1906

Required manufactures to indicate the amounts of alcohol, morphine, opium, cocaine, heroin, and marijuana extract on the label of each product

This gave the consumer the information necessary to make an informed decision

Added the requirement to existing law that labels should not contain "any statement … regarding the curative or therapeutic effect… which is false or fraudulent."

This amendment did not improve drug products but encouraged pharmaceutical companied to be more vague in their advertisements.

1938

The FDA was given control over drug safety after 107 people were killed by product produced by a drug company

Companies now had to file applications for new drugs with the government that they were safe

They did not have to be effective

1951

Established the criteria which determine whether a drug is to be classified as prescription or non-prescription

If a drug does not fall into one of the following categories it is considered nonprescription

The drug is habit-forming

The drug is not safe for self-medication due to its toxicity

The drug is new and lacks safety

Required

Manufactures to demonstrate effectiveness and safety of drug

Allowed FDA

Withdraw approval of a drug

Regulate/evaluate drug testing

All companies must follow a series of steps when seeking approval to market a new drug

Preclinical research and development

Clinical research and development

Permission to market

Fast-track rule

Orphan drug law

Estimated cost for OTC drug advertising

Estimated cost for Prescription drug advertising

Divided drugs with abuse potential into categories:

Schedule I through V

Schedule I

The drug or substance has high potential for abuse

The drug or substance has no currently accepted medical use in treatment in the US

There is a lack of accepted safety for use under medical supervision

Schedule II

The drug or substance has high potential for abuse

The drug or substance has a currently accepted medical use in treatment in the US

Abuse of the drug may lead to severe dependence

Schedule III

The drug or substance has less of a potential for abuse than in I and II

The drug or substance has a currently accepted medical use in treatment in the US

Abuse of the drug may lead to moderate or low dependence

Schedule IV

The drug or substance has low potential for abuse relative to III

The drug or substance has a currently accepted medical use in treatment in the US

Abuse of the drug may lead to limited dependence relative to III

Schedule V

The drug or substance has low potential for abuse relative to IV

The drug or substance has a currently accepted medical use in treatment in the US

Abuse of the drug may lead to limited dependence relative to IV

Schedule 1^st 2^nd

I Not < 5yr Not< 20

II Not < 5yr Not< 20

III Not > 5yr Not >10

IV Not > 3yr Not >6

V Not > 1yr Not >2

Drug reduction policy aimed at reducing the supply of illegal drugs and controlling therapeutic drugs

Attempts to decrease individuals tendency to use drugs primarily by reformulating values and behaviors

A method of abuse prevention that protects drug users by teaching them responsibility.

Can the FDA withdraw approval of an existing drug?

A drug must go through how many steps to become approved?

List the categories of drugs[sched]

What schedule drug is Marijuana?

Read Chapter #4, Addictive Behavior and Treating Drug Dependence (16 pgs.)

 

 

Be ready for a QUIZ!!!