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| |  FDA and EPA Phase Out CFCs in Asthma Inhalers ST. PAUL, Minn., March 6, 1997 -- In an unprecedented collaboration to protect public health, the United States Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) announced a suggested approach that will phase out chlorofluorocarbons (CFCs) used in metered dose inhalers (MDIs). The FDA sets out the approach in the Advanced Notice for Proposed Rulemaking, published today. MDIs, used for over 40 years by asthma and other respiratory disease sufferers, have traditionally contained CFCs. CFCs have been shown to contribute to the destruction of the ozone layer. The FDA states, "An increase in ultraviolet radiation will increase the incidence of skin cancer, and produce other adverse effects of unknown magnitude on humans, animals, and plants." Previously, CFC-containing MDIs were exempt from the ban on CFCs until alternatives could be developed. In the document released today, the FDA and EPA recognized the obligation of the U.S., as a signatory to the Montreal Protocol, to eliminate this last remaining commercial use of CFCs. Many other countries, including the European Union, Latin America, Australia and Canada, also are developing similar approaches to phase out CFC-containing metered dose inhalers as alternatives become available. In responding to the U.S. FDA proposal, Fran DuMelle, deputy director, American Lung Association, commented, "We applaud the FDA's proposal because it continues to provide asthma patients with choices as we move forward on the successful introduction of CFC-free inhalers." Fortunately for patients and public health, many new and improved technologies are coming to the market as a result of this environmental mandate. For example, 3M has successfully introduced the first CFC-free metered dose inhaler, called Proventil-HFA(R), which is distributed by Schering-Plough in the United States. Outside of the United States, 3M's product, which contains the drug salbutamol, a common asthma drug, is approved in over 35 countries and is called Airomir(TM). 3M is making its CFC-free technology available to other companies and is currently working with seven companies on 11 different CFC-free drug formulations. Other companies also are developing dry-powdered inhalers and other non-CFC technologies. The FDA believes that this approach will "assist the FDA in striking an appropriate balance that will best protect the public health, both by ensuring the availability of an adequate number of treatment alternatives and by curtailing the release of ozone-depleting substances."
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