PHRM 5110 FDA Laws

Question 1

Pure Food and Drugs Act 1906

Answer 1

pure food only across state lines

Question 2

Food, Drug, and Cosmetic Act 1938

Answer 2

drug is safe, application to FDA prior to marketing; ex: is this eyelash dye safe?

Question 3

Durham-Humphrey Amendment 1951

Answer 3

for sale by prescription only

Question 4

Kefauver-Harris Drug Amendments 1962

Answer 4

informed consent from subject and report effects/GMP

Question 5

Orphan Drug Act 1983

Answer 5

drugs that treat rare diseases; 7 years marketing exclusive

Question 6

Drug Price Competition and Patent Term Restoration Act 1984

Answer 6

brand patent 14 years max, 180 days market exclusive first generic drug

Question 7

Prescription Drug User Fee Act 1992

Answer 7

drug companies pay user fees

Question 8

Food and Drug Modernization Act 1997

Answer 8

6 months exclusive for research for kids

Question 9

Public Health Security and Bioterrorism Preparedness and Response
Act 2002

Answer 9

respond to public health emergencies; controls over imported/domestic commodities

Question 10

4 major functions of FDA (FDMA)

Answer 10

• review, research, approve
• product safety/labeling
• collab with other countries
• cooperate with scientist/consumers