Regulatory History and Laws Flashcards
(32 cards)
Mrs. Winslow’s Soothing Syrup
Used for teething and colicky babies
- unlabeled, laced with morphine and killed many infants
- showed importance of providing drug labels
Mariana wine
Extract of cocaine recommended for depression
- was thought to be nonharmful
Upton Sinclair’s book “The Jungle”
Sinclair spent 7 weeks in meat packing plants of Chicago to observe social behaviors
- instead depicted poor and unsanitary working conditions
- 1906
Marketing a liquid sulfonamide preparation in 1937 by the Massengil Drug Company
Dissolved sulfanilamide in ethylene glycol
- resulted in 107 human deaths from renal failure
- could only be prosecuted for “misbranding”
- led to Food, Drug, and Cosmetic Act of 1938
Pure Food and Drug Act
Developed in 1906, prohibits interstate commerce in misbranded and adulterated foods, drinks, and drugs
- had very little authority
1938 Food, Drug, and Cosmetic Act
Required that a drug be safe
- efficacy did not have to be proven
- loophole: company was not mandated to share information, FDA could not routinely inspect records or facilities
Adverse event reporting regarding chloramphenicol by the Parke-Davis drug company
during the 1950s
Chloramphenicol was produced in 1949
- Parke-Davis knew of the drug’s propensity to cause blood dyscrasias, but they minimized/ignored the problem
- continued to recommend use of CHPC in situations where benign drugs would have worked
- led to several 100 human deaths
Kefauver-Harris amendment to the FD&C Act
1962, required that a drug be both safe and effective
- required post-market surveillance
- FDA must approve package labeling and be given broader inspection privileges
- more stringent manufacturing constraints (good manufacturing practices)
Durham-Humphrey Amendment to the FD&C Act
1951, separated OTC vs legend drugs (required a prescription)
- exemption for vet drugs
What FDA requirements must a company meet to get OTC designation for a veterinary drug?
- client can be reasonably sure of diagnosis
- client can administer medication properly according to label instructions
Food Additive Amendment to the FD&C Act
1958, food additives must be safe
- Delaney clause: set zero tolerance for a carcinogen in food
- was repealed in 1996 for nondrugs (pesticides), replaces zero-risk as the new safety standard
What was added to beer to maintain a foamy head, but also caused cardiomyopathy?
Cobalt salts
The Controlled Substances Act
Title 2 of the Comprehensive Drug Abuse Prevention and Control Act of 1970
- established Drug Enforcement Administration (DEA) for dealing with drugs of abuse
- creates schedules of drugs based on their medical utility vs their risk of abuse
- each schedule of drug requires a different record
- requires medical/veterinary practitioner to obtain a federal DEA license, separate from state license in order to obtain, use, dispense, or prescribe controlled drugs
Category 1 controlled drugs
No current medical use
- ex: heroin, LSD, ecstasy, marijuana
Category 2 controlled drugs
High potential for abuse and dependence
- written prescriptions, no refills
- ex: vicodin, cocaine, methadone, adderall, etc
Category 3 controlled drugs
Moderate to low risk of dependence, less abuse potential
- ex: tylenol with codeine, ketamine
Category 4 controlled drugs
Low potential for abuse and risk of dependence
- ex: xanax, valium, tramadol
Category 5 controlled drugs
Low potential for abuse, often with limited quantity of some narcotics
- ex: robitussin with codeine
Generic Animal Drug and Patent Term Restoration Act
1988, provides patent extension to compensate for regulatory approval process
- adds 1/2 of time from beginning of phase 1 trials to approval + time from final submission to approval, for up to 5 years
- allows for generic drug manufacturing
Patents normally last for _______
20 years
- may begin at any time before, during, or after actual approval by the FDA
Exclusivity of GADPTRA
Provision separate from patent protection, that prevents a generic drug from being approved in specific instances
- patents can be issued or expire at any time, regardless of the drug’s approval status
- exclusivity attaches upon approval of a drug product if the statutory requirements are met
Examples of when exclusivity may be granted
- human orphan drug exclusivity (7 years)
- new chemical entity exclusivity (5 years)
- generating antibiotic incentives now (5 years)
- human pediactric exclusivity (6 months)
- patent challenge (180 days)
Animal Medicinal Drug Use Clarification Act
1994, allows for extra label use of drugs by veterinarians if certain conditions are met
Animal Drug Availability Act
1996, intended to increase number of new animal drugs
- established the veterinary feed directive (VFD)
