FDA AMENDS TFM FOR OTC STOMACH DISCOMFORT DRUGS

The FDA issued a proposed rule Jan. 5 to amend the tentative final monograph (TFM) for OTC drugs that are used to relieve symptoms associated with overindulgence of food and drink to include new indications for products containing bismuth subsalicylate.

The proposed changes to the TFM would allow manufacturers to include the symptoms "belching" and "gas" in the labeling on stomach discomfort treatments containing bismuth subsalicylate as an active ingredient.

Previously, manufacturers could only state in their labeling that such products were intended for "upset stomach due to overindulgence in food and drink." The FDA said it drafted the amendments based on an analysis of comments and data that were received in response to the TFM.

The FDA issues TFMs as a routine portion of the second phase of its OTC drug oversight, according to the agency's website. After the first phase of the OTC drug review process is completed, and advisory review panels within the agency have reviewed the ingredients in the nonprescription drug product to determine they are safe and effective for self-treatment, the agency moves to the TFM stage. After the FDA issues the TFM, the public has a period of time to respond to the agency's proposal before the publication of a final drug monograph.

The FDA will accept comments on this proposed rule until April 15. To view a copy of the proposal, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/05-154.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/05-154.pdf).