Pharmacology Laws And Gov. Agencies

Front 1

1906 Pure Food and Drug Act

Back 1

Drugs must be free of adulterants (says nothing about effectiveness or safety)

Front 2

1938 Food, Drug, & Cosmetic Act (FDA)

Back 2

First law to regulate safety.
Made in response to Sufanilamide elixar tragedy that caused kidney damage that led to many deaths.
New drugs screened for toxicity and results reviewed by FDA for approval

Front 3

1952 Durham Humphrey Amendment

Back 3

established prescription drug classes

allowed off-label use of drugs

Front 4

1962 Kefauver-Harris Amendment

Back 4

Required proof of efficacy.
Made in response to Thalidomide tragedy (given for morning sickness -> caused phocomelia in infants)
Created guidelines for drug testing reporting of adverse effects, toxicity, and safety,

Front 5

1970 Controlled Substance Act (Comprehensive Drug Abuse Prevention and Control Act)

Back 5

Drug Enforcement Administration (DEA) created rules surrounding drugs of abuse.
Drugs classified into 1 of 5 schedules (DEA#): 1 being highly addictive and not suitable for medical use (LSD, marijuanna, heroin), 5 being mildely addictive (codeine cough syrup).

Front 6

1984 Drug Price Competition and Patent Term Restoration Act

Back 6

Extended patents for innovator drugs and simiplified the new drug application for generic drugs

Front 7

1992 Accelerated Approval Act

Back 7

Drugs for the treatment of AIDS and cancer can skip phase IV of clinical trials and begin marketing with the promise to preform rigorous follow-up phase IV trials later

Front 8

1994 Dietary Supplement Health and Education Act (DHEA)

Back 8

exempts herbal supplements from FDA regulation if they are marketed as "dietary supplement"
Manufacturers must notify FDA of efficacy claims and they must be "truthful and not misleading"
FDA can intervene only after product has been marketed.

Front 9

1997 FDA Modernization Act

Back 9

fast-tracks drugs for serious disease.
Manufacturers must let patients know if they intend to stop making a drug
Created a clinical database of drugs for serious illnesses
Drug companies are allowed to distribute pamphlets on off-label uses
Incentives for pediatric research.

Front 10

2006 Dietary Supplement and Nonprescription Drug Consumer Protection Act

Back 10

Increased required drug adverse event reporting

Front 11

1910 Flexnor Report

Back 11

Mass evaluation of admission standards, facilities, qualifications, and instruction at american medical schools. Based off John Hopkins as Gold standard

Front 12

National Institutes of Health (NIH)

Back 12

Gov. agency for biomedical and health-related research.
Both conducts their own research and funds the research of other institutions

Front 13

Institutional Animal Care and Use Committee (IACUC)

Back 13

oversee animal research, issues animal welfare assurance #'s (required for gov. funding), and requires biannual inspections
Sets guidelines for reporting animal abuse

Front 14

Institutional Review Board (IRB)

Back 14

Oversees research with human subjects, protects the rights of participants (especially vulnerable subjects), requires informed consent.
Follow 3 ethical principles: respect, benefice, and justice

Front 15

US Pharmacopeia (USP)

Back 15

establishes standards of equivalence between brand and generic drugs: must be chemically equivalent and have the same bioavailability (same amount and rate of absorption)

Front 16

FDA Bioequivalence Standards

Back 16

Drugs classified as "A" or "B" drugs.
"A" drugs are bioequivalent (-20% to +25%) and interchangable.
"B" drugs are not equivalent and not interchangable
You may switch between "A" drugs without Dr. consent.