By Dr. Alan Goldhammer, Deputy Director for Regulatory Affairs, Pharmaceutical Research Manufacturers of America
The Prescription Drug User Fee Act (PDUFA), first enacted in 1992 and renewed twice since, allows the Food and Drug Administration (FDA) to assess fees from pharmaceutical research companies to help ensure the efficiency of the drug review process.
Over the past 15 years, PDUFA has proven to be a crucial program for FDA and America’s pharmaceutical research companies, but most importantly, for patients. Because of the user fees collected by FDA, the agency has the expanded staff and enhanced technology it needs to perform its essential job.
These additional resources have cut the time it takes FDA to review new drug applications from two-and-a-half years before PDUFA was implemented to 12 months today, meaning that patients have access to potentially life-saving new medicines in less than half the time.
Importantly, the additional resources have enabled FDA to achieve the shortened review times without compromising its stringent standards for evaluating the safety and efficacy of new drugs. In fact, in the last 20 years, only about three percent of medicines have been removed from the U.S. market due to safety issues. What’s more, the new PDUFA bill, per FDA’s recommendations, would allocate nearly $30 million annually over the next five years to further ensure the quality of post-market drug safety surveillance.
The bottom line is that drugs are reaching the people who need them faster, with the assurance of safety that Americans expect from FDA, the world’s preeminent regulatory body for drug review and oversight.
Regardless of the September deadline, Congress should reauthorize PDUFA as soon as possible – with no extraneous provisions.