On the recordSeptember 20, 2007
Today, the Senate will send a bipartisan bill to the President that will improve the FDA's ability to assure the safety of drugs in our medicine cabinets and the food in our kitchens. The FDA is an essential guardian of the public's health and safety. In recent years, FDA's reputation has been marred by drug safety incidents and questions about its scientific independence. In 2004, the public learned that taking Vioxx, a heavily marketed pain medication, increased your risk of a heart attack and stroke. The revelation raised serious questions about how the drug manufacturer responded to signs of a problem and how FDA handled disagreements among its staff. The Vioxx episode and problems with other FDA-approved drugs in recent years exposed significant weaknesses in our Nation's drug-safety system. This year, Congress decided to do something about it. In addition to reauthorizing user fee programs for prescription drugs and medical devices, we have engaged in a serious effort to improve drug safety. The bill gives the FDA more tools to detect the safety problems of drugs after they are available to consumers. It also creates an active surveillance system that will help detect problems that were not apparent during the clinical trials conducted prior to a drug's approval and it promotes greater openness by requiring disclosure of clinical trials performed by drug companies.
Source
govinfo.gov




