Lott Moves to Force FDA Reform

Lott Moves to Force FDA Reform

Senate Majority Leader Lott, frustrated by the stumbling negotiations over a measure he has rated as a top priority for this fall, Wednesday night filed a cloture motion on the languishing bill to renew the expiring prescription drug user fee program and otherwise overhaul operations at the Food and Drug Administration.

Negotiations continue to drag on over several issues central to the legislation.

The Senate will vote on cloture Friday, and Lott told reporters earlier in the day he expected to bring the bill up either that day or early next week.

Lott had been trying to bring the FDA bill to the floor for much of the two weeks before the August recess.

But the majority leader was stymied as Sen. Edward Kennedy, D- Mass., ranking member of the Labor and Human Resources Committee, and a handful of other Democratic senators continued to raise problems with the legislation on behalf of consumer and public health advocacy groups.

The measure is time sensitive, it carries within it reauthorization of the popular program that has speeded up the FDA's approval of prescription drugs by charging their manufacturers user fees.

The prescription drug user fee program will otherwise expire at the end of September.

Although several issues have been worked out on the measure, a spokesman for Senate Labor and Human Resources Chairman Jeffords, the bill's sponsor, said more than three dozen changes have been made since the committee approved it to try to accommodate concerns raised, several more remain.

Among the thorniest is whether to preempt state laws regulating cosmetics and over-the-counter drugs.

Negotiators have reportedly agreed to grandfather California's cosmetic labeling law passed as a voter initiative, but whether other states would be able to pass new laws in the future remains in dispute.

Also still open are two issues related to the medical device industry, whether the FDA can review all potential device uses or merely the use specified by the manufacturer, and whether the agency can review manufacturing practices as well as the device itself.

Earlier in the day, Lott said he was frustrated by the slow- pace of the negotiations.

"I don't think they're focused," he said of senators who are trying to work through the problems.

Filing cloture, Lott said, "is one way to get them to focus."

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