HMGT 3310 - Final Exam (chapters 5-8, ACA) Latest Update!!
Common Rule - name used for the Federal Policy for the
Protection of Human Subjects
issues related to drug/health product regulation - Answer - safety and efficacy
- oversight pre and post market
- intellectual property rights
- access to medication
history of regulations - Answer Imports Drug Act of 1848 --> formation of USDA Bureau
of Chemistry in 1862 --> Biologics Control Act of 1902 --> Pure Food and Drug Act of
1906 --> Shirley Amendment of 1912 --> Harrison Narcotics Tax Act of 1914 --> FDA
formation in 1930 --> Food, Drug, and Cosmetic Act of 1938 --> Wheeler-Lea Act -->
Required PTO Filing in 1962
Imports Drug Act (1848) - Answer - restrict importation of foreign drugs
- adulterated/adulterated drugs: inspections/destruction/detention/exportation of
substandard drugs
USDA Bureau of Chemistry (1862) - Answer - inquiry into the safety of food, drugs, and
animal feed at the federal level
Biologics Control Act (1902) - Answer - due to faulty production of diphtheria vaccine,
first federal law to regulate a pharmaceutical product
- licensing procedures established for the manufacture and distribution of vaccines
- allowed government officials to inspect laboratories and factories
Pure Food and Drug Act (1906) - Answer - in reaction to Upton Sinclair's novel "The
,Jungle" depicting unsafe and unsanitary conditions in the meat packing industry
- broad proscription against "adulteration and misbranding of foods and drugs in
interstate commerce
Shirley Amendment (1912) - Answer - outlawed false therapeutic claims that were
deliberately designed to deceive the consumer
Harrison Narcotics Tax Act (1914) - required prescriptions before patients could obtain
products containing more than minimal amounts of narcotic substances
- required physicians and pharmacists to maintain records of prescriptions issued and
dispensed
FDA formation (1930) - set standards for packaging of most canned foods
Food, Drug, and Cosmetic Act (1938) - response to toxic antibiotics that killed 107
children
- established the basic regulatory structure that controls pharmaceuticals today
- procedures for review of the safety of new drugs before they came to market
- extension of the FDA's scope of authority to include cosmetics and therapeutic devices
- elimination of the requirement that the government prove fraud to prosecute false
claims
- new authority for the FDA to inspect factories and to obtain court injunctions against
the distribution of unsafe or adulterated products
- expansion of FDA standard-setting authority for quality and packaging of food
Wheeler-Lea Act - Answer - authorized the Federal Trade Commission (FTC) to regulate
advertising of products subject to FDA oversight other than prescription drugs
Mandated PTO Filings 1962 - Answer - Kefauver-Harris Amendments: response to
thalidomide babies, shift from safety to efficacy, retroactive review of 24 years, rejected
FDA 60 day review requirement
, FDA amendments - Answer - Durham-Humphrey 1951: over the counter v. prescription
regulations
- Factory Inspection 1953: FDA inspection reports must be provided to manufacturers
- Miller Pesticide 1954: limits on pesticides on raw foods
- Food Additives 1958: carcinogens
Food, Drug, Cosmetic Act Additives - Color Additives 1960 colors that are carcinogens
prohibited Saccharin restriction 1969, reinstatement 1977, no requirement of notice
1996 Food Quality Protection 1996 pesticides
FDA supplements Answer EPA 1970 pesticides FDA 1971 addition of radiological
exposure responsibility NIH --> FDA 1972 all vaccine, blood products and other biologic
oversight FDA --> CPSC 1973 oversight of toys and other consumer products FDA 1976
medical devices
steps + 3 phases of drug review in humans - Answer - PTO filing for exclusive rights +
evaluation of safety and efficacy (IND exemption) + animal testing (31 months)
1. Phase I: small group, healthy volunteers (20 months)
2. Phase II: small group with targeted health condition (30 months)
3. Phase III: large subject test in clinical practice setting (31 months)
- file NDA
- advisory committee review + make recommendations
- finally: FDA approval
Hatch-Waxman Act of 1984 - Answer - 20 year patents (legal monopoly; forbids market
competition on temporary basis to protect profit potential)
- generics: treated as new drugs for FDA approval process --> increased generic market
share and bypassing of phases I & II
- Orange Book = list of all patents related to their approved drugs with the FDA.
- increased competition, which lowered costs
- trials of active ingredient already undergone --> reduces safety concern
Common Rule - name used for the Federal Policy for the
Protection of Human Subjects
issues related to drug/health product regulation - Answer - safety and efficacy
- oversight pre and post market
- intellectual property rights
- access to medication
history of regulations - Answer Imports Drug Act of 1848 --> formation of USDA Bureau
of Chemistry in 1862 --> Biologics Control Act of 1902 --> Pure Food and Drug Act of
1906 --> Shirley Amendment of 1912 --> Harrison Narcotics Tax Act of 1914 --> FDA
formation in 1930 --> Food, Drug, and Cosmetic Act of 1938 --> Wheeler-Lea Act -->
Required PTO Filing in 1962
Imports Drug Act (1848) - Answer - restrict importation of foreign drugs
- adulterated/adulterated drugs: inspections/destruction/detention/exportation of
substandard drugs
USDA Bureau of Chemistry (1862) - Answer - inquiry into the safety of food, drugs, and
animal feed at the federal level
Biologics Control Act (1902) - Answer - due to faulty production of diphtheria vaccine,
first federal law to regulate a pharmaceutical product
- licensing procedures established for the manufacture and distribution of vaccines
- allowed government officials to inspect laboratories and factories
Pure Food and Drug Act (1906) - Answer - in reaction to Upton Sinclair's novel "The
,Jungle" depicting unsafe and unsanitary conditions in the meat packing industry
- broad proscription against "adulteration and misbranding of foods and drugs in
interstate commerce
Shirley Amendment (1912) - Answer - outlawed false therapeutic claims that were
deliberately designed to deceive the consumer
Harrison Narcotics Tax Act (1914) - required prescriptions before patients could obtain
products containing more than minimal amounts of narcotic substances
- required physicians and pharmacists to maintain records of prescriptions issued and
dispensed
FDA formation (1930) - set standards for packaging of most canned foods
Food, Drug, and Cosmetic Act (1938) - response to toxic antibiotics that killed 107
children
- established the basic regulatory structure that controls pharmaceuticals today
- procedures for review of the safety of new drugs before they came to market
- extension of the FDA's scope of authority to include cosmetics and therapeutic devices
- elimination of the requirement that the government prove fraud to prosecute false
claims
- new authority for the FDA to inspect factories and to obtain court injunctions against
the distribution of unsafe or adulterated products
- expansion of FDA standard-setting authority for quality and packaging of food
Wheeler-Lea Act - Answer - authorized the Federal Trade Commission (FTC) to regulate
advertising of products subject to FDA oversight other than prescription drugs
Mandated PTO Filings 1962 - Answer - Kefauver-Harris Amendments: response to
thalidomide babies, shift from safety to efficacy, retroactive review of 24 years, rejected
FDA 60 day review requirement
, FDA amendments - Answer - Durham-Humphrey 1951: over the counter v. prescription
regulations
- Factory Inspection 1953: FDA inspection reports must be provided to manufacturers
- Miller Pesticide 1954: limits on pesticides on raw foods
- Food Additives 1958: carcinogens
Food, Drug, Cosmetic Act Additives - Color Additives 1960 colors that are carcinogens
prohibited Saccharin restriction 1969, reinstatement 1977, no requirement of notice
1996 Food Quality Protection 1996 pesticides
FDA supplements Answer EPA 1970 pesticides FDA 1971 addition of radiological
exposure responsibility NIH --> FDA 1972 all vaccine, blood products and other biologic
oversight FDA --> CPSC 1973 oversight of toys and other consumer products FDA 1976
medical devices
steps + 3 phases of drug review in humans - Answer - PTO filing for exclusive rights +
evaluation of safety and efficacy (IND exemption) + animal testing (31 months)
1. Phase I: small group, healthy volunteers (20 months)
2. Phase II: small group with targeted health condition (30 months)
3. Phase III: large subject test in clinical practice setting (31 months)
- file NDA
- advisory committee review + make recommendations
- finally: FDA approval
Hatch-Waxman Act of 1984 - Answer - 20 year patents (legal monopoly; forbids market
competition on temporary basis to protect profit potential)
- generics: treated as new drugs for FDA approval process --> increased generic market
share and bypassing of phases I & II
- Orange Book = list of all patents related to their approved drugs with the FDA.
- increased competition, which lowered costs
- trials of active ingredient already undergone --> reduces safety concern
