The U.S. House of Representatives voted on Wednesday to reauthorize the Prescription Drug User Fee Act (PDUFA), which would otherwise expire on September 30, 2007.
PDUFA is a law that allows the Food and Drug Administration (FDA) to fund the review of new drugs through fees paid by companies that submit new drug applications. PDUFA was first enacted in 1992 and has been reauthorized twice, in 1997 and 2002.
In the wake of a letter sent to Congress by the Secretary of the Food and Drug Administration (FDA), Dr. Andrew von Eschenbach; Republicans and Democrats in the House came to an agreement early this morning on the highly anticipated reauthorization.
The bill includes the Administration’s request for an increase in the total annual user fees collected to $392.8 million for FY 2008, an $87.4 million increase over the current number.
The legislation also increases the amount of fees devoted to postmarket safety. An additional $225 million in user fees will be collected over five years intended to be used for drug safety activities, supplementing all other drug safety resources.
The reauthorization also contains a “reverse trigger” that states there should be a dollar for dollar reduction in the new user fee for every new dollar appropriated for post market safety.
The legislation will now be voted on in the Senate where if passed will make its way to the desk of the President.
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