Allan Coukell, director of medical programs at the Pew Health Group, issued a statement concerning a U.S. House energy and commerce subcommittee on health hearing on the reauthorization of the Prescription Drug User Fee Act (PDUFA IV), which has shortened the pharmaceutical approval process by the FDA.
"Many Americans would be surprised by the rapid and profound changes in how our prescription drugs are made and the new risks that have arisen as a result. 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,” said Coukell. “The FDA estimates that 80% of active ingredients used in U.S. drugs come from overseas. Despite the shift of U.S. pharmaceutical manufacturing to overseas, government oversight is overwhelmingly domestically focused.”
Coukell continued, "The reauthorization of the Prescription Drug User Fee Act and passage of other new user-fee programs offer an opportunity for Congress to tackle the risks of the global supply chain. Now it is time for this committee to act on what it has learned over the past four years since the last reauthorization of PDUFA.”
PDUFA IV, which expires Sept. 30, 2012, authorizes the FDA to collect fees from companies that produce certain human drug and biological products.