NCPA - National Center for Policy Analysis


September 21, 2005

Quicker approval of new drugs by the U.S. Food and Drug Administration (FDA) has not increased the number of prescription drugs withdrawn for safety reasons in this country, according to the Tufts Center for the Study of Drug Development (CSDD).

The Prescription Drug User Fee Act (PDUFA), passed in 1992, authorized the FDA to collect fees from drug companies to be used, in part, to hire additional reviewers and speed the drug review process. PDUFA was reauthorized in 1997 and again in 2002.

Given rising public concern over drug safety and assertions by FDA critics that drug safety in the United States has deteriorated since the adoption of user fees, the CSDD decided to investigate the connection. It found:

  • Of all the drugs approved for sale in the United States in the 1980s, 3.2 percent were subsequently withdrawn; while that rate increased slightly to 3.5 percent during the 1990s, it has since dropped to 1.6 percent.
  • Average time between date of FDA approval and date of subsequent safety withdrawal dropped from 3.7 years in the 1980s to 1.4 years in the 1990s; it the current decade, it has dropped to 0.7 years, but could change if recently approved drugs are later withdrawn.
  • Longer approval times do not assure greater safety; the average time of 2.14 years for drugs withdrawn since 1980 compares to 2.08 years for all approvals during that time; faster approval times also do not correlate with safety withdrawals within therapeutic class.

Researchers failed to establish a link between FDA approval times and drug safety. However, Tufts CSDD Director Kenneth I. Kaitin says many factors influence drug safety, but to date CSDD has found no evidence linking the rate of drug safety withdrawals and the passage of legislation more than a dozen years ago aimed at speeding new drug approvals.

Source: News Release, "No Link Between Drug Safety In U.S. and Approval Speed," Tufts Center for the Study of Drug Development, September 7, 2005.


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