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The Clinical Pharmacology Sections in Drug Package Inserts: Do We Need to Reexamine the Basis?

The package insert of a drug product accomplishes two important objectives. First, it is an authoritative source of information for prescribing physicians in ensuring the use of the drug safely and effectively for indications where the US Food and Drug Administration (FDA) has determined that the drug has acceptable safety and efficacy. Second, it is a limiting document on the manufacturer’s (i.e., sponsor) advertising of it’s product, such that the promotion of the product conforms to the claims stated in it’s package insert. In practice, there is significant room for improvement in how successfully these two objectives are fulfilled. The package insert does not appear to be as authoritative as it could be, given that new information generated is not routinely updated unless there is an explicit request by a health authority or when a file for a new indication is submitted by the manufacturer. Second, due to the promotional considerations of content with a package insert, content is limited to verifiable and primary source data generated during the course of regulatory drug development and postapproval commitments. There are no mechanisms currently wherein data generated by a third party, such as an academic laboratory or a clinical trial center, are included in the package insert. These aspects are further analyzed.