Pharmacological Legislation

Front 1

Federal Pure Food and Drug Act (1906)

Back 1

drugs must be free of adulterants, must be labeled accurately, weak restrictions

Front 2

Food, Drug and Cosmetic Act (1938)

Back 2

first legislation to regulate drug safety
a. all new drugs undergo testing for toxicity
b. test results were reviewed by the Food and Drug Administration (FDA) to receive approval for marketing

Front 3

Harris-Kefauver Amendments (1962)

Back 3

a. resulted from thalidomide induced birth defects – given to alleviate morning sickness
b. required proof of effectiveness before a new drug could be marketed
c. all old drugs introduced between 1932 and 1962 had to undergo testing for effectiveness, drugs that failed to prove useful were withdrawn from the public
d. rigorous FDA procedures/criteria instituted for testing new drugs, must disclose adverse reactions and contraindications

Front 4

Controlled Substances Act (1970)

Back 4

regulation of narcotics
a. established rules for the manufacture, distribution, and dispensing of drugs considered to have abuse potential
b. restricted persons who have dispensing privileges
c. classified controlled substances according to use and abuse potential
i. Schedule I, II, III, IV, V
ii. Schedule I = no accepted medical use, high abuse potential (EX: heroin)
iii. Schedule II→V=accepted medical applications but have abuse potential, progressively less physical dependence from II→V (V=least abuse potential)
d. nursing safeguards to prevent peer abuse
i. narcotic administration logs
ii. witness required for wasted doses
iii. responsibility to report physical dependence of peers to BNE/TAPAN

Front 5

Prescription Drug Users Fee Act (1992)

Back 5

a. accelerated approval of drugs by FDA, early approval balanced by more effective drugs to the public (came about with the emergence of HIV)
b. emergence of new drug trials (between 1990 (7,000) to 1997 (15,000) new drug trials conducted)
c. resulted in less testing; drug recalls

Front 6

Food and Drug Moderization Act (1997)

Back 6

a. widespread changes in FDA regulations
b. fast track approval process opened to more drug categories
c. inform patients at 6 months in advance of drug discontinuation
d. FDA can require that drugs be tested in children
e. creation of a clinical trials database
f. information of off-label use can be distributed with restrictions

Front 7

Best Pharmaceuticals for Children Act (2002) and Pediatric Research Equity Act (2003)

Back 7

a. promote research on drug efficacy and safety for children
b. require drug companies to conduct pediatric drug trials on medications that might be used by children

Front 8

FDA Amendment Act (FDAAA) (2007)

Back 8

a. allows FDA oversight of drug safety after a drug has been approved
b. legal authority to conduct post-marketing surveillance and recall drugs