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p61.GIF (21964 bytes) The Prescription Drug User Fee Act, passed in 1992, required drug and biologic manufacturers to pay fees to the FDA for the evaluation of NDAs and supplements. Also, the firms would pay an annual establishment fee and product fees. Congress required FDA to apply user fees to hire more reviewers, and thus expedite the reviews. Following the passage of this legislation, the number of new drug approvals has indeed increased steadily each year, from 63 in 1991 to a record 131 in 1996. Also, median approval times for new molecular entities and for all NDAs have been cut in half from 1993 to 1998 from about two years to twelve months for both categories.
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