Senate approves FDA drug-safety bill

Congress gave final approval Thursday to legislation designed to transform the Food and Drug Administration from a passive monitor to an active detective seeking out medications that have been approved for sale but turn out to be hazardous -- a problem linked to an estimated 15,000 deaths a year.

The drug-safety provisions were the centerpiece of a massive bill that also would renew industry user fees that fund the FDA's review of medications and medical devices submitted for approval.

The Senate passed the bill without objection Thursday evening after the House overwhelmingly passed it Wednesday. The White House has not commented on the final version of the bill, but President Bush is expected to sign it, congressional aides said.

In addition to building a new computerized system to spot drug risks, the bill would strengthen the FDA's enforcement powers and require greater disclosure of private and public clinical research and of agency decision-making. It also would take steps to reduce FDA reliance on outside advisors with financial conflicts of interest, as well as create a new program to review drug company advertising.

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