Ch 3: Drug Regulation, Development, Names, and Information

Question 1

What was the first American law to regulate drugs?

Answer 1

The Federal Pure Food and Drug Act of 1906.

p. 14

Question 2

When was the Food, Drug and Cosmetic Act passed? What was the motivation behind this law? (p. 14)

Answer 2

1938. A tragedy in which more than 100 people died from taking a new medication. This medication contained antifreeze as its solubilizing agent.

Question 3

What is the technical name for antifreeze? (p. 14)

Answer 3

diethylene glycol

Question 4

What amendments to the Food, Drug and Cosmetic Act were passed in 1962? What was this bill created in response to?

Answer 4

The Harris-Kefauver Amendments. The thalidomide tragedy that occurred in Europe in the early 1960’s.
(p. 14)

Question 5

What is thalidomide? What does it cause? (p. 14)

Answer 5

A sedative widely used to treat insomnia and morning sickness. It is now known to cause birth defects and fetal death. Specifically, it caused phocomelia, which is the gross malformation or complete absence of arms or legs.

Question 6

What did the Harris-Kefauver Amendments now require? (p. 14)

Answer 6

1. They required that drugs be proven effective before being marketed.
2. They required that all drugs introduced between 1932 and 1962 undergo testing for effectiveness. Any which failed testing were withdrawn from the market.
3. They established rigorous procedures for testing new drugs.

Question 7

What legislation regarding drugs was passed in 1970?

Answer 7

The Controlled Substances Act. This act set rules for the manufacture and distribution of drugs considered to have the potential for abuse. It defines five classes of drugs: Schedules I, II, III, IV, and V.
(p. 14)

Question 8

What is a Schedule I drug? (p. 14)

Answer 8

A drug which has no accepted medical use in the U. S. and is deemed to have a high potential for abuse. Includes heroin, mescaline (peyote), and lysergic acid diethylamide (LSD).

Question 9

In 1992, FDA regulations were changed to permit accelerated approval of drugs for…. (p. 14)

Answer 9

AIDS and cancer

Question 10

What was the Prescription Drug User Fee Act (PDUFA) passed in response to? What year was it passed? (p. 15)

Answer 10

Complaints that the FDA takes too long to review applications for new drugs; 1992.

Question 11

What were the provisions of the PDUFA? What was the end result?

Answer 11

It allowed drug sponsors to pay the FDA fees that are used to fund additional reviewers. In return, the FDA must adhere to strict review timetables.
New drugs reach the market much sooner than in the past.

Question 12

What is considered to be the most important legislation on drug safety since the Harris-Kefauver Amendments of 1962?

Answer 12

The FDA Amendments Act (FDAAA) of 2007

(p. 15)

Question 13

The FDAAA expands the mission of the FDA to include rigorous oversight of…

Answer 13

…drug safety AFTER a drug has been approved.

p. 15

Question 14

What is the major difference between preclinical testing and clinical testing?

Answer 14

Preclinical testing is done on animals, clinical testing is done on humans.
(p. 16)

Question 15

What happens during preclinical testing?

How long does this phase take?

Answer 15

Drugs are tested on animals and evaluated for toxicities, pharmacokinetic properties, and potentially useful biologic effects.
1 - 5 years
(p. 16)

Question 16

About half of the drugs that reach the market have…

Answer 16

…serious adverse effects that were not detected until after they were released for general use.
(p. 17)

Question 17

When thinking about prescribing a new drug, clinicians would do well to follow this guideline:

Answer 17

Be neither the first to adopt the new nor the last to abandon the old.
(p. 17)

Question 18

Trade names of drugs are not supposed to…

Answer 18

…imply efficacy.

(p. 18)

Question 19

What is allocation bias?

What is used to prevent it?

Answer 19

Allocation bias occurs when subjects in the experimental group are different (e. g. less sick, younger, etc) than those in the control group. Randomization is used to prevent allocation bias.

(p. 16)

Question 20

Phase I trials are usually conducted on _______ __________ and have three goals:

Answer 20

healthy volunteers

1) evaluating drug metabolism
2) pharmacokinetics
3) biologic effects

(p. 16)

Question 21

Phase II trials are conducted on ________ and are done to evaluate….

Answer 21

patients
therapeutic utility and dosage range

(p. 16)

Question 22

Phase III trials are conducted on ________ and are done to evaluate…

Answer 22

patients
safety and effectiveness

(p. 16)