Chapter 3

Question 1

patent medicine

Answer 1

signifies that the ingredients were secret, not patent

Question 2

Pure Food and Drug Act

Answer 2

required manufacturers to include on labels the amounts of alcohol, morphine, opium, cocaine, heroin, or marijuana extract in each product
did not prohibit distribution of dangerous preparations

Question 3

The Sherley Amendment

Answer 3

1912
accuracy of manufacturers’ therapeutic claims was not controlled by the Pure Food and Drug Act

the Sherley Amendment in 1912 was passed to strengthen existing laws and required that labels should not contain “any statement.. regarding the curative or therapeutic effect.. which is false and fraudulent.”

Question 4

Food, drug, and cosmetic act

Answer 4

the sale and use of Elixir Sulfanilamide led to a tragic accident that killed over 100 people

companies required to file applications with the government showing that new drugs were safe

Question 5

Durham-Humphrey Amendment

Answer 5

made formal distinction between prescription and nonprescription drugs

Question 6

Kefauver-Harris Amendments

Answer 6

passed, in part, as a consequence of the thalidomide tragedy
drug manufacturers had to demonstrate the efficacy and safety of drugs
the FDA was empowered to withdraw approval of a drug that was already being marked

Question 7

Regulatory steps for new prescription drugs

Answer 7

Step 1:
preclinical research and development

Step 2:
clinical research and development
  -initial clinical stage
  -clinical pharmacological
  -evaluation stage

Step 3: permission to market
-postmarketing surveillance

Question 8

“Fast-track” rule

Answer 8

applied to testing of certain drugs, such as ones for rare cancers and AIDS

Question 9

Direct-to-consumer (DTC) Advertising

Answer 9

most physicians surveyed agreed that because their patient saw a DTC advertisement, he/she asked thoughtful questions during the visit. Approximately the same percentage of physicians thought the advertisements made their patients more aware of possible treatments.

Question 10

Drug court

Answer 10

• designed to deal with nonviolent, drug-abusing offenders
• integrate mandatory drug testing, substance abuse treatment, sanctions, and incentives in a judicially supervised setting