So many of the drugs approved in the U.S. are manufactured overseas that the FDA is having a hard time keeping up with inspections in the supply chain. The result could be another tainted-drug disaster just waiting to happen. This is not an FDA watchdog with an agenda sounding the alarm; the agency itself came out with the dire warning.
"The safety of America's food and medical products is under serious challenge," warned senior FDA official John Taylor, who was speaking at a Pew Health Group meeting. He raised the specter of "another public health crisis like Heparin." In 2008, contaminants in the blood thinner Heparin produced in China led to more than 100 deaths in the U.S.
Pharmalot's Ed Silverman puts the problem in perspective. The number of foreign manufacturing plants grew to more than 3,500 in 2008--up from roughly 1,200 in 2001, he writes. That's a 185 percent increase. Yet the number of FDA inspections rose 23 percent, leading to a 57 percent drop in the inspection rate.
Some of the solutions the FDA has mentioned include more partnering with foreign counterparts and hiring of private inspectors.