Acts, Amendments and Court Rulings timeline

Question 1

What the 1906 Pure Food and Drug Act did

Answer 1

1. first law to regulate meds
2. recognized USP and NF as standard drug references
3. defined adulteration and misbranding and assigned penalties for each
4. established the FDA as responsible party for penalties

Question 2

1911 US v Johnson

Answer 2

showed that PF&DA only prevented false statements regarding a drugs identity and not false or misleading claims about its efficacy

Question 3

1912 Shirley Amendment

Answer 3

1. amended PF&DA bc of US v Johnson
2. made it illegal for manufacturers to have intentionally misleading claims about drug effectiveness

Question 4

1938 Food, Drug and Cosmetic Act

Answer 4

1. rqrd new drugs be SAFE before market
2. repealed Shirley amend.
3. authorized factory inspections

Question 5

Which event most directly led to the passing of the 1938 Federal Food, Drug and Cosmetic Act?

Answer 5

The Elixir Sulfanilamide Tragedy (1937)

Question 6

1950 Alberty Food Products Co. v US

Answer 6

‘adequate directions for use’

in order for a drug to say this (and be OTC?), it must state the purpose and conditions for which the drug was intended to be used and sufficient info for a layman to be able to safely and intelligibly self medicate

Question 7

1951 Durham-Humphrey Amendment

Answer 7

1. amended 1938 Food, drug and cosmetic act
2. OTC meds distinguishable from prescription only drugs and required ‘adequate directions for use’
3. prescription only drugs needed the statement: “caution: federal law prohibits dispensing without a prescription”
4. allowed verbal transmission of prescriptions and refills for prescriptions

Question 8

1962 Kefauver-Harris Amendment

Answer 8

1. amended the food, drug and cosmetic act
2. required drugs be SAFE and EFFECTIVE (applied to drugs marketed btwn 1938-1962)
3. Rx drug advertising transferred from FTC to FDA
4. research: informed consent of pts and reporting of ADR

Question 9

1968 Drug Efficacy and Safety Implementation (DESI)

Answer 9

1. reviewed all medications approved 1938-1962 for efficacy (bc they were previously only reviewed for safety)
2. product stays on market until decision is made (some are still on market today)

Question 10

1983 Orphan Drug Act

Answer 10

1. lower statistical burden for safety and efficacy when appropriate
2. tax incentives
3. enhanced patent protection and marketing
4. clinical research subsidies
5. gov. incentive to engage in drug research

for drugs for less studied and more rare disease states

Question 11

1984 Hatch-Waxman Act
-AKA: the drug price competition and patent term restoration act

Answer 11

1. reduced the requirements of approval for generic prescription drugs
2. companies can now prepare for approval w/o impinging on brand name patent
3. companies only had to prove bio-equivalence and acceptable manufacturing practices

Question 12

1970 Poison Prevention Packaging Act (PPPA)

Answer 12

1. defined special packaging
2. compliant if after 10 minutes, 80% of children under 5 cannot open special packaging, even with instructions
3. compliant if 90% of normal adults are able to open within 10 minutes

Question 13

1982 Chicago Tylenol Murders significance

Answer 13

1. led to tampering being treated as a crime (federal anti-tampering act of 1983)
2. led to the requiring of tamper-evident packaging

Question 14

1990 Omnibus Budget Reconciliation Act (OBRA ‘90)

Answer 14

1. targeted spending on medications by Medicaid benficiaries
2. rqrd: prospective DUR, retrospective DUR, offer to counsel pt, maintain pt records

Question 15

1994 Dietary Supplement Health and Education Act (DSHEA)

Answer 15

1. defined dietary supplement as product intended to supplement the diet containing one or more of: vitamin, mineral, herb or other botanical, amino acid