FDA

Health Psychology

• FDA = Food & Drug Administration

• Part of Dept of Health & __________ Services

Products FDA Regulates

• Food & ___________ Supplements

• Drugs• Medical Devices• Biologics

• Animal Feed & Drugs• Cosmetics• ___________ -

Emitting Products

Stage 1: Preclinical Research

• Drug Discovered

• ___________ Research– Harmful effects– How works

• FDA: Investigational New Drug Application

Stage 2: Clinical Research

• ___________ clinical trials

• Overseen by: – pharmaceutical co– physicians– regulatory authorities– safety & ethics

committee

Phase I

• ___________ volunteers, not taking other meds

• Small groups

• Determines: How body processes, responds to, is affected by drug

• Test low & high ___________

Phase II

• Pts w/ disease or disorder only, no other meds

• Small controlled trials

• Determines: drug's _______________, side effects, general effectiveness

Phase III

• Pts w/other diseases/disorders, other meds

• Large controlled trials

• ___________

Phase IV

• After initial FDA approval

• Specific populations

• More safety investigations

Stage 3: FDA Review & Approval

• New Drug Application– pharm co reports all results to FDA

• Approval if safe & ___________

Stage 4: Marketing

• Drug available to drs & pts

• For ___________ only

• Maybe research on other uses

Controlled Trials

• Placebo: pt thinks getting something

• ___________ _______: all get some drug

• Active-tx: other known effective drug

• No tx

• Historical: compare past mortality rates

Placebo Types

• Sugar pills

• Waiting

• History-taking

• Injections• _________________

• Active placebos

Placebo effects

• ~ ___% of clinical effect

• Often bigger than drug’s effect

• Placebo addiction & withdrawal

Individual characteristics

• Older

• Women

• ___________

• Hi neuroticism

Psych Factors

• Expectancy–Faith, hope,

suggestibility–Pt & ________

–Pos & neg

• Credibility–Of dr & tx– Ointment<pill<injection

Mechanisms

• Spontaneous remission

• Classical conditioning

• Cognitive theory

• _______________

• Physiological explanations