Pew director issues statement on Prescription Drug User Fee Act hearing

Allan Coukell, director of medical programs for the Pew Health Group, issued the following statement today on a U.S. Senate Health, Education, Labor & Pensions Committee hearing, "FDA User Fees: Advancing Public Health."

"We applaud the Senate Health, Education, Labor & Pensions Committee for holding a hearing on the Prescription Drug User Fee Act (PDUFA V). This forum will be a chance to learn about the need for a contemporary regulatory system that will match today's pharmaceutical marketplace."

"The reauthorization of the Prescription Drug User Fee Act (PDUFA V) in the past has been an opportunity to address the risks of unsafe drugs. The 2012 bill should follow in this tradition."

"As pharmaceutical manufacturing is increasingly globalized and outsourced, Congress must close serious gaps in FDA oversight. In particular, the agency must be able to order the recall of adulterated drugs -- a power now lacking -- and must have the ability to block medicines from entering the U.S. if they were made at a factory that refused an FDA inspection. At the same time, manufacturers should bear ultimate responsibility for drug safety. Congress should require companies purchasing pharmaceutical ingredients from overseas to ensure that their suppliers are manufacturing to the highest standards."