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Related Experiment Videos

A proposal for FDA reform.

Henry I Miller1

  • 1Hoover Institution, Stanford University, Stanford, California 94305-6010, USA. miller@hoover.stanford.edu

Nature Reviews. Drug Discovery
|October 31, 2002
PubMed
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This summary is machine-generated.

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The US drug regulation system, established in 1962, has increasingly burdened drug developers with higher costs and longer timelines. Fundamental legislative reform is needed to address these escalating challenges.

Area of Science:

  • Pharmacoeconomics
  • Regulatory Science
  • Health Policy

Background:

  • The current framework for US drug regulation was established in 1962.
  • Since its inception, the Food and Drug Administration (FDA) has expanded its regulatory responsibilities.
  • This expansion has led to a significant increase in the regulatory burden for drug developers.

Approach:

  • Analysis of the historical evolution of FDA regulatory scope.
  • Assessment of the impact of regulatory expansion on drug development costs and timelines.
  • Evaluation of the necessity for fundamental reform in drug regulation.

Key Points:

  • Drug development costs and timelines have escalated due to increased regulatory demands.
  • The existing regulatory system faces challenges in efficiency and adaptability.

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  • The current regulatory framework may impede timely access to novel therapeutics.

    • Conclusions:

    • The current drug regulatory system requires substantial reform.
    • Reform must be fundamental, addressing systemic issues rather than incremental adjustments.
    • External legislative action, rather than internal agency changes, is proposed as the necessary catalyst for reform.