The labeling, advertising, and promotion of drugs in the U.S., except for OTC drug advertising and promotion, is regulated by the Food and Drug Administration (FDA) under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to ensure that drugs are marketed in a truthful, accurate, and not misleading manner.
The labeling of drugs includes the information on the drug’s package, such as the prescribing information and patient information leaflet, which contains information about the drug’s intended use, dosage, and side effects. The labeling must be accurate and not misleading, and the FDA must approve it before the drug is marketed.
Drug advertising includes any communication that promotes the sale or use of a drug, including print, broadcast, and online advertising.
Promotion of drugs includes any activities, such as sales presentations or medical education events, that are intended to persuade healthcare professionals to prescribe or use a drug.
This course outlines the general FDA requirements for drug labeling, advertising, and promotion, and it covers the different regulatory frameworks between prescription and non-prescription drug labeling, advertising and promotion activities.
Learning points:
- General Labeling Requirements
- Rx Drug Labeling
- IND Drug Labeling and Promotion
- OTC Drug Labeling
- Drug Advertising and Promotional Labeling