FDA User Fees Have Helped Improve New Drug Review

User fees have allowed the US Food and Drug Administration to exceed congressionally-mandated goals to improve its review of new pharmaceutical preparations, according to the regulatory agency. When user fees were first initiated in 1992, Congress also required that the FDA reviews 55% of New Drug Applications within 12 months by 1994 and 70% by 1996, as well as doing away with a backlog of 700 applications by 1995.

In a report to Congress, FDA Commissioner David Kessler said regulators reviewed 63% of drug applications on time during the fiscal year 1993, and early data indicates even better figures for this year. Additionally, 90% of the backlog has been cleared.

The agency also more than doubled the number of drugs it approved or told companies were approvable pending additional data in fiscal 1993, up from 15% in 1991 and 35% in 1992. User fees forced drug companies to submit better data the first time they file an application, Dr Kessler explained, and the agency has not lowered its standards. User fees also allowed the agency to hire 272 additional regulators. In fiscal 1994, the FDA earned $53 million in user fees.