PDUFA Provides Americans Access to New Therapies Quickly

The renewal of the Prescription Drug User Fee Act (PDUFA) must provide the Food and Drug Administration (FDA) new tools to better identify and manage safety issues and ensure that Americans never again experience a drug lag in approving revolutionary new therapies.

PDUFA had a tremendous effect on the number of available new therapies, particularly for conditions such as AIDS and cancer.  It effectively ended the drug lag of the 1990s, when foreign countries left us behind in bringing revolutionary therapies into common use.  However, now is not the time to pat ourselves on the back; it is the time to move forward with further improvements.  America is not a “rear view mirror” country.  We are a pedal to the metal country – always optimistic and looking to the future, always looking at how to make things better.

While the PDUFA program has been a success, it can and should be improved to make certain that America maintains its place as the world’s leader in drug safety and innovation and by expanding rapid access to new therapies but still improving safety.

Today’s HELP Committee hearing, “Drug  User Fees: Enhancing Patient Access and Drug safety,