Some consumer advocates are out to make outsourced pharmaceutical manufacturing into a potent political issue in Washington. With the PDUFA reauthorization up for debate, Allan Coukell, director of medical programs at the Pew Health Group, told lawmakers that the new, global supply chain for drugs has significantly raised the risk of dangerous or substandard products hitting the market.
"Increased outsourcing and reliance on foreign suppliers have made pharmaceutical manufacturing more difficult to manage and have created opportunities for substandard medicines to reach patients," Coukell told a House subcommittee holding hearings on PDUFA. The group wants the FDA to face the issue head-on as it completes the reauthorization process.
"The FDA estimates that 80 percent of active ingredients used in U.S. drugs come from overseas," Coukell testified, according to remarks issued by the advocacy group. "Despite the shift of U.S. pharmaceutical manufacturing to overseas, government oversight is overwhelmingly domestically focused."
Pew has some close allies in this fight in the rank and file at the FDA. Last spring one FDA official told a meeting at Pew that the agency has been alarmed by the rapid increase in the number of overseas suppliers while the agency has been limited to only a small increase in its inspection force. "The safety of America's food and medical products is under serious challenge," said senior FDA official John Taylor. "Another public health crisis like Heparin," he added, could be just around the corner.
- here's the release from the Pew Health Group