By Robert Pear – Washington Post

WASHINGTON — By a vote of 93 to 1, the Senate passed a bill last Wednesday giving the FDA new power to police drug safety, order changes in drug labels, and restrict the use and distribution of medicines found to pose serious risks to consumers. The bill calls for a fundamental change in the philosophy and operations of the FDA, requiring the agency to focus on the entire life cycle of a drug, including the experience of patients who later take it. Senators said the bill was a response to a loss of confidence in FDAs ability to protect consumers against the dangers of drugs like Vioxx, a popular painkiller withdrawn from the market in 2004.

The Bush administration has not actively opposed the measure and many drug manufacturers support it. The bill is widely seen as “must pass” legislation because it renews authority for the government to collect fees from drug companies to speed the review of their products. “This legislation will make a major difference for families in America, ensuring the safety of our prescription drug system,” said the chief sponsor of the bill, Senator Edward M. Kennedy, Democrat of Massachusetts. “We will also have safer food for families and for pets.”Senator Michael B. Enzi, Republican of Wyoming, said the bill was the “most comprehensive drug safety overhaul in more than a decade.” The no vote was cast by Senator Bernard Sanders, the Vermont independent who is an outspoken critic of the pharmaceutical industry.

The bill sidestepped a multibillion-dollar question: how to give consumers access to lower-cost copies of biotechnology drugs that now cost tens or hundreds of thousands of dollars a year. “If fines are nothing more than the cost of doing business, you cannot deter bad behavior,” said Senator Charles E. Grassley, Republican of Iowa, who proposed the increase. Under the bill, the government would analyze data on tens of millions of patients, looking for signals that particular drugs posed serious risks.

To minimize those risks, the government could order changes in a drug’s label and could require the manufacturer to conduct more studies and clinical trials of a drug already on the market. Under current law, the government and drug companies sometimes haggle for months over changes in drug labeling, and the FDA can request but not compel manufacturers to perform studies.

“For Vioxx, it took 14 months to change the drug’s label to warn doctors and patients of the danger,” Kennedy said. “Companies routinely promise to conduct studies that are never even started, much less completed.” The bill would require the government to establish a public database of all clinical trials and their results. Senator Enzi said the bill could speed the approval of new drugs, by giving the FDA more tools to protect patients after treatments were approved. In exceptional cases, the FDA could restrict the use and distribution of a drug that posed extraordinary risks. The agency could, for example, require special training for doctors who prescribe a particular drug, certification of drugstores that dispense it and monitoring of patients who take it.

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