Drug Safety :: Importation Scheme Undermines Intent of Drug Safety Bill

Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Billy Tauzin issued the following statement today regarding the importation amendment attached to the PDUFA reauthorization bill:

?The U.S. Senate will soon vote on the Prescription Drug User Fee Act (PDUFA) reauthorization bill so that the Food and Drug Administration can have the resources it needs to fulfill its mission to protect the public health. PhRMA is concerned, however, that the attached importation provision could jeopardize patient safety. The importation of potentially dangerous and counterfeit medicines from foreign countries would threaten the health of American patients who rely on safe and effective medicines to help them win their battle against disease.

?Since its original enactment in 1992, PDUFA has been a resounding success for the FDA, pharmaceutical research companies, taxpayers and, most importantly, patients. The resources and additional staffing made possible by the fees charged by the FDA have enabled the agency to review new medicines more efficiently, while maintaining its stringent safety and efficacy standards.

?In general, the PDUFA legislation in the Senate, absent any importation language, will preserve ? and even strengthen ? the FDA’s ability to do its job. Patients will continue to have timely access to innovative therapies, and they can be assured that the medicines they receive are reviewed under the most rigorous safety and efficacy standards in the world today.

?What alarms PhRMA, however, is the fact that the importation provision undermines the intent of PDUFA and FDA ‘s efforts to protect patient health. Simply put, the importation of medicines from foreign countries, in our view, is equivalent to importing into America the soaring epidemic of dangerous counterfeits around the world. According to the Center for Medicine in the Public Interest, counterfeit drug sales could reach $75 billion in 2010, a 92 percent increase from 2005. Recent articles by The New York Times ? including yesterday?s article highlighting the deadly epidemic of counterfeit drugs in foreign countries that has resulted in patient deaths ? have also caused great concern about the dangers importation schemes could pose.

?In the interest of patient safety and health, we ask that Congress reconsider the inclusion of importation in any final PDUFA reauthorization bill.”