FDA inspections of foreign drug facilities could take years
October 27th, 2008 by Jennifer Walker-Journey
This year’s contaminated heparin scare that seriously harmed hundreds of Americans has taught us one thing – we need a better system of ensuring that drugs manufactured in foreign markets are safe for Americans.
The U.S. Food and Drug Administration (FDA) recently announced that it will place more than 60 food and drug regulators worldwide over the next year to inspect foreign drug manufacturing plants.
However, congressional investigators say inspecting the more than 3,000 drug plants in other countries could take as long as 13 years, according to the Associated Press. In comparison, U.S. pharmaceutical factories are inspected by the federal government every 2.7 years on average.
Of the 3,249 foreign facilities for which the FDA has set enforcement priorities, the government agency has only been able to inspect an average of 247 per year, compared to 50 percent of the 3,000 U.S. facilities, according to the Government Accountability Office (GAO).
Inspections of most domestic plants involve ongoing surveillance of facilities’ manufacturing practices. By contrast, foreign facilities are inspected before they are allowed to ship drugs to the U.S. When problems are found at a foreign plant, steps are taken to fix them. However, follow up inspections on those measures by the FDA can take up to five years, the report said.
The GAO report stated significant growth in the foreign drug manufacturing market has presented the FDA with “significant challenges” in ensuring the safety of imported drugs, and urged more surveillance of all foreign drug facilities.