FDA Issues Guidance on Medication Guide Statements

The US Food and Drug Administration released a new guidance for industry, Medication Guides-Adding a Toll-Free Number for Reporting Adverse Events, on June 8, 2009. Applicable to drug manufacturers that must have an FDA-approved Medication Guide under the Federal Food, Drug and Cosmetics Act, the guidance requires firms to include in their guides the agency’s toll-free MedWatch phone number for reporting side effects and a statement that the number is to be used for reporting purposes only.

Manufacturers must also notify FDA that the side effects statement has been added to their Medication Guides.  The guidance takes effect July 1, 2009. FDA issued a final rule on this topic in October 2008 (see back story, FDA Requires Side Effects Statement on Labeling).

The statement in the Medication Guide must be printed verbatim as follows: “Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.” The statement must go under the guide’s section titled, “What are the possible or reasonably likely side effects of (name of drug)?”

Changes to already existing medication guides can be reported to FDA via annual reports.