Moderate FDA Reform Pushed

Immediately following the Memorial Day recess, Senate Labor and Human Resources Chairman Jeffords is set to introduce an FDA reform bill that would also reauthorize the Prescription Drug User Fee Act, according to sources.

Staff will begin circulating the legislation today in an effort to attract co-sponsors; the measure will be both introduced and marked up next week.

Many Democrats have cautioned against including the PDUFA reauthorization in a comprehensive FDA reform bill, arguing that the popular user fee law will be held "hostage" if it is part of a contentious FDA modernization effort.

But Republicans, including Jeffords, counter that the PDUFA reauthorization is the "carrot" that will help forge consensus on FDA reform. "It's clear the strongest engine to move FDA reform is legislation that reauthorizes PDUFA," said a committee spokesman.

Under PDUFA, drug manufacturers pay user fees to help cover the costs associated with the government's drug review and approval process.

PDUFA revenues have been credited with speeding up those processes significantly and the law enjoys broad bipartisan and industry support. However, it expires Sept. 30, and FDA officials have warned if Congress fails to reauthorize it, there will be significant disruption and delay in getting new drugs to market.

The Jeffords bill will reauthorize PDUFA for five years and will take a "moderate approach" to FDA modernization, focusing on issues where there is "broad consensus," the spokesman said.