FDA takes stance on off-label uses

The Food and Drug Administration has issued two guidelines to the pharmaceutical industry on what off-label information can be provided to the medical community.

The guidelines are intended to answer questions about how pharmaceutical companies and their reps can inform physicians and other prescribers about important research without confusing the results with FDA-approved indications.

The "Guidance to Industry on Dissemination of Reprints of Certain, Published Original Data" applies to articles that the FDA used to determine a drug's efficacy in the approval process. The articles may contain data, analyses, uses, regimens and other information that differs from the FDA's labeling of a drug.

The FDA stated that despite the potential for the dissemination of contradictory information, it would allow sponsors to share reprints of the articles with the medical community under certain circumstances:

•Â The principal subject of the article should be the use or indication approved by the FDA.

•Â The reprint should come from a journal that uses independent experts to objectively review and select, reject or provide comments about articles.

•Â If the article contains information that differs from the FDA-approved labeling, these differences should be clearly distinguished.

•Â The reprint should not mislead or contain false information.

The "Guidance for Industry-Funded Dissemination of Reference Texts" addresses industry's desire to provide the medical community with reference materials that discuss various medical diagnoses, treatments, product utilization and surgery techniques.

The FDA will allow the "distribution of sound, authoritative materials that are written, published and disseminated independent of the commercial interest of a sponsoring company and are not false or misleading." The agency cited six limitations for dissemination:

•Â The text cannot be written edited, excerpted or published for, or at the request of, a certain product or company. An exception could be made if the information is presented in fair balance.

•Â The material content should not be reviewed, edited or significantly influenced by a product, company or company representative unless the resulting material represents a balanced presentation of the subject matter.

•Â The text should not be distributed solely or primarily by product manufacturers. It has to be generally available through other avenues.

•Â The primary focus of the reference material should not be on one particular product or on unapproved uses of a particular product.

•Â Distributors of reference texts should not attach specific product information to the materials.

•Â A product's company representative should not "refer to, or otherwise promote, in any manner at any time, information in the reference text that is not consistent with the approved labeling for a product." PR