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Important Safety Information (ISI)

Similar or Alternative Terms Meaning the Same Thing Major Statement, Fair Balance
Related Term(s) Brief Summary, Adequate Provision

Definitions

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FDA requires that drug product claim Direct-to-Consumer (DTC) ads must include "All the risks of using the drug." Under certain circumstances, however, ads can give only the most important risks. This is referred to as "Important Safety Information" or ISI for short.

In broadcast radio and TV ads (and telephone), ISI is referred to as the "major statement," which consists of the drug's most important risks. The major statement must be presented in a clear, conspicuous, and neutral manner. The risks are generally similar to the risks required for "fair balance" in print ads.

Omission or minimization of risk information is the most frequent violation of the regulations cited in advertising and promotion enforcement letters sent to sponsors, and illustrative research in one of the areas this guidance covers, direct-to-consumer prescription drug advertising, has shown that 60 percent of patients believe ads directed at them do not provide enough information about risks, 60 percent of physicians believe that patients have little or no understanding from these ads about what the possible risks and negative effects of the products are, and 72 percent of physicians believe that patients have little or no understanding from these ads about who should not use the product.

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