FDA Hits Sponsors with Higher Drug Development Fees

FDA Imposes Near-15% Increase on Fees for New Drug, Biologics License Applications

Consumers probably aren’t the only ones complaining about the rising cost of prescription drugs—not after the U.S. Food and Drug Administration (FDA) just socked drug study sponsors with hefty price increases effective October 1.

The agency’s FY 2020 fees under the Prescription Drug User Fee Act (PDUFA) are climbing almost 15%.  New drug and biologics license applications requiring clinical data will cost $2,942,965, while applications that need no clinical data will cost $1,471,483. The agency’s annual program fees have been assessed at $325,424.

FY 2019 PDUFA fees were $2,588,478 for applications with clinical data, $1,294,239 for data-less applications, and $309,915 for program fees.

Payment is due for the fees on October 1. Invoices and payment instructions will be sent out by the FDA for FY 2020 program fees this month, the agency said.

The new fee levels will remain in effect through September 30, 2020. For applications that are submitted on or after October 1, 2019, the new fee schedule must be used.

The news isn’t all bad for the drug industry, however. While prescription drug user fees increase, many generic and biosimilar fees are falling under the new pricing scheme, according to an analysis in Pink Sheet from Informa Pharma Intelligence.

By federal law, fee amounts are established each year so that revenues from application fees provide 20% of the total FDA operating revenue, and prescription drug program fees provide 80% of the total revenue.

Author: Michael Causey