UNIT 1 Legislation Of Drugs Flashcards
(17 cards)
Prohibited mislabeling and adulteration of drugs.
Pure Food and Drug Act of 1906
Prohibited importation of opium.
Opium Exclusion Act of 1909
Prohibited false or fraudulent advertising claims.
Amendment (1912) to the Pure Food and Drug Act
Established regulations for use of opium, opiates, and cocaine (marijuana added in 1937).
Harrison Narcotic Act of 1914
Required that new drugs be safe as well as pure (but did not require proof of efficacy). Enforcement by FDA.
Food, Drug, and Cosmetic Act of 1938
Vested in the FDA the power to determine which products could be sold without prescription.
Durham-Humphrey Act of 1952
Required proof of efficacy as well as safety for new drugs and for drugs released since 1938; established guidelines for reporting of information about adverse reactions, clinical testing, and advertising of new drugs.
Kefauver-Harris Amendments (1962) to the Food, Drug, and Cosmetic Act
Outlined strict controls in the manufacture, distribution, and prescribing of habit-forming drugs; established drug schedules and programs to prevent and treat drug addiction.
Comprehensive Drug Abuse Prevention and Control Act (1970)
Provided incentives for development of drugs that treat diseases with fewer than 200,000 patients in USA.
Orphan Drug Amendment of 1983
Abbreviated new drug applications for generic drugs. Required bioequivalence data. Patent life extended by amount of time drug delayed by FDA review process. Cannot exceed 5 extra years or extend to more than 14 years post-NDA approval.
Drug Price Competition and Patent Restoration Act of 1984
Manufacturers pay user fees for certain new drug applications. “Breakthrough” products may receive special category approval after expanded phase 1 trials (2012).
Prescription Drug User Fee Act (1992, reauthorized 2007, 2012)
Established standards with respect to dietary supplements but prohibited full FDA review of supplements and botanicals as drugs. Required the establishment of specific ingredient and nutrition information labeling that defines dietary supplements and classifies them as part of the food supply but allows unregulated advertising.
Dietary Supplement Health and Education Act (1994)
Enhanced controls on dangerous biologic agents and toxins. Seeks to protect safety of food, water, and drug supply.
Bioterrorism Act of 2002
Granted FDA greater authority over drug marketing, labeling, and direct-to-consumer advertising; required post-approval studies, established active surveillance systems, made clinical trial operations and results more visible to the public.
Food and Drug Administration Amendments Act of 2007
Authorized the FDA to establish a program of abbreviated pathways for approval of “biosimilar” biologics (generic versions of monoclonal antibodies, etc).
Biologics Price Competition and Innovation Act of 2009
Renewed FDA authorization for accelerated approval of urgently needed drugs; established new acceleratedprocess,“breakthroughtherapy,”inadditionto“priorityreview,”“acceleratedapproval,”and “fast-track” procedures.
FDA Safety and Innovation Act of 2012
