FDA Is Considering Removal of CFC Inhalers

Published Online: Wednesday, September 1, 2004

The FDA has proposed gradually phasing out certain inhalers that pollute the environment, and the agency has asked asthma patients and physicians for comments on the matter. Older asthma inhalers use chlorofluorocarbons (CFCs) that deplete the ozone layer. An international treaty mandates that they be phased out, once suitable alternatives are available.

Currently, there are 2 CFC-free inhalers containing albuterol on the market?Proventil HFA and Ventolin HFA. Because albuterol can be lifesaving for patients with asthma and certain other lung diseases, the FDA wants public input to determine whether those 2 alternatives are adequate. One of the questions for the public to consider is whether CFC-free versions perform as well. Price and availability also are issues for consideration.

Proventil HFA and Ventolin HFA make up only 7% of the albuterol market, and production of these inhalers would have to increase. Also, they cost at least $10 more than generic albuterol inhalers, and generic CFC-free versions may not be feasible until 2010 or later, FDA officials said. The agency will make a final decision next summer on how quickly CFC-containing albuterol inhalers can be phased out.

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