WASHINGTON -- The Senate overwhelmingly approved a landmark drug safety bill yesterday, doubling the number of government scientists assigned to ferret out risky side effects in medicines on the market.
It would create a computerized network to scan medical insurance and pharmacy records for signs of trouble with new drugs and would 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.
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. A tougher version is expected to emerge from the House.
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.
After 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 begin writing its own version of the legislation soon. 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.
The safety provisions are part of a larger bill reauthorizing industry user fees that provide about half the funding for drug review and approval. Some consumer groups and lawmakers oppose funding the FDA through industry fees, saying it creates a conflict of interest.
The funding legislation is considered "must-pass" because, if Congress does not act by the summer, the FDA could be forced to notify hundreds of senior scientists, doctors and statisticians - whose skills are in demand in private industry - that their jobs could be at risk.
Drafted by Sens. Edward M. Kennedy, a Massachusetts Democrat, and Michael B. Enzi, a Wyoming Republican, the Senate bill would more than double the FDA's safety office from its current staff of about 90. The cost of expansion would be covered by user fees, which would rise from more than $300 million this year to $539 million in 2008 and $916 million in 2012, according to Senate staff.
Ricardo Alonso-Zaldivar writes for the Los Angeles Times.