NCPA - National Center for Policy Analysis

Regulators are Taking Longer to Approve Some Drugs

January 29, 2002

The Food and Drug Administration has dramatically increased the pace of drug approvals since the early 1990s. But the pharmaceutical industry is now charging that approval times for certain categories of drugs are once again on the increase.

The FDA divides drugs into "standard" and "priority." Priority applications involve important new drugs that the agency tries to evaluate within six months.

  • The median review time for priority drugs has fallen from 20.5 months in 1993 to six months in 2001.
  • For standard applications, times improved from 26.9 months in 1993 to 12 months in 2000 -- before jumping back up to 14 months last year.
  • So-called "new molecular entities" -- which are an important subset of standard applications and represent breakthrough products -- hit a low of 13.4 months for approvals in 1998, before climbing to 19 months in 2001.

A 1992 law that prodded the FDA to speed up the pace of approvals in exchange for fees paid by the industry is up for review. After user fees kicked in during the early 1990s, the FDA substantially beefed up its reviewing staff and the pace of approvals quickened.

The law will expire this fall, but the chances for renewal are considered good.

Source: Chris Adams and Scott Hensley, "Drug Makers See FDA Approval Slowdown," Wall Street Journal, January 29, 2001.


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