Exam 2: Laws Flashcards
Biologics Control Act
1902
Catalyst: Lack of regulation of purity, potency, ingredients, or standardization of drugs; children dies from tetanus from contaminated horse serum
Law: Established standards for VACCINES and ANTI-TOXINS
Food and Drug Act
1906
Catalyst: “The Jungle” exposed bad food packing practices
Law: Prohibited the manufacture, sale, or transportation of adulterated or misbranded or poisonous food, drugs, medicines, or liquors; CREATION of Food and Drug Administration (FDA)
Sherley Amendment
To the food and drug act of 1906
Catalyst: Supreme Court Ruled in US v Johnson the Food and Drug Act does not prevent companies from labeling remedies with any manner of false claims
Law: Congress prohibits labeling medicines with false claims to defraud the purchaser, must prove fraud with the following requirements (a false statement, knowledge that it is false, intent to deceive, reliance on statement by the consumer, injury as a result)
Harrison Narcotic Tax Act
1914
Catalyst: Narcotic/opium abuse in the newly US governed Philippine Islands and across the globe; Soothing syrup containing excessive amounts of morphine killing infants
Law: Required manufacturers, importers, pharmacists, and physicians to be licensed and taxed to handle narcotics
1st Rx, Rx required for narcotics
The Volstead Act
1920
Catalyst: 18th Amendment enacted prohibition but pharmacies still needed alcohol for medicinal purposes
Law: Creation of the “Liquor License” to limit the number of alcohol sources in an area, required Rx for alcohol, Walgreens boom due to the “Milkshake”
Food, Drug, and Cosmetic Act
1938
Catalyst: Sulfanilamide disaster
Law: Extend control of FDA to cosmetics and devices, requires drugs to be proven SAFE, FDA begins to identify drugs that require an Rx (no classification), Rx for habit-forming drugs, unsafe unless supervised by a health care practitioner (linking MD and pharmacist), remove Sherly requirement of fraud in misbranding, AUTHORIZES factory inspections
Durham-Humphrey
1951
Catalyst: Rx refills dispensed w/out authorization, barbiturates are OTC or multiple refills, sulfa drugs OTC
Law: OFFICIAL creation of drug legend (“Federal law prohibits dispensing w/out a prescription), Refills require authorization, directions/warning on non-Rx, label reqs on Rx
Kefauver-Harris Amendment
1962
Catalyst: Francis Kelsey of the FDA refuses to approve thalidomide because of the risk of children born with side effects
Law: Safety and EFFECTIVENESS must be proven to the FDA, advertisements to physicians balance pro/cons, FDA given jurisdiction over Rx drug advertising
MODERN day drug approval process
“The Controlled Substances Act”
Comprehensive Drug Abuse Prevention and Control Act
1970
Catalyst: Controlled substance abuse
Law: Created SCHEDULE of controlled substances
schedule II must be ordered using DEA form 222
Reqs of schedule drug rx for fax, e-prescribing, transfers, partial fills, record keeping, inventory and theft-requirements
Poison Prevention Packaging Act
1970
Catalyst: Children were opening containers and getting poisoned
Law: requires special packaging on household products to protect children from poisoning
Orphan Drug Act
Catalyst: Lack of R and d in areas with little financial incentive (small number of patients)
Law: Government creates incentive by adding additional tax deductions, extended exclusivity, subsidized research through funding to universities and companies
“Hatch-Waxman Act”
Drug Price Competition and Patent-Term Restoration Act
Catalyst: Generic drugs subjected to same testing requirements as their brand-name equivalents
Law: removed clinical req for generic bioequivalent drugs
added up to 5 year extension to patents to make up for R&D time
grants 180 market exclusivity to first generic drug
