NCPA - National Center for Policy Analysis


September 30, 2004

After 1962, the Food and Drug Administration (FDA) expanded its regulatory goals from screening all drugs for safety to also determining their degree of effectiveness. Some have expressed concerns that this has unnecessarily slowed the flow of potentially life-saving drugs into the marketplace, the Cato Institute.

A possible solution would be to allow consumers to purchase drugs after they passed the safety test, creating a so called "second track." Meanwhile, the government agency would continue to test how well the drug performs for future users. Dual tracking offers three benefits:

  • New data obtained by consumers who use the second track and from their doctors could supplement the FDA's analyses of clinical trials.
  • The Internet could inform consumers about potentially useful drugs that have not yet undergone the FDA efficacy test.
  • Results experienced by second-track consumers would highlight the costs of time delays stemming from FDA drug approval.

In addition, pharmaceutical firms would have an incentive to keep prices down in order to attract more dual-track consumers. Contracts between developers and consumers would also reduce the avenues through which trial lawyers could sue, which would likely allow for lower prices than otherwise.

Source: Bartley J. Madden, "Breaking the FDA Monopoly," Cato Institute, Summer 2004.

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