PDUFA Turns Two


Since it was initially passed more than two decades ago, the Prescription Drug User Fee Act has consistently strived to ensure that Americans have timely access to the new safe and effective medicines they need. Two years ago this month, President Obama signed the fifth version of the Act (PDUFA V) into law.

In celebration of PDUFA's second birthday, take a look at the progress the FDA has made towards PDUFA goals in the last two years:

  • PDUFA has helped make the FDA's review of new medicines more predictable and consistent. This not only increases patient access to safe and effective treatments; it encourages companies to invest in innovation, keeping the United States the global leader in discovering and developing new treatments.
  • In order to gain further insight into the day-to-day realities of living with a medical condition, the FDA has been holding Patient-Focused Drug Development (PFDD) meetings and gathering feedback from patients themselves. The FDA plans to hold nine more meetings in the coming year.
  • The introduction of the breakthrough therapy designation has accelerated approvals for some treatments targeted for serious or life-threatening conditions. This newer designation is ensuring that patients with unmet medical needs have faster access to medicines that could literally be life savers.

PDUFA V has come a long way, but there's still a significant portion left to implement. To learn more about what's in store for PDUFA in the next three years take a look at our interactive PDUFA timeline: