WASHINGTON — The Senate overwhelmingly approved a landmark drug safety bill Wednesday, doubling the number of government scientists assigned to ferret out risky side effects in medicines already on the market.
The measure also would create a computerized network to scan medical insurance and pharmacy records for signs of trouble with new drugs, and significantly expand the Food and Drug Administration's power to require drug makers to reduce risks.
"This is unquestionably the biggest change in the FDA's regulatory authority in a very long time," former agency Commissioner Mark B. McClellan said. "It is really a new era for the FDA that will start after this law is implemented."
The Senate bill was drafted in response to highly 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 U.S. market after being cited in more than 500 deaths. Vioxx was found to increase the risk of heart attacks.
David Willman, a veteran reporter in The Times' Washington Bureau, won a Pulitzer Prize in 2001 for his investigation into FDA approval of seven drugs, including Rezulin. The Times investigation found that the FDA had given the drug fast-track approval despite concerns within the agency over its safety.
The Senate legislation also addresses consumer complaints about misleading drug advertising by setting up a voluntary program through which the FDA would review television commercials before they are aired.
After a week of contentious debate and an unsuccessful effort to add a provision that would allow consumers to buy drugs from foreign suppliers, the Senate approved the bill, 93 to 1. Sen. Bernie Sanders (I-Vt.), a strong critic of the drug industry, cast the "no" vote. The drug importation amendment, opposed by the Bush administration, could have stalled the safety overhaul.
The House is expected to write its own version of the legislation soon. Its approach is likely to be tougher on industry, but senior House lawmakers have praised the Senate's basic approach. They say they hope to get a bill to President Bush by summer.
The safety provisions are part of a larger bill reauthorizing industry user fees that now provide about half the funding for drug review and approval.
