The Hill News

In order for a new drug to become widely available in this country, it must first gain approval by the U.S. Food and Drug Administration (FDA).  Two decades ago the FDA suffered from a severe backlog of new drug applications, which was obstructing countless potentially lifesaving medicines from reaching patients.   To address this crisis, Congress passed the Prescription Drug User Fee Act (PDUFA).  And this week, FDA held its Public Meeting on the reauthorization of PDUFA V, which needs to be reauthorized before October 2012.

Since its enactment the user fees helped alleviate that backlog, provide vital resources to the FDA, and altered the course of new product availability.  Today, new cancer medicines average an approval time of six months, compared to 15 months before PDUFA was enacted.   And new cancer medicines are now approved significantly sooner in the U.S. compared to Europe.

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