Washington, D.C. - U.S. Senator Mike Enzi, R-Wyo., celebrated a monumental victory for Americans who take prescription drugs and all those concerned about food safety, following Senate passage of a bill that will overhaul the way the Food and Drug Administration (FDA) tracks drugs and responds to risks.

The Food and Drug Administration Amendments Act of 2007, H.R. 3580, is headed to President George W. Bush’s desk after two and a half years of bipartisan discussions between Enzi, Senator Edward Kennedy, D-Mass., and leaders in the House of Representatives. The Senate unanimously passed the bill yesterday and the House of Representatives approved the bill by a vote of 405-7 Wednesday.

"Whether medication is for asthma or an ear infection, contraception or cholesterol management, consumers want to know their prescription drugs have been thoroughly tested and are safe. This bill is about allowing those consumers to know the prescription drugs they turn to for help are really going to help them. Imagine a system that gives the Food and Drug Administration, through sound science and remarkable innovation, the tools to get drugs to the market quickly," said Enzi, Ranking Member of the Health, Education, Labor and Pensions (HELP) Committee. "Imagine also a system that gives the FDA new authority to take swift, appropriate, and decisive action to ensure patient safety and protect consumers when new information comes to light to expose unexpected risks. This will be reality."

Following the President’s expected signature, the bill will help the FDA better manage how prescription drugs are approved, tested and monitored for safety, both before and after they find their way into Americans’ medicine cabinets. The bill establishes a system of active surveillance for drugs already on the market and explicitly gives the FDA new authorities to respond quickly and appropriately when previously unknown risks arise. It will also renew important pediatric drug programs that help get therapies approved for children.

"Right now, the FDA has its hands tied behind its back when it tries to manage the risks of drugs already on the market. This bill will clarify and strengthen the FDA’s authority and give it new tools to take measured and appropriate steps to protect the health and safety of Americans when the agency’s post-market surveillance signals potential dangers from a drug or therapy. Pulling a drug from the market and denying patients who need it shouldn’t be the only tool available to the FDA. Now the FDA has more tools in its toolbox to do its job."