Adequate Provision

Similar or Alternative Terms Meaning the Same Thing	NA
Related Term(s)	Brief Summary

An alternative way for drug companies to provide risk information about a drug in a broadcast ad. Drug companies generally must include all of a drug's risk information in a product claim ad. In print ads, they usually do this in the "brief summary." This brief summary would take many minutes to read or scroll down a TV screen. The law allows broadcast ads to include only the most important risk information if the ads tell viewers or listeners how to get the full FDA-approved prescribing information, which has all the drug's risks. To meet the "adequate provision" requirement, the broadcast ad must provide ways to find the drug's FDA-approved prescribing information.

Broadcast ads can meet the "adequate provision" requirement by giving a number of sources for finding a drug's prescribing information. These include:

• A healthcare provider (for example, a doctor)
• A toll-free telephone number
• The current issue of a magazine that contains a print ad
• A Web site address

The exemption does not apply to products with black box warnings in their approved product labeling. Source: FDA, Advertising/Labeling Definitions