FDA Reform Postponed

Senate floor debate on an FDA reform bill apparently will be postponed until September amid accusations today by Majority Leader Trent Lott, R-Miss., that Senate Labor and Human Resources ranking member Edward Kennedy, D-Mass., is thwarting an agreement on the legislation.

At a briefing with reporters, Lott said Kennedy "continues to hold it up and demand more concessions, which we think are counterproductive." Lott went on to pledge that Republicans will "force that legislation to a vote within the first two weeks" of September.

Negotiations on the legislation have been going on since the legislation was reported by the Senate Labor and Human Resources Committee last month, and the sides claimed last week to have resolved all but one provision pre-empting state laws requiring warnings on non-prescription drugs and cosmetics.

But, according to a source close to the negotiations, Senate Labor and Human Resources Chairman Jeffords, Aging Subcommittee Chairman Judd Gregg, R-N.H., and Children and Families Subcommittee Chairman Dan Coats, R-Ind., Wednesday night presented Kennedy with a "non-negotiable package" of provisions that included previously agreed upon language on four components of the bill as well as the state pre-emption allowance. The changes included pharmacy compounding, legislative history on healtcare economic claims, new device labeling and initial classification of devices. The package also reportedly called for 30 minutes of debate on the bill, equally divided, with no amendments.

A Labor and Human Resources Committee spokesman confirmed that the package of proposed changes "was out there last night." But he added that it was offered in the context of a "back and forth process" and that Jeffords is "still hopeful" that a time agreement can be reached by Friday and the bill taken up before the recess.

Meanwhile -- despite the proposal and Lott's accusations -- a Kennedy aide said Kennedy still believes an "acceptable compromise can be reached on outstanding issues" and he will work to see that "good faith negotiations" on the bill will continue.