Regulatory News

FDA Unveils User Fee Rates for FY2016

In the 1980s, the US lagged behind Europe in drug approvals, and individual drug reviews often took years to complete. These lengthy approval times were a significant source of frustration not only for patients and drug companies, but for FDA itself.

The problem, FDA argued, was that the agency lacked adequate funding to hire the staff it needed to review drugs in a more timely manner. The solution FDA proposed was to collect one-time fees from the companies it regulates for each new drug approval, which would provide the agency with a substantial source of funding to boost its staff and reduce review times.

Eventually, this led to the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, which authorized FDA to collect fees for its review activities in return for a speedier, more predictable review process.

Since then, Congress has enacted many other user fee acts covering medical devices, generic drugs, animal drugs and biosimilars, as well as related inspection and registration activities.

FY2016 Fees

Each year, FDA adjusts the rates of these fees to keep up with inflation and the agency's workload. The table below shows the rates to be charged for FY2016, which take effect on 1 October 2015.