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| |  Asthma Group Objects To Proposed FDA Ban on CFC Metered Dose Inhalers FAIRFAX, Va., April 24 , 1997 -- Allergy and Asthma Network/Mothers of Asthmatics, Inc. today announced their opposition to proposals by the United States Food and Drug Administration (FDA) to eliminate metered dose inhalers that contain chloroflourocarbons (CFCs). In a statement, the group said the FDA’s proposals do not adequately meet the needs of patients who rely on the devices to treat breathing problems associated with asthma and other respiratory diseases. The Allergy and Asthma Network/Mothers of Asthmatics, Inc. is an international, nonprofit clearinghouse for asthma information. President Nancy Sander said proposed regulations fail to balance the medical needs of people with asthma with those of the environment. CFCs propel medication in aerosol inhalers, the mainstay of treatment for people with asthma. Production of CFCs, which deplete the ozone layer, was banned world wide in 1996, but the FDA granted an "essential use" exemption to the medical devices to allow drug manufacturers time to develop alternative products. According to the Only one new product has received FDA approval, but dozens more are expected by the year 2000. Consequently, the FDA is proposing changes to accommodate new medications and delivery systems while phasing out CFC inhalers. At a public hearing earlier this month, Sander told the FDA that its proposals for current devices limit therapeutic choices, place patients' health at risk and do not adequately monitor patients throughout the transition process. She presented the results of the group's national survey of asthma patients. "More than half of the survey respondents did not believe that the FDA proposals strike a balance that best protects their health while curtailing the release of an ozone-depleting substance," said Sander. The survey showed concern was higher among patients who suffered from moderate or severe asthma or had used their medication more than six years. Patients also said they wanted to use alternative inhalers at least a year before deciding if they can replace their current therapy. "This is a good opportunity for pharmaceutical companies to develop delivery systems and dosing options to improve asthma therapies," said Sander. "But the FDA must keep the patient's health as the top priority. Patients are genuinely worried about making safe transitions." The survey was sponsored by AAN/MA and was conducted with an unrestricted educational grant from Glaxo Wellcome Inc.
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