Pharma, Policy

FDA raises its PDUFA and MDUFA user fees

As it does every year, the FDA has changed its PDUFA and MDUFA fees – and in most cases, it increases.

When new drugs and devices are submitted for approval, the Food and Drug Administration charges a preset user fee to help keep the regulatory process ticking steadily.

The FDA, as it generally does every year, has raised the prices of  PDUFA (Prescription Drug User Fee Act) and MDUFA (Medical Device User Fee Act) applications.

RAPS laid out every price increase –  showing in a table the increases in new drug applications (NDAs), biosimilar applications and every other kind of initial drug review fee. The rates varied from year to year and application to application.

NDAs, for instance, rose this fiscal year 1.7 percent from 2015; but from 2014 to 2015 it rose 7.7 percent. Premarket applications for medical devices, or PMAs, on the other hand increased from the last fiscal year to this one by 4.2 percent, but from the 2014 to 2015 fiscal year it actually went down by 2.9 percent.

You can see the entire list from RAPS here; below is a preview.


As RAPS points out, when drugs were submitted for review in the 1980s, the agencies approval times were slow – thanks to a lack of adequate staff to do the legwork. So in 1992 the PDUFA and, later, PDUFA regulations were put into place to help regulators raise the necessary capital.