Ranbaxy Laboratories, a major generic pharmaceutical company in India, has fueled interest into FDA oversight of foreign drugs. While the agency issues warning letters, it fails to follow up and that it does not keep accurate records, according to a report by the Government Accountability Office (GAO). In fact, the FDA ban on importing 30 of Ranbaxy's generic drugs came years after the first documented quality concerns at the plants. 

The FDA has only issued 15 warning letters to foreign companies from 2002 to 2007 (both fiscal years), re-inspecting just four of the companies two to five years after it sent the warning letter.

The GAO wants greater oversight for drug plants in foreign countries, particularly those making medications to be sold in the United States. Until changes are made, the gap between the standards U.S. manufacturers must meet and those that foreign manufacturers are held to will likely remain problematic.

This is the second GAO report this year that has lambasted the FDA for insufficient oversight. Last week, the FDA announced that they will be placing more than 60 regulators in new satellite offices in India, China, Central and South America and the Middle East over the next year.

- read the Associated Press story
- get more at the Wall Street Journal

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