Drug: “Substances that produce a change in cellular or physiological functioning of humans.”
For Drugs... End-point of the supply chain drives demand
The five factors influencing prescribing behavior are:
Colleagues or other health care providers
Control and regulatory mechanisms
Demands by consumers and society
Promotional activities by drug manufacturers
Kickbacks from pharmaceutical companies
What are the two main acts used by the FDA to control pharmaceuticals?
Food, Drug, and Cosmetic Act
Public Health Service Act
Non-FDA-approved (“off-label”) indications are uses of a product that were not approved by the FDA, but have shown value after approval based on postmarketing research.
Non-FDA-approved indications can be promoted by the manufacturer.
The FDA started allowing direct advertising in what year?
Drug prices: Suggested price determined by manufacturer is usually a different price (much lower) that is actually paid out-of-pocket by most consumers based on their insurance plan.
This phase in the drug development is tested on non-human subject
Which of the phases allow human trail?
Phase 1 trials allow 20-80 people (for safety, dosing range, and side effects). Phase 2 trials allow 100-300 people (for effective and further evaluation of safety). Phase 3 trials allow how many people (to confirm effectiveness, monitor side effects, and compared it to commonly used treatments)?
Phase 4 trial - post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.