An adverse event statement may appear on drug product labeling before FDA can determine the best statement to apply.

A provision of the FDA Amendments Act would automatically finalize a proposed rule that mandates that drug labeling carry a statement suggesting patients report adverse events to FDA.

The statement, which will also recommend contacting a physician for medical attention, will accompany a toll-free number for reporting side effects as mandated by the Best Pharmaceuticals for Children Act (¹ [A#00660170038], p. 39).

FDA issued the proposed rule to require the phrase in 2004, but a final rule has been delayed in part due to concern about how best to present the information to avoid confusing patients. Under FDAAA, the proposed rule will become final on Jan. 1 unless the agency finalizes another one. (Over-the-counter drugs appear to be exempted from the congressionally activated rule as long as they include a reporting number for the manufacturer in the packaging.)

The agency will be hard pressed to finalize a rule on its own by the end of the year because it is ramping up an Internet survey to obtain feedback about which potential side effect statement would be the best one to use (² Also see "Adverse Event Reporting Hotline Being Refined Through FDA Labeling Study" - Pink Sheet, 12 February, 2007., p. 21).

FDA is testing five different side effects statements for prescription drugs and four for OTC products in a 1,600-person survey to evaluate "which side effects statements most effectively convey appropriate information to consumers," an Oct. 11 Federal Register notice says.

The rule's proposed language for the statement is "Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088."

FDAAA also directs a similar study to be conducted to determine whether the phrase "You are encouraged to report negative effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088" is appropriate for inclusion in televised DTC advertisements.

The legislation already requires the statement be included in print consumer ads.

- Brian Marson (b.marson@elsevier.com)

Side Effects? FDA May Require Adverse Event Hotline Even As Surveys Continue

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