How to prevent further decline in lifesaving drug approvals

The FDA approved just 22 new medicines last year — the lowest number in six years.

Approval numbers could fall even further if Congress fails to reauthorize the Prescription Drug User Fee Act (PDUFA). By speeding up the approval process, PDUFA helps lower drug prices and save patients' lives.

Congress passed PDUFA in 1992 as a way to hasten the drug approval process. The act allows the FDA to collect millions of dollars in fees from pharmaceutical companies. These fees provide the FDA with the financial resources it needs to swiftly evaluate experimental medicines and determine if they're safe and effective enough for sale. The law must be renewed every five years, and it's up for reauthorization this fall.

If Congress does not reauthorize PDUFA, the FDA will lose an indispensable funding tool. Each year, the FDA collects at least $718 million in user fees — approximately 15 percent of the agency's total budget. These fees have enabled the FDA to hire extra staff, boosting the number of drug reviewers by 77 percent in the first nine years following PDUFA's enactment.

The extra reviewers shortened drug approval times, as intended. Before PDUFA, it took the FDA more than 30 months, on average, to approve a drug. Today, the FDA approves drugs in less than 10 months. Since its enactment, PDUFA has helped the FDA approve more than 1,500 new drugs.