The U.S. Food and Drug Administration (FDA) has just issued draft guidance for advertisements on prescription drugs and medical devices. The guidance is being distributed for comment purposes. The FDA says the guidance includes the factors the FDA takes into account regarding disclosure of risk information. The recommendations apply to promotional materials directed to consumers and health care professionals.

The FDA says in the draft Guidance that risk information is "critically important" to disclose in order to assist consumers in both understanding if drugs or devices may be appropriate for them and in understanding what they should tell their health care professionals before taking or using a product.

Some of the specific recommendations in the draft Guidance include:

--Language used to communicate benefits and risks should be comprehensible to the same audience in order for a promotion to be considered accurate and non-misleading. The promotional materials aimed at professionals can reasonably describe benefits and risks in medical terminology, however, those directed to consumers should mention benefits and risks in language understandable to consumers.

-- Risk information should be framed in the same terms or with the same degree of specificity as benefit information, in order not to mislead. As example if a product is referred to by name in presenting benefits, it should also be referred to by name in conveying risks, rather than a generic name. The FDA also says the phrases such as "Like all medicines, Drug x has some side effects," might minimize the message of risk severity.

--Consumer-oriented communications should generally convey: what purpose of the drug or device; for whom a drug or use a device is intended and who should not take/use it; what can be expected from a drug or device; what patients should ask their health care professionals about a drug or device; what patients should tell their health care professionals about before or while taking a drug or using a device

--A promotional piece should not just communicate the least serious risks, but ensure inclusion of the serious risks, as consumers have a mental schema that assumes the most serious risks will be part of the information in the promotion.

--Risk information should appear with or near benefit information, and as an integral part of the promotional piece (not, for example, just on a brief summary page). In addition, the FDA may object to substantially different font size for the risk information or risk information published in a difficult to read font size, as that might seriously reduce ability to comprehend the information.

The FDA says comments and suggestions regarding the draft guidance should be submitted within 90 days of its publication in the Federal Register. The address where comments may be sent is in the draft guidance (link below). The FDA states its guidance documents, including this draft guidance, are not legally enforceable rather serve to demonstrate the FDA's current thinking on a topic and should considered recommendations, unless specific regulatory or statutory requirements are cited. An alternative approach may be used if the approach satisfies the requirements of the applicable statutes and regulations, and any alternative approach may be discussed with the FDA.

Adapted from the FDA Guidance, available here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf

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