Lecture 3 part 3 Flashcards
Vaccine act of 1813 in response to smallpox vaccine; act made it so it had to go to a single distributor
Created a single federally-appointed agent, whose responsibilities were to:
preserve the genuine smallpox vaccine matter; and to furnish the same to any citizen of the United States, whenever it may be applied for, through the medium of the post-office (carried free of charge by the post office).
* Repealed May 4, 1822.
Drug Importation Act of 1848 in response to we were getting bad drugs from other countries
Drug Importation Act of 1848
Examined all __________ productsfor quality, purity and fitness for purpose.
Could reject, destroy or require second analysis at
importer’s expense.
* Established Pharmacopoeia of the U.S. and U.S.
Dispensatory as official standards for imported drugs only
* If used a second analyst, had to be a recognized
chemist.
Administered by the Department of the Treasury.
imported
Biologics are vaccines, derived from living organisms,antitoxins,immunologlobins
Biologics Control Act of 1902 in response to this act was passed because there was a tetanus outbreak among recipients of diphtheria vaccine in other words people were getting vaccinated for diphtheria and developing tetanus because there’s cross-contamination…most of the manufacturing facilities were on farms because most of your vaccines and antitoxins were derived from farm animals and now they were specific farms just made to do this…these manufacturers have to be licensed by treasury department in other words you have federal licensing…they also created a national sanitary board and that who was going to make regulations…Laws and agencies that make the regulations. We didn’t really have that with 2 prior laws…in the national sanitary board is made of surgeon generals of the army,navy and marine…each military branch had a surgeon general…there is no public health service yet..and they would get together to make up the regulations…
Drug Importation Act of 1848, and Biologics Control Act 1902 administered by Department of _______________
Treasury
Pure Food and Drug Act of 1906-muckracking journalism in other words there was a bunch of newspapers and women magazines and wrote about how bad the drug system was in the United States and that they were getting away with all sorts of things and nobody knew what was going on we were at a time where there is no controlled substance law… you know I want to put cocaine in coca cola hey go right ahead and sell it there is no prescription drug law yet
Pure Food and Drug Act of 1906
Defined “_________.”
Misdemeanor to make or sell ________or
misbranded drugs.
If retailer purchased in good faith, then held harmless for any damages.
Regulations promulgated jointly by the Treasury,Agriculture, and Commerce & Labor Departments
Bureau of Chemistry (in Agriculture Dept.) would perform any necessary tests
(wholesaler,manufacturer, and retailer could be held responsible)
drug
adulterated
U.S. Pharmacopoeia and National Formulary private agencies that write these reference books; these are not federal government reference books
Pure,Food, and Drug Act of 1906
Looking at all drugs in the United states not just those imported
Established U.S. Pharmacopoeia and National
Formulary as standards for U.S. drugs (not just imported); however, could be less than pure if so labeled. Did not use the U.S. Dispensatory as a standard.
Unfortunately, a U.S. Supreme Court (U.S. v. Johnson,221 U.S. 488 (1911)) opinion and the Sherley Amendment of 1912 hurt the act by requiring that for a label to be misbranding, it must be both false and fraudulent in its claims.
false and fradulent: wrong and intentionally want to do them
Harrison Anti-Narcotic Act of 1914
first attempt about doing something about controlled substances
(No prescription law yet;didn’t need a prescription back then)
Established control over the manufacture, distribution and dispensing of certain addictive substances (e.g., opium, morphine and cocaine) in ________________, primarily through taxation and required labeling.
high concentrations
Food, Drug, and Cosmetic Act of 1938 looks at SAFETY!!
Food, Drug, and Cosmetic Act of 1938–>This is the first time we had a law addressing the SAFETY because there was product called sulfonamide a sulfur drug…sulfur drugs are not very soluble in water and they are very hard to make into liquid forms
Sulfonamide doesn’t have alcohol in it…it has diethylene glycol and its in antifreeze…humans have a negative effect of this drug and it will kill someone…if sanitary plant, can prosecute individual board members
Food, Drug and Cosmetic Act of 1938
Definition of “drug” expanded:
to include affecting body structures even in the absence of disease (prevention)
by addition of the Homeopathic Pharmacopoeia of the U.S. as a standard
FDA’s enforcement powers were increased:
seizure (vs. recall) was allowed
plants could be closed
corporate officers could be prosecuted (“piercing the corporate veil”)
created Food,Drug, and Administration (so created FDA)
Food, Drug, and Cosmetic Act of 1938
“Adulteration” was better defined.
Drug labeling requirements became more
strict - misbranded meant claims were false
OR fraudulent.
There was an exemption to the labeling requirements created for products not intended for consumer use. (Only concerned with human use stuff)
Durham-Humphrey Amendment or
Prescription Drug Amendment of 1951
created prescription drug law
Established two classes of drugs -
prescription and over-the-counter - to be
determined by the FDA, and the methods
by which consumers could obtain each
Established label and labeling requirements
unique to prescription drugs (exempted
from “adequate directions for use”
requirement)
Food Additives Amendment 1958
Color Additive Amendment 1960
_______Additive: Required premarket approval of additives for safety and Delaney Clause – none may cause cancer (in animals).
_________Additive: Required premarket approval for safety; can selectively approve additive for specific uses; and Delaney Clause – none may cause cancer.
food, color
Drug Efficacy Amendment of 1962
(or Kefauver-Harris Amendment)
In response to?in response to thalidomide and it was used in pregnant women usually in first trimester of pregnancy to help with nausea and there is high incidence of malformation of the limbs and the limbs wouldn’t develop most of these cases happened in Europe because thalimonide
was not approved for the US… Good manufacturing practices these are regulations that the fda made up…if you want to make penicillin you have to make it in a separate room
looking at ___________
Established ____________ Practices
(“GMPs”) - standards for pharmaceutical
industry
Transferred regulation of prescription drug
advertising from the Federal Trade
Commission (“FTC”) to the FDA:
– OTC Advertising - still with FTC
– Trademark Law - private party action
Efficacy
Good manufacturing practices
FDA regulates advertising of prescription drugs only and not nonprescription drugs
OTC advertising is under federal trade commission!!
Drug Efficacy Amendment of 1962
- Regulation of prescription drug advertising
under the FDA (continued):
– Prescription Drug Advertising by Manufacturer
to Health Professionals - FDA
– Prescription Drug Advertising by Manufacturer
to Consumer – FDA
Required ___________of all human
research studies
informed consent
Drug Efficacy Amendment of 1962
Required reporting of adverse drug reactions
by manufacturers to FDA (in addition,
voluntary reporting is available).
New drug approval now required proof of
__________ in addition to safety, and was made
retroactive to all drugs approved since 1938
(resulting in Drug Efficacy Study
Implementation (“DESI drugs”))
efficacy
Phase I, Phase II, and Phase II trials are on humans!
Phase I involves healthy people and they don’t have the disease,looking at safety)
Phase II 100 to 300 with the disease that drug treats (looking at safety)
Phase III 5,000 to 10,000 all the people have the disease and does it work and its about efficacy
