Chapter 1: Issues for the Practitioner in
Drug Therapy
Office visit drug spending - ANS -$ 2.6 billion
Inpatient admissions drug spending - ANS -$329 million
emergency department visits drug spending - ANS -$ 286 million
Pure Food and Drug Act of 1906 - ANS -Prohibited mislabeling and adulteration of drugs
Opium Exclusion Act of 1909 - ANS -prohibited importation of opium
Amendment (1912) to the Pure Food and Drug Act - ANS -Prohibited false or fraudulent
advertising claims
Harrison Narcotic Act of 1914 - ANS -Established regulations for opium, opiates and cocaine
(marijuana added in 1937)
Food, Drug, and Cosmetic Act of 1938 - ANS -required the new drugs be safe as well as pure
(but did not require proof of efficacy). enforcement by FDA
FDA basically originated from this law
Durham-Humphrey Amendment of 1952 - ANS -Vested in the FDA the power to determine
which products could be sold without prescriptions (and which products require prescriptions)
Kefauver-Harris Amendments (1962) to the Food, Drug, and Cosmetic Act - ANS -required
proof of efficacy as well as safety for new drugs released since 1938; established guideline for
reporting of information about adverse reactions, clinical testing and advertising of new drugs
Comprehensive Drug Abuse Prevention and Control Act of 1970 - ANS -outlined strict controls
in the manufacture, distribution, and prescribing of habit-forming drugs; established drug
schedules and programs to prevent and treat drug addiction
Orphan Drug Amendment of 1983 - ANS -Provided incentives for development of drugs that
treat diseases with fewer than 200,000 patients in the USA
Drug Price Competition and Patent Restoration Act of 1984 - ANS -abbreviated new drug
applications for generic drugs. required bioequivalence data. patent life extended by the amount
, of time the drug is delayed by the FDA review process. Cannot exceed 5 extra years or extend
more than 14 years post-NDA approval
Prescription Drug User Fee Act (1992, reauthorized 2007, 2012) - ANS -manufacturers pay
user fees for certain new drug applications
"breakthrough products may receive special category approval after expanded phase 1 trials
(2012)
Dietary Supplement Health and Education Act of 1994 - ANS -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
Bioterrorism Act of 2002 - ANS -Enhanced controls on dangerous biologic agents and toxins.
Seeks to protect safety of food, water, and drug supply
Food and Drug Administration Amendments Act of 2007 - ANS -Granted FDA grater 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
Gave the FDA greater authority over drug marketing and direct to consumer marketing
Role of the U.S. Food and Drug Administration (FDA) - ANS -ensuring safe drugs for public
consumption
approving new drugs for market and manufacture
conducting and monitoring clinical trials
New Drug Development - ANS -drug screening
preclinical safety and toxicity testing
evaluation in humans
drug screening - ANS -Manufacturer starts by screening several different molecules looking at
properties on a molecular level, cellular level, work in an organ system, and in animals
Optimize the drug compound to achieve the most desirable pharmacokinetic and
pharmacodynamic profile go back to the lab after making several different iterations of the drugs
and find that best compound with the most effective pharmacokinetic and pharmacodynamic
profile and move to preclinical testing
Preclinical safety and toxicity testing - ANS -o Animal studies
o Trying to identify any potential toxicities that could occur in humans
Drug Therapy
Office visit drug spending - ANS -$ 2.6 billion
Inpatient admissions drug spending - ANS -$329 million
emergency department visits drug spending - ANS -$ 286 million
Pure Food and Drug Act of 1906 - ANS -Prohibited mislabeling and adulteration of drugs
Opium Exclusion Act of 1909 - ANS -prohibited importation of opium
Amendment (1912) to the Pure Food and Drug Act - ANS -Prohibited false or fraudulent
advertising claims
Harrison Narcotic Act of 1914 - ANS -Established regulations for opium, opiates and cocaine
(marijuana added in 1937)
Food, Drug, and Cosmetic Act of 1938 - ANS -required the new drugs be safe as well as pure
(but did not require proof of efficacy). enforcement by FDA
FDA basically originated from this law
Durham-Humphrey Amendment of 1952 - ANS -Vested in the FDA the power to determine
which products could be sold without prescriptions (and which products require prescriptions)
Kefauver-Harris Amendments (1962) to the Food, Drug, and Cosmetic Act - ANS -required
proof of efficacy as well as safety for new drugs released since 1938; established guideline for
reporting of information about adverse reactions, clinical testing and advertising of new drugs
Comprehensive Drug Abuse Prevention and Control Act of 1970 - ANS -outlined strict controls
in the manufacture, distribution, and prescribing of habit-forming drugs; established drug
schedules and programs to prevent and treat drug addiction
Orphan Drug Amendment of 1983 - ANS -Provided incentives for development of drugs that
treat diseases with fewer than 200,000 patients in the USA
Drug Price Competition and Patent Restoration Act of 1984 - ANS -abbreviated new drug
applications for generic drugs. required bioequivalence data. patent life extended by the amount
, of time the drug is delayed by the FDA review process. Cannot exceed 5 extra years or extend
more than 14 years post-NDA approval
Prescription Drug User Fee Act (1992, reauthorized 2007, 2012) - ANS -manufacturers pay
user fees for certain new drug applications
"breakthrough products may receive special category approval after expanded phase 1 trials
(2012)
Dietary Supplement Health and Education Act of 1994 - ANS -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
Bioterrorism Act of 2002 - ANS -Enhanced controls on dangerous biologic agents and toxins.
Seeks to protect safety of food, water, and drug supply
Food and Drug Administration Amendments Act of 2007 - ANS -Granted FDA grater 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
Gave the FDA greater authority over drug marketing and direct to consumer marketing
Role of the U.S. Food and Drug Administration (FDA) - ANS -ensuring safe drugs for public
consumption
approving new drugs for market and manufacture
conducting and monitoring clinical trials
New Drug Development - ANS -drug screening
preclinical safety and toxicity testing
evaluation in humans
drug screening - ANS -Manufacturer starts by screening several different molecules looking at
properties on a molecular level, cellular level, work in an organ system, and in animals
Optimize the drug compound to achieve the most desirable pharmacokinetic and
pharmacodynamic profile go back to the lab after making several different iterations of the drugs
and find that best compound with the most effective pharmacokinetic and pharmacodynamic
profile and move to preclinical testing
Preclinical safety and toxicity testing - ANS -o Animal studies
o Trying to identify any potential toxicities that could occur in humans
