Mind Map Gallery history and evolution of drug regulation
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history and evolution of drug regulation
A mind map about history and evolution of drug regulation.
Edited at 2020-09-08 01:37:35
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History and Evolution of Drug Regulation
in charge of development, testing, and monitoring of new drugs
keep tabs on 95000 business
1 trillion woth of goods
reactive rather than proactive
typically as result of major crises
patchwork solutions
resolved the issue at hand but left other unresolved issues
beginning
mostt drugs imported this time
states exercised principal control over domestically produced and distributed food and drugs
control was markedly inconsistent from state to state
Patent medicines
miracle elixirs
cure aches, pains, rheumatism, gout and cancer
syrup
calm colicky babies and tonics for adults
listerine
prevent TB
crisis: adulterated and imported drugs 1848
mesican war of 1848
yellow fever
quinine claimed ineffective because adulterated
not proved
harmed pharm/doc rep
new york and phil coll of pharm passed law to congress
Drug Importation Act of 1848
all medications inspected by US CUSTOMS
owners or consignees recieved right to demand independent analystic esxaminations
recognized U.S. PHARMACOPEIA NGO that sets state-of-the-art standards to ansure quality of medicines
FDA
oldest reg dedicated to consumer pro
originated as single chemist in bureau of chemistry (USDA)
2009-11500 chemists,aksdjflkjsdhfljsdfh
crisis: death of children in 1901
tetanus constaminated serum of horse used to produce diphtheria antitoxin
(horse produced antibodies)
tetanus contaminated smallpox vaccine
attributed to failure of proper procedures and testing by local officials
Biologics Control Act 1902
biologics (antibodies, hard to characterize chemically)
required fed gov o issue premarket approval for biolodic dr
inspects establishments of manufacture
license these place annually
First Clinical Trials
in effort to inderstand preservative effects
trial design: 10 days of baseline, increasing levels therafter
seven prevalnt preservatives used
borax/boric acis
roaches
salicylic acid/salicylates
facewash
acne caused by bacterium, affective anti
benzoic acid and benzoates
above
Subtopic 2
sulphur dioxide and sulphites
wine pres
Subtopic 2
Subtopic 3
formaldehyde
enbalming
carcinogenic
Subtopic 6
copper sulfate
used in agr to kill microbes
potassium nitrate (saltpeter)
component of firework) yellow
the poison squad
no animal safety studies
no carcinogenic, mutagenic, or teratogenic studies
no institutional review board oversight
no informed consent forms for participants
no contorls, i.e. untreated group for comparison
of 7 preservatives studies, 4 are now banned
borax
sal acid
formal
coper sulfate
the muckrakers 1906
harvey wiley
inv food pred
Food and Drug Act (Wiley Act)
june 30 1906
first fed lw to regulate food and drugs
prohibits interstate comerce in misranded
charged buraeu of chemistry
required proper labeling
alcohol, morphine, heroin, and cocaine
11 total
samuel hopkins adams
questioning dangers of patent medicines)
uptonsinclair
question meat industry, wrote The Jungle, precipating force behind comprehensive food and drug law
crisis: Elixir Sulfanilamide
in tablet and powder form to treat streptococcal infections
had highly toxic variant of antifreeze
people died
Federal Food Drug and Cosmetic act 1938 (passed wiley act)
required manufacturers to show new drug was safe
required safe tolerances
drug must be given under direction of medical expert
???
crisis: contaminated antibiotic
phenoarbital antibiotic
led to good manufacturing practices
clinincal trials
1941 wwI
public health service act
crisis thalidomide babies 1962
sedative to control prgnant nausuea
led to baby deformites
these babies died
not approved in use merrell co, fda pharm kelsey disapproved
kafacuve arris ammednemtn
required drug manudacturs to notify fda before testing in humans
prove effective and safe
send adverse action reports
fair packaging and labeling act of 1966
consumer products to be labeled
identity,quantity, name od bussiness, place of manufacture
1970 first for contrap
Subtopic 2
crisis: tylenon adulterated subst with cyanise, no safety seals in packageing
Federal Anti tampering Act of 1982
crime to tamper with packaged consumer products
reuiwred on OTC drugs
distinctive by design
prominet, identified on label, provide visible evidence if tampering
otc sante TEP adulterated
GO THROUGH ALL AOTHER ACTS
Crisis: Pst market drug safety act
rezulin,
antiporozasx, only of adults