FDA reports strong performance in 1998

Pharmaceutical Representative

More than half of all drug approval decisions made by the FDA in 1998 were made on the initial review cycle.

More than half of all drug approval decisions made by the Food and Drug Administration in 1998 were made on the initial review cycle, according to a performance report the agency submitted to Congress in January.

In comparison, only 25% of new drug applications were approved during the initial review cycle in the early 1990s.

The agency attributed this improvement and others to the Prescription Drug User Fee Act, which was first passed in 1992. Fees collected as a result of the legislation permitted the agency to hire more drug reviewers who were then able to process a higher volume of applications without compromising safety or other FDA standards.

In addition to bringing new medicines to patients more quickly, a greater percentage of approvals during the initial review cycle means fewer resubmissions and "suggests that submission quality has improved significantly," the agency stated. In 1996, the FDA received 103 resubmissions; by 1998, that number dropped to 73.

In fact, the number of new product applications submitted last year was slightly lower than that which the FDA has come to expect on an annual basis. Since the Prescription Drug User Fee Act, annual submissions of new product applications had increased from 88 to 130. In 1998, however, the agency saw the first decline in submissions, down from 130 new product applications to 120. Efficacy supplements, which had also been increasing by an average 6% per year, dropped from 162 to 132 in 1998. The number of applications filed and approved "appears to have stabilized," according to the agency.

Countering this trend, however, is an increase in priority applications. Priority applications involve products that represent significant therapeutic gains for consumers and the medical community. "Priority applications accounted for between 20% and 25% of all applications filed each year from fiscal year 1993 to fiscal year 1997," the FDA said. "In fiscal year 1998, they jumped to 32%."

In addition to fewer applications filed, stable approval rates and more priority applications, the agency cited quick and steady approval times as highlights of its performance last year. "The total approval times for applications submitted during the [Prescription Drug User Fee Act] years has leveled at a 12-month median," according to the report. "This is the same median approval time for the fiscal year 1996 submissions and is an improvement over the 16.3-month median of the fiscal year 1995 submissions, the 19- to 20-month medians of the fiscal year 1993 and fiscal year 1994 submissions, and the 23-month median typical of the early 1990s," the agency noted.

Given its steady progress, the agency predicted that first review approvals could speed up to as few as 10 months by 2001 or 2002. PR