T97-12 Susan Cruzan: (301) 443-3285 March 5, 1997 Jason Brodsky: (301) 827-3417 Consumer Hotline:(800) 532-4440 FDA SEEK PUBLIC COMMENT REGARDING METER DOSE INHALERS CONTAINING OZONE-DEPLETING PROPELLANTS FDA today published a notice in the Federal Register seeking public comment on a suggested approach for withdrawing "essential-use" status for products using chlorofluorocarbon (CFC) propellants. This notice is being issued because non-CFC- based, proven alternative aerosol medications are now available. Withdrawal of this status for these products would end their exemption from laws which prohibit CFC propellants. The following information can be used to answer questions: CFC has been commonly used as a propellant for various pressurized products including metered dose inhalant treatments for asthma, Chronic Obstructive Pulmonary Diseases (COPD) such as emphysema and other respiratory conditions. Since 1978, the use of CFC-emitting products in the United States has been sharply curtailed because of increasing evidence that CFC's contribute to the depletion of the earth's protective ozone layer. As a result of international agreement established through the Montreal Protocol on Ozone Depleting Substances (which the United States signed) and the U.S. Clean Air Act, CFC production -MORE- Page 2, T97-12, Meter Dose Inhalers and importation have been banned for all commercial purposes in the United States since January 1996. The only exceptions to this ban are products which are considered medically essential with no suitable alternatives, which include metered dose inhalers for asthma and COPD. These essential-use determinations are part of FDA regulations and are accepted under the Clean Air Act. In August 1996, FDA approved the first alternative propellant metered-dose-inhalers. With the advent of this product, and the promise of other alternative products becoming available in the future, FDA is now proposing a strategy for the future transition from CFC-based products to alternative aerosol delivery products. This notice outlines the proposed strategy for withdrawing "essential use" status for CFC-based products as proven alternative products meeting patient needs become widely available and accepted. The proposed strategy would require post-marketing data proving safety, efficacy and patient acceptance before a non-CFC based product could be considered to be an acceptable alternative. The agency is providing a 60-day public comment period on this matter. Written comments can be submitted to: Dockets Management Branch (HFA-305) Food and Drug Administration 12420 Parklawn Drive, Room 1-23 Rockville, MD 20857 ####