FDA will initially apply its MedGuide rule only to drug classes where the agency has already asked for patient-directed labeling, the agency said in its final rule "Prescription Drug Product Labeling; Medication Guide Requirements," published Dec. 1.

"At this time, the only currently marketed products for which FDA intends to require medication guides are products in classes for which FDA has requested that manufacturers supply patient labeling, but where some manufacturers have failed to provide this information."

FDA pointed to benzodiazepine hypnotics and nonsedating antihistamines with boxed warnings as examples of classes of products for which medication guides will be required. In each of these classes, some manufacturers already provide patient labeling.

The agency continues to emphasize that the final rule will be very narrowly focused and does not represent an attempt to require patient-directed labeling for all products.

The final rule will apply only to products deemed to "pose a serious and significant public health concern," and medication guides will be required only in specific circumstances.

FDA's August 1995 proposed rule on medication guides originally included regulation of voluntary and mandatory patient information. However, a private-sector voluntary MedGuide program, codified by legislation in August 1996, stipulates that industry is to make patient information sheets available for 75% of products by the year 2000, and 95% of drugs by 2005.

The final rule does not apply to that voluntary effort and notes that "the agency is deleting the provisions of the proposed rule that dealt with the private sector voluntary program."

FDA has condensed the number of conditions under which medication guides would be required from four to three and has provided definitions of "serious risk" and "serious adverse effect" in order to "further narrow the scope of this regulation in response to many comments complaining of the breadth of the agency's proposed criteria for identifying products of 'serious and significant concern.'"

The final rule mandates that FDA must determine the information to be "'necessary' to patients' safe and effective use of the product" in order to require a medication guide. The agency maintains that "this is a high standard that will only be met in a small number of cases." Medication guides will be required for very few products, FDA suggested "on average no more than five to 10 products per year."

Although in its proposed rule FDA estimated that approximately 10 products a year would be affected by medication guide requirements, the agency indicates in the final rule that it "has determined that it initially overestimated the number of products or product classes per year that would be required to have a medication guide."

Under the rule, medication guides will be required for all products in a class deemed to present similar risks. In the rule, FDA asserts the agency's belief "that patients receiving similar medications, with similar risks, should receive similar approved patient labeling for all products in the specific pharmacologic class."

FDA emphasized products that already have patient-directed information as part of their approved labeling must continue to distribute the information.

"In time," the final rule states, "FDA intends to review all existing patient labeling to determine whether it is subject" to the rule. If patient-directed labeling is found to be required, the agency will notify sponsors directly, and "will allow them sufficient time to conform such labeling to the requirements of this final rule."

The rule addresses the issue of off-label drug use by requiring each medication guide to carry "the verbatim statement that 'medications are sometimes prescribed for purposes other than those listed in a medication guide,'" along with "a statement that the drug product should not be used for a condition other than for which it is prescribed," in order to avoid confusion.

The product's FDA-approved indication must be listed under the heading "What is [product name]?" In a change from the proposed rule, an explanation of the condition the product is intended to treat and benefits of treatment may also be included.

FDA has recently been preparing its own medication guides on the consumer drug information page of its website. The information sheets provide "basic information about medications recently approved by the FDA."

"MedGuides" Required Only In Classes Where Patient Info Already Requested

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