Washington, DC -
01/13/2012 - Allan Coukell, director of medical programs at the Pew Health Group, issued the following statement today, commenting on a package of agreements reauthorizing the U.S. Food and Drug Administration (FDA) user fee programs that fund agency oversight activities, known as the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Act (GDUFA), and Biosimilars User Fee Act (BsUFA):
“We commend the FDA and the pharmaceutical industry for working together on agreements that support the agency’s review activities. Under PDUFA, the FDA has reduced the time it takes to approve new drugs. Now thanks to the first ever agreement with the generic drug makers, industry has made an investment in greater oversight of U.S. medicines made overseas.
“Unfortunately, the Medical Device User Fee Act (MDUFA) is not final. We urge the FDA and the medical device industry not to miss this opportunity to reach an agreement so that the agency will have the resources and tools it needs to protect consumers and ensure that innovative products come to market in a timely fashion.”