| Home | Phase-out of CFC inhalers worries some patientsposted 5-14-97 In order to comply with a 10-year-old global treaty, Food and Drug Administration (FDA) officials recently announced plans for phasing out the use of asthma inhalers made with chlorofluorocarbon gases (CFCs) and for replacing them with new environment-friendly models. Although FDA officials say the switch will occur slowly and safely, the announcement sparked concerns among the estimated 24 million Americans with asthma or other respiratory problems who rely on inhalers. The plan to overhaul standard inhaler devices has been in the works since 1987, when more than 150 countries signed the Montreal Protocol treaty to reduce CFC levels worldwide. CFC pollution eats away the protective ozone layer in the Earth’s stratosphere that blocks cancer-causing ultraviolet radiation. The treaty granted only a temporary exemption for about 70 products called metered-dose-inhalers, which use CFCs to deliver a precisely measured mist of medication that is inhaled from a mouthpiece into the lungs. Although the amount of ozone damage linked to inhalers is minor, environmental experts warned that an ongoing exemption for the devices and other products on a global scale could delay ozone recovery. Drug companies have already spent $1 billion on the project and expect to double or triple that figure in the next few years. Experts estimate that up to 30 non-CFC inhalers will be on the market by 2000, but only one, Proventil HFA, is available now. The inhaler, which was introduced in January, uses a different gas propellant and contains albuterol, a common asthma drug. The new device costs about $25, nearly $7 more than the generic form of the drug. Medical experts say that the transition can be made without causing problems, but some worry that patients will absorb high costs down the road. Some patients expressed concern that, because of costs, a few drugs would not be reformulated into new inhalers. According to the advance draft of the FDA proposal, the phaseout of CFC inhalers will take years to complete. The agency said that no individual products will be eliminated until reliable replacements are available for one year, and with adequate supplies and production. An entire class of inhalers will be phased out only when three distinct alternatives become available. The FDA will further outline strategy in a formal "proposed rule," due out this month. A public comment period and a "final rule" will follow. Related Site
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