The US Senate has overwhelmingly passed legislation that will provide the Food and Drug Administration sweeping powers to supervise and regulate drug safety, order changes in drug labels, regulate advertising and restrict the use and distribution of medicines found to pose serious threats to consumers. The bill calls for a vital transformation in the philosophy and operations of the FDA, requiring the agency to concentrate on the entire life cycle of a drug, not just the years prior to its approval, but also the experience of patients who later consume it. The latest legislation would change how drugs are regulated in the US completely, giving the Food and Drug Administration new powers to restrict medications that raise serious safety concerns. The Senate bill was drafted in response to much publicized safety lapses, including the belated withdrawals of the painkiller Vioxx and the diabetes drug Rezulin, as well as the FDA’s tardy warning about the suicide risks of antidepressants. Rezulin, which was found to cause liver failure, was pulled from the US market after being referred in more than 500 deaths. At the same time, Vioxx was found to increase the risks of heart attacks. The latest move will envisage establishing a computerized network to scrutinize medical insurance and pharmacy records for signs of trouble with new drugs, and significantly expand the FDA’s power to require drug makers to reduce risks. The Senate legislation also addresses consumer complaints about confusing drug advertising by setting up a voluntary program through which the FDA would examine television commercials before they are aired. The proposed legislation is also facing criticism from some consumer groups and lawmakers as they oppose using industry fees to fund the FDA, on the ground that it creates a conflict of interest. However, the legislation is considered must-pass since if Congress fails to act by summer, the FDA could be compelled to notify hundreds of senior scientists, doctors and statisticians, whose skills are in demand in private industry, that their jobs might be at risk. Under the prevailing system, new drugs are tested on no more than a few thousand people before approval, and rare side effects might not emerge until many more patients have used a medication. Some prominent medical analysts are of the view that all drugs should be considered experimental for at least two or three years after approval. On the other hand, the Bush administration has not out rightly opposed the measure, though it says the agency already has all the regulatory authority it needs. But, the agency officials have been divided over whether they have the enough power. In the meanwhile, drug company executives have succeeded in their efforts to impede a provision of the bill that would have legalized imports of lower-priced medicines from Canada.