Final US PDUFA recommendations go to Congress; "will boost drug review safety"

The US Food and Drug Administration recently submitted to Congress its final proposal for reauthorizing the Prescription Drug User Fee Act (PDUFA IV) after reviewing public comments.

The PDUFA, which was first enacted in 1992 and has been reauthorized twice, provides user fee funds, paid by brand-name drug and biotechnology companies that are added to appropriated funds to support the review of new human medicines. Since 1992, the FDA has provided the public with 1,220 new drugs and biologics. The current user fee program is scheduled to expire on September 30 this year.

"The reauthorization of this law plays a significant role in [the] FDA's continued ability to make drug therapies available to the American public in a timely fashion without sacrificing the quality of approval decisions," said Andrew von Eschenbach, the aency's Commissioner, adding: "our proposed recommendations for PDUFA IV aim to strengthen our drug safety system and upgrade ogy capability."