Biotech Values

[DewDiligence]

PDUFA Bill Clears Congress Despite Temporary Snag In Senate

[A liability “preemption” based on FDA labeling was excluded from the final bill.]

http://www.fdalegislativewatch.com/2007/09/fda-reform-bill.html

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by Cathy Dombrowski
Sept. 21, 2007

The Senate passed the new FDA reform bill, H.R. 3580, by unanimous consent Sept. 20, a day after the House adopted the same measure.

The action staves off worries about FDA sending staff reduction notices. The agency had pushed for action on the bill by Sept. 21. The measure contains the reauthorization of user fees which fund many FDA staff positions and which would otherwise expire Sept. 30.

Swift Senate action was temporarily stymied by a "hold" placed by Sen. Richard Burr, R-N.C., preventing the measure from being brought up for a Senate vote.

Burr reportedly was unhappy with the process by which the bill reached the floor. In order to speed enactment, House and Senate negotiations on a compromise measure were conducted for two months and many differences between the chambers' original bills were resolved - but a formal House/Senate conference was never held.

The result may be a bill that leans toward provisions favored by the House. Among these is language on product liability lawsuits. Burr had inserted a pre-emption provision in the Senate bill that would enable drug companies to defend against such suits by relying on FDA's authority over labeling. This language was dropped from H.R. 3580.
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