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Pharm Law > Lect 2 Regs of Medications > Flashcards

Lect 2 Regs of Medications Flashcards

1
Q

Pure food and drug act of 1906

A
  • brought on by Upton Sinclair’s “The Jungle”
  • Prohibited the adulteration and misbranding of food/meds
  • Amended in 1912, prohibit false efficacy claims
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2
Q

Sulfanilamide Elixir

A
  • circa 1937, Massengil reported a demand for liquid form of drug
  • diethylene glycol solvent was used
  • 107 deaths (renal failure and seizures)
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3
Q

Food, Drug, and Cosmetic act of 1938

A
  • no new drug could be marketed until proven safe for use and approved by FDA
  • labels must contain adequate directions and warnings
  • pre1938 drugs exempt
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4
Q

Roles of FDA

A
  • Rulemaking
  • Issue guidance documents
  • Incorporate advice from standing advisory committees of outside experts
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5
Q

Durham-Humphrey Amendment of 1951

A
  • Established 2 classes of drugs (OTC and RX)
  • RX: those that required medical supervision and a warning “caution, federal law prohibits dispensing w/o rx”
  • OTC:do not require medical supervision (still need labeling)
  • Authorized oral scripts/refills
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6
Q

Thalidomide Tragedy of 1961

A
  • sleep aid and antiemetic for morning sickness
  • Dr. Frances Kelsey had concerns
  • 10,000 flipper babies
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7
Q

Thalidomide Today

A
  • in 2006, approved for multiple myeloma (w/dexamethasone)
  • only dispensed under STEPS
  • available only to approved professionals
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8
Q

REMS programs

A 
-Risk evaluation and mitigation tool
CAN include:
-distribution of a medication guide
-Registries
-Provider training
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9
Q

Kefauver-Harris Amendment of 1962

A
  • AKA drug efficacy amendment
  • required drugs to be proven safe and effective to be approved
  • transferred rx drugs advertising from FTC to FDA
  • established GMPs
  • required informed consent and ADR reporting
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10
Q

Orphan drug act of 1983

A

-provided tax and license incentives for manufacturers who developed drugs for rare diseases/conditions (<200K)

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11
Q

Wax Hatchman Amendment

A
  • AKA drug price competition and patent term restoration act of 1984
  • streamlined the generic drug approval process while giving patent extensions for innovative drugs
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12
Q

Prescription drug marketing act of 1987

A
  • in repsonse to diversionay distribution systems
  • required restrictions and recordkeeping for samples
  • prevented medical centers from reselling stock
  • required licensing of drug wholesalers
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13
Q

Patient protection and ACA of 2010

A
  • mandate all individuals have health insurance
  • set up exchanges for companies to compete
  • phase out donut hole
  • stop brand/generic collusion
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14
Q

What is a drug?

A
  • article in the USP/NF
  • article intended to diagnose, cure, mitigate, treat, or prevent disease
  • article intended to affect structure or function of the body
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15
Q

Special food categories

A 
Legal categories
-special dietary foods
-medical foods
Publicly conceived categories
-Nutraceuticals
-functional foods
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16
Q

Class I recall

A

Reasonable probability product will cause serious health consequences or death (heparin 2008)

17
Q

Class II recall

A

Product may cause temporary or reversible adverse effects (Ketorolac 2010)

18
Q

Class III recall

A

Product unlikely to cause adverse health consequences

19
Q

Adulteration

A

1) consists of any filthy, putrid, or decomposed substances
2) represented as the drug not recognized in USP. wrong strength, or quality/purity below USP standards
3) mixed or packed therwith so as to reduce quality/strength

20
Q

Federal Anti-tampering act

A

Act requires certain OTC drugs, cosmetics, and devices be manufactured in tmaper resistant packaging

21
Q

Misbranding

A
  • label can’t be false/misleading
  • label must include active ingredients (in alpha)
  • adequate directions for/warnings against use
  • cannot imitate another drug
22
Q

Adulteration vs Misbranding

A

A:deals with drug’s strength, purity, and quality
M: focuses on representations made by the manufacturer on the label

23
Q

Pregnancy A

A

Adequate studies have not demonstrated a risk to fetus

24
Q

Pregnancy B

A

Animal studies failed to demonstrate risk to fetus

25
Q

Pregnancy C

A

Either animal have shown an adverse effect or there are no animal/human studies

26
Q

Pregnancy D

A

Positive evidence of fetal risk exists based on investigational or marketing reports

27
Q

Pregnancy X

A

Studies (animal or human) demonstrate risk clearly outweighs benefit

28
Q

Investigation of New Drug Application (INDA)

A
  • composed of preclinical data which reflects both use and safety in animal trials
  • FDA has 30 days to decide if suitable for testing
  • After approval, may initate human trials
29
Q

3 phases to human trials

A
  • 1 and 2 conducted by manufacturer

- 3 conducted independently at remote clinical site with manufacturer sponsorship

30
Q

Prescription Drug User Fee Act

A
  • submission fees allowed FDA to hire hundreds of extra reviewers
  • discouraged submission of low probability NDAs
  • P and S ratings
31
Q

Priority rating (in NDA)

A
  • no other effective drugs available
  • more effective or safer than current available drugs
  • important advantage (convenient, less AE, etc)
32
Q

Supplemental NDA

A
  • manufacturers must use these to make changes (even minor) to drug or labeling
  • lower priorities may take years
33
Q

Abbreviated NDA

A
  • for generic drugs
  • proof of safety/efficacy not required
  • rather proof of bioequivalence and acceptable manufacturing methods are required
  • created by Wax-Hatchman
34
Q

Controversial Innovator drug manufacturer practices

A
  • producing “authorized generics”
  • 30 month stay from ANDA approval awarded when a patent holder sues for patent infringement
  • filing of 2ndary patents often for produt changes and attempts to shift market share to new product
  • Exclusion payments
35
Q

Phase 1 testing

A
  • small group of healthy people

- to evaluate the drug’s toxicological, PK/PD, and safety in humans

36
Q

Phase 2 testing

A
  • larger group (100+) with the disease

- determine efficacy, dose, range, safety, and adverse effects

37
Q

Phase 3 testing

A
  • larger group (1000+)

- determine effectiveness compared to placebo

38
Q

Phase 4 testing

A
  • postmarketing surveillance

- required to submit ADRs ro FDA

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