NCPA - National Center for Policy Analysis

FDA Drug Approvals Dropping

April 20, 1999

After the Food and Drug Administration streamlined its drug approval process beginning in 1993, approvals more than doubled by 1996 -- as the time for final review of new drugs was cut to 15 months, from 30 months. But last year, approvals plummeted to near their former levels.

Part of the problem, observers report, is an almost constant exodus of experienced staffers among the agency's 8,900 employees.

  • In 1996, the agency approved 53 new drugs -- but only 30 last year.
  • Nearly 25 years ago, the FDA launched Operation Hire -- an initiative that expanded the agency by hundreds of employees.
  • As a result, 70 percent of all managers will be eligible for retirement in the next two years.
  • Morale at the agency is reportedly so low that many employees are packing their bags -- including 12 out of 22 statisticians in a department which analyzes 70 percent of all drugs approved.

In 1993, the pharmaceuticals industry stepped in and offered millions of dollars to assist in the effort to speed up drug approvals. While some staffers contend this could compromise the approval process, others report that the extra money only served to improve efficiency.

Source: Rochelle Sharpe, "FDA Tries to Find Right Balance on Drug Approvals," Wall Street Journal, April 20, 1999.


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