History of Drug Regulation in the USA.txt

Card Set Information

History of Drug Regulation in the USA.txt
2012-09-08 23:11:54
Drug Regulation

History of Drug Regulation in the USA.txt
Show Answers:

  1. 1. First United States Pharmacopeia (USP) in USP
  2. 2. Import Drug Act of 1848
    (Story: Due to US Mexican War)

    It mandated inspection prior to admission to the country
  3. 3. The Bureau of Chemistry founded (1862)
  4. 4. Upton Sinclair wrote about unsanitary conditions (1901)
  5. 5. Biologics Control Act (1902)
    (Story: deaths of children caused by contaminated vaccines)

    Safety, purify, and effectiveness of biological products

    (Led to formation of CBER, a predecessor of the FDA)
  6. 6. Pure Food and Drugs Act (1906)
    Prohibit interstate commerce of misbranded and adulterated food, drinks, drugs. Precursor to FDA formation.
  7. 7. Sherley Amendment (1912)
    Prohibit false therapeutic claims
  8. 8. FDA was formed (1930)
  9. 9. Federal Food, Drug, and Cosmetic Act (1938)
    (Story: deaths due to diethylene glycol was used to dissolve sulfanilamide meds to make a liquid form)

    Required animal tests. Law has been amended many times.
  10. 10. Durham-Humphrey Amendment to the Act of 1938 (1951)
    "Prescription Amendment". Differentiate between OTC and prescription drugs. PHoen prescription and refill.
  11. 11. Kefauver-Harris Amendment (1962)
    • (Story: Thalidomide disaster)
    • Need to prove effectiveness to FDA before marketing a drug.
  12. 12. Drug Listing Act (1972)
    Give FDA a list of all their drugs by NDC, a unique product identifier.
  13. 13. Orphan Drug Act (1983)
    Designed to facilitate the development and commercialization of drugs to treat rare disease.
  14. 14. Drug Price Competition and Patent Restoration Act (1984)
    Provides for a period fo exclusivity such that once a New Molecular Entity (NME) is approved, a generic version cannot be approved for 5 years.
  15. 15. Revision of New Drug Application (NDA) regulations (1985)
    These changes provide for safety reports after an application for a new drug is submitted, more focused and better organized data, use fo summaries and tables for easier review, etc
  16. 16. Drug Exports Amendments (1986)
    Can export meds to other countries even if it's not approved by the FDA.
  17. 17. Prescription Drug Marketing Act (1987)
    Prevent illegal diversion and sale of prescription drugs from legitmate distributors.
  18. 18. Revision of Investigational New Drug (IND) Regulations (1987)
  19. 19. Treatment use of INDs (Investigational New Drug) (1987)
    Made promising new drugs available to desperately ill patients as early in the drug development process as possible.
  20. 20. Generic Drug Enforcement Act (1992)
  21. 21. Prescription Drug User Free Act (PDUFA) (1992)