FDA To Phase Out Asthma Inhalers With CFCs
By JENNIFER CORBETT DOOREN
March 31, 2005 3:49 p.m.
Of DOW JONES NEWSWIRES
WASHINGTON -- The Food and Drug Administration said Thursday that albuterol metered-dose inhalers using chlorofluorocarbon propellants, or CFCs, must no longer be produced, marketed or sold in the U.S. after Dec. 31, 2008.
Such inhalers are used to treat asthma, a condition in which the lung's main airway passages become inflamed. The decision was laid out in a final rule published in Thursday's Federal Register.
The use of CFCs have been banned in most consumer aerosol products since 1978. However they were allowed to remain in certain products for medical use like metered-dose inhalers. CFCs damage the earth's ozone layer, allowing more damaging radiation from the sun to reach the Earth's surface.
The FDA, and its parent agency the Department of Health and Human Services, said sufficient supplies of two approved, environmentally friendly albuterol inhalers by GlaxoSmithKline PLC (GSK) and Schering-Plough Corp. (SGP) will exist by the end of 2008 to allow the phasing out of similar less environmentally friendly versions. IVAX Corp. (IVX) also recently started making a CFC-free inhaler, FDA said.
The FDA said such inhalers generally cost about $20 more than ones containing CFCs and that they are "somewhat" different in their taste, delivery and feel because they do not all contain the same inactive ingredients. The agency recommended that consumers try the three alternatives on the market to find the product that works best for them.
The agency noted that the manufacturers of the CFC-free albuterol inhalers are implementing programs to help assure access to the newer products for patients for whom price could be a significant barrier. |
