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FDA has asked drug makers to step up patient education with Medication Guides for certain drugs and biologics.

Better patient education has been one of FDA’s priorities in recent years, and the agency appears committed to it. In recent years, FDA has asked drug makers to step up patient education with Medication Guides for certain drugs and biologics. More than 200 prescription pharmaceuticals must be dispensed with Med Guides. They are also now required for certain entire classes of drugs, such as for nonsteroidal anti-inflammatory drugs.

To make sure that patients are getting the education they need from FDA’s Med Guide program, the agency will hold a public hearing on June 12–13, 2007. FDA wants to know whether drug risks are being covered sufficiently in these guides. “We want to hear from manufacturers, distributors, pharmacies, health professionals, and patients about what concrete steps can be taken to ensure that consumers get the information they need to make informed decisions about the use of medicines,” said Paul Seligman, MD, Associate Director for Safety Policy and Communication at FDA’s Center for Drug Evaluation and Research.

According to 21 CFR Part 208, Med Guides are required for products with one or more of the following characteristics:

• It is one for which patient labeling could help prevent serious adverse effects.
• It has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risk(s) could affect patients’ decisions to use, or continue to use, the product.
• The product is important to health, and patient adherence to directions for use is crucial to the effectiveness of the drug.

The public hearing on June 12 and 13 will be held on from 8:30 a.m. to 4:30 p.m. at the National Transportation and Safety Board Boardroom and Conference Center, 429 L’Enfant Plaza, S.W., Washington, DC 20594.

For more information on the meeting, including a link to the Federal Register Notice, please visit www.fda.gov/cder/meeting/medication_guides_200706.htm. For additional information on Medication Guides, visit www.fda.gov/cder/Offices/ ODS/medication_guides.htm.