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Pharmacology 1 > Regulatory History and Laws > Flashcards

Regulatory History and Laws Flashcards

1
Q

Mrs. Winslow’s Soothing Syrup

A

Used for teething and colicky babies

  • unlabeled, laced with morphine and killed many infants
  • showed importance of providing drug labels
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2
Q

Mariana wine

A

Extract of cocaine recommended for depression

- was thought to be nonharmful

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3
Q

Upton Sinclair’s book “The Jungle”

A

Sinclair spent 7 weeks in meat packing plants of Chicago to observe social behaviors

  • instead depicted poor and unsanitary working conditions
  • 1906
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4
Q

Marketing a liquid sulfonamide preparation in 1937 by the Massengil Drug Company

A

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
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5
Q

Pure Food and Drug Act

A

Developed in 1906, prohibits interstate commerce in misbranded and adulterated foods, drinks, and drugs
- had very little authority

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6
Q

1938 Food, Drug, and Cosmetic Act

A

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
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7
Q

Adverse event reporting regarding chloramphenicol by the Parke-Davis drug company
during the 1950s

A

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
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8
Q

Kefauver-Harris amendment to the FD&C Act

A

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)
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9
Q

Durham-Humphrey Amendment to the FD&C Act

A

1951, separated OTC vs legend drugs (required a prescription)
- exemption for vet drugs

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10
Q

What FDA requirements must a company meet to get OTC designation for a veterinary drug?

A
  • client can be reasonably sure of diagnosis

- client can administer medication properly according to label instructions

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11
Q

Food Additive Amendment to the FD&C Act

A

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
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12
Q

What was added to beer to maintain a foamy head, but also caused cardiomyopathy?

A

Cobalt salts

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13
Q

The Controlled Substances Act

A

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
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14
Q

Category 1 controlled drugs

A

No current medical use

- ex: heroin, LSD, ecstasy, marijuana

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15
Q

Category 2 controlled drugs

A

High potential for abuse and dependence

  • written prescriptions, no refills
  • ex: vicodin, cocaine, methadone, adderall, etc
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16
Q

Category 3 controlled drugs

A

Moderate to low risk of dependence, less abuse potential

- ex: tylenol with codeine, ketamine

17
Q

Category 4 controlled drugs

A

Low potential for abuse and risk of dependence

- ex: xanax, valium, tramadol

18
Q

Category 5 controlled drugs

A

Low potential for abuse, often with limited quantity of some narcotics
- ex: robitussin with codeine

19
Q

Generic Animal Drug and Patent Term Restoration Act

A

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
20
Q

Patents normally last for _______

A

20 years

- may begin at any time before, during, or after actual approval by the FDA

21
Q

Exclusivity of GADPTRA

A

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
22
Q

Examples of when exclusivity may be granted

A
  • 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)
23
Q

Animal Medicinal Drug Use Clarification Act

A

1994, allows for extra label use of drugs by veterinarians if certain conditions are met

24
Q

Animal Drug Availability Act

A

1996, intended to increase number of new animal drugs

- established the veterinary feed directive (VFD)

25
Q

Veterinary Feed Directive

A

Prior to this, all medicated feeds were OTC

  • not a prescription feed permit!
  • drugs with a VFD medicated feed may be prescribed by a vet only
  • extra label use is not allowed!!
26
Q

Medically Important Antimicrobials, Guidance for Industry

A

I: important
H: highly important
C: critically important (most restrictions)

27
Q

Minor Use/Minor Species Act

A

2004, added incentives for drug companies to develop drugs to be used in either:

  • major use in minor species
  • minor use in major species
28
Q

Animal Drug User Fee Act & Animal Generic Drug User Fee Act

A

2008, set up user fees by drug companies to hire staff and provide resources to decrease time for the drug approval process

29
Q

Veterinary Medicine Mobility Act

A

2014, amended the Controlled Substances Act to allow a veterinarian with a DEA registration to transport and dispense controlled substances at a site other than the vet’s principal place of practice
- as long as the distant site is located in a state where the vet is licensed to practice

30
Q

Veterinary Feed Directive Amendment

A

2015, eliminates use of medically important antimicrobials for growth promotion and feed efficiency
- brings therapeutic use in feed and water under the supervision of vets through VFDs

31
Q

Virus-Serum-Toxin Act

A

1913, initially created due to significant losses from unregulated manufacture and distribution of the anti-hog cholera antiserum
- gives USDA regulatory control over vaccines, biologics, and patient-side diagnostics for animals

32
Q

Federal Insecticide, Fungicide, and Rodenticide Act

A

Provides for federal regulation of pesticide distribution, sale, and use

  • EPA took over responsibilities in 1970
  • revision in 1972: replaced original law

Pharmacology 1 (15 decks)

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