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 bill 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 drugmakers to reduce risks.
“This is unquestionably the biggest change in the FDA’s regulatory authority in a very long time,” said former FDA Commissioner Mark McClellan. “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 anti-depressants. A tougher version is expected to emerge from the House in coming weeks.
The Senate bill also responds to consumer complaints about misleading drug advertising, by setting up a voluntary program through which the FDA would review television commercials before they are aired.
Following a week of contentious debate and an unsuccessful effort to add a provision allowing consumers to buy drugs from foreign suppliers, the Senate approved the bill 93-1.
Sen. Bernard Sanders, the Vermont independent who is a strong critic of the drug industry, voted no. The import amendment was opposed by the Bush administration and could have stalled the safety overhaul.
The House is expected to soon begin writing its own version of the legislation. Its approach is expected to be tougher on industry, but senior House lawmakers have praised the Senate’s basic approach. Senior members of the House say their main goal is to get a bill to President Bush by the summer.

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