Foreign plant inspection lag, FDA fails

MORE REASONS FOR PROBLEMS-FACTS

Mistakes or omissions by the FDA have caused serious physical and mental problems to the public and have even been fatal in many cases. Why is the Food and Drug Admi so inept?

Another reason the FDA is failing is a lack of timely plant inspections. Most domestic firms are inspected every two years according to Rep. John Shimkus® Illinois. As more ingredients come from outside the US the picture is very different. There are 3,200 foreign drug sources according to gov’t auditors. Last year the FDA inspected 30 of these drug sources,less than 1%. At this rate it would take 100 years to inspect the whole 3200. Most of these sources have never been inspected. This fiscal year the FDA plans to inspect 50 foreign sources. At this rate of inspection it would take 60 years to inspect the whole list. This fiscal year about $10 mil has been allocated for foreign inspections.

Rep John L. Barton (R) Texas said ballpark estimates from Republican aides are that the FDA needs 500 more inspectors. The Cov’t Accountability Office said the cost of such by- yearly inspections would be about $70 mil annually. Whatever the actual cost or number of inspectors, we see an agency grossly undermanned and under funded.

.