Legislation

Key Legislation Timeline

  • 1906 - Pure Food and Drug Act

    • Established standards for drug labeling.

    • Forerunner of the FDA.

  • 1912 - Shirley Amendment

    • Prohibited fraudulent drug effectiveness claims.

  • 1914 - Harrison Narcotic Act

    • Restricted narcotics: opium, cocaine, marijuana.

  • 1938 - Food Drug and Cosmetic Act

    • Expanded FDA powers; required drug safety proof.

    • Authorized factory inspections and penalties for fraud.

  • 1945 - Amendment

    • Required certification for biologics like insulin.

  • 1951 - Durham-Humphrey Amendment

    • Differentiated prescription drugs from over-the-counter drugs.

  • 1962 - Kefauver-Harris Amendment

    • Required evidence of drug effectiveness from clinical studies.

  • 1970 - Comprehensive Drug Abuse Prevention and Control Act

    • Regulated narcotics; categorized drugs by abuse potential.

  • 1978 - Drug Regulation Reform Act

    • Established research guidelines and expedited drug marketing.

  • 1983 - Orphan Drug Act

    • Provided incentives for rare disease drug development.

  • 1987 - Amendment

    • Speeded up approval for high-priority medications.

  • 1992 - Prescription Drug User Fee Act

    • Allowed FDA to charge fees to expedite drug reviews.

  • 1993 - NIH Revitalization Act

    • Mandated inclusion of women/minorities in NIH studies.

  • 1997 - FDA Modernization Act

    • Updated biologic product regulations; enhanced patient access to experimental drugs.

  • 2002 - Best Pharmaceuticals for Children Act

    • Encouraged pediatric studies and labeling of drugs for children.

  • 2003 - Medicare Prescription Drug Improvement and Modernization Act

    • Major overhaul of Medicare; introduced prescription drug benefits.

  • 2005 - Combat Methamphetamine Epidemic Act

    • Regulated sales of key ingredients in illegal drugs.

  • 2008 - Ryan Haight Online Pharmacy Consumer Protection Act

    • Regulated internet sales of controlled substances.

  • 2018 - SUPPORT for Patients and Communities Act

    • Focused resources on opioid crisis management and expanded treatment options.