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Executive Summary

BETA-ADRENERGIC BRONCHODILATOR MDI OTC LABELING OPTIONS will be addressed by FDA's Pulmonary-Allergy Drugs Advisory Cmte. at its May 19-20 meeting in considering the suitability of the product class for OTC marketing. Noting that "labeling currently restricts bronchodilators in the OTC market to those patients with an established diagnosis of asthma who have mild disease for which they do not require prescription drugs and have never required hospitalization," FDA's prepared list of questions to the cmte. asks: "Are these restrictions adequate to assure appropriate patient use?" and "if not, what other labeling might provide better guidance to people who might want to avail themselves of an OTC product?" FDA is also asking for feedback on whether metered dose inhalers (MDIs) can be labeled for effective OTC use. For example, FDA is asking if patients "are likely to learn the technique of using an MDI from written instructions on the container?" and if "the information in labeling of OTC MDIs [can] be adequate education for patients?" In 1983, FDA's Pulmonary-Allergy Advisory Cmte. recommended that FDA rescind its 1982 decision to allow OTC marketing of metered dose metaproterenol. The cmte. had cited concern that because of FDA's lack of jurisdiction over OTC advertising, the products might be used in children even though metaproterenol is indicated for patients 12 and older. Opposition from the medical community was also a factor in FDA's decision to move the products back to Rx status. In recent comments to FDA, several professional assns. have expressed opposition to OTC status for metered dose bronchodilators. The American Pharmaceutical Assn. told FDA Com. Young in an April 10 letter that it is opposed to an Rx-to-OTC switch for the products unless a mechanism can be established for health professional monitoring, such as pharmacist dispensing during a transition period ("The Pink Sheet" April 28, In Brief). The American Academy of Pediatrics and the chairman of the American College of Allergists Therapeutics Cmte. have also submitted comments opposing a switch. The American Society of Hospital Pharmacists, referring specifically to metaproterenol products, told FDA the products should remain Rx unless the agency establishes a third class of drugs. Professional assns. scheduled to testify at the meeting include: the American Academy of Allergy and Immunology, the American College of Allergy, the American Pharmaceutical Assn., and the Proprietary Assn. P-A reported in its May 12 newsletter that it plans to ask FDA to make decisions on MDIs individually rather than as a class. The assn. staff met with representatives from member firms on May 16 to work out details of P-A's statement to the cmte. Also scheduled to testify at the meeting are Boehringer-Ingelheim, who manufactures Alupent MDI (metaproterenol), and Sterling, who manufactures Tornalate MDI (bitolterol mesylate). Boehringer Ingelheim filed a supplemental NDA in June to switch its bronchodilator from Rx-to-OTC. Sandoz, who also manufactures metaproterenol (Metaprel) is not scheduled to testify at the meeting.

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