AARC Testifies Before FDA Committee

For Immediate Release
IRVING, TX (June 15, 2004) – The American Association for Respiratory Care (AARC) testified before an influential Food and Drug Administration (FDA) committee in early June, addressing issues surrounding the eventual phase out of chlorofluorocarbon (CFC) metered dose inhalers.

Key concerns shared by respiratory therapists nationwide include ensuring an uninterrupted supply of medications during the transition, keeping the transition as cost-neutral as possible for patients, and ensuring patients fully understand how to use the replacement inhalers, says Joseph Rau, PhD, RRT, FAARC, who presented the testimony before the FDA's Pulmonary-Allergy Drugs Advisory Committee on behalf of the AARC.

Dr. Rau explains CFC inhalers were initially exempted from the ban on CFCs required under the Montreal Protocol, an international agreement signed by the United States and other countries over the past decade to protect the ozone layer. The exemption was intended to give the pharmaceutical industry time to develop alternative products for the treatment of lung diseases.

“The advisory committee was discussing whether to end the exemption for use of CFC metered dose albuterol,” says Dr. Rau, who serves as chair of the cardiopulmonary sciences department at George State University. Given the availability of new, CFC-free inhalers, he says the AARC believes it is now time to move forward with the phase out.

Dr. Rau noted several alternative products are now available to replace CFC inhalers. For example, Proventil® HFA and Ventolin® HFA may be substituted for CFC albuterol MDIs, and Sepracor Pharmaceuticals has recently filed a new drug application (NDA) for Xopenex® HFA MDI (levalbuterol), another short-acting beta-2 agonist.

In keeping with the testimony presented by other groups and organizations at the meeting, Dr. Rau says the AARC is calling for a complete ban on CFC MDI albuterol by December 31, 2005. This date corresponds to the date when the last producer of pharmaceutical grade CFCs is scheduled to cease production.

Dr. Rau says the AARC believes phasing out the CFC products by this date is the best way to ensure replacement of CFC MDIs is driven by a planned, transparent timeframe agreed to by the FDA and pharmaceutical manufacturers, rather than dictated by the unavailability of CFCs .

Respiratory therapists are specially trained health care professionals who assist physicians in treating and managing respiratory patients in hospitals, outpatient centers, physicians' offices, skilled nursing facilities, and patients' homes.

The AARC is a professional membership organization of respiratory therapists dedicated to respiratory therapy education and research. Among its goals are to advocate on behalf of pulmonary patients for appropriate access to respiratory services provided by qualified professionals and to benefit respiratory health care providers.

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		AARC Testifies Before FDA Committee on Phase Out of CFC Inhalers For Immediate Release IRVING, TX (June 15, 2004) – The American Association for Respiratory Care (AARC) testified before an influential Food and Drug Administration (FDA) committee in early June, addressing issues surrounding the eventual phase out of chlorofluorocarbon (CFC) metered dose inhalers. Key concerns shared by respiratory therapists nationwide include ensuring an uninterrupted supply of medications during the transition, keeping the transition as cost-neutral as possible for patients, and ensuring patients fully understand how to use the replacement inhalers, says Joseph Rau, PhD, RRT, FAARC, who presented the testimony before the FDA's Pulmonary-Allergy Drugs Advisory Committee on behalf of the AARC. Dr. Rau explains CFC inhalers were initially exempted from the ban on CFCs required under the Montreal Protocol, an international agreement signed by the United States and other countries over the past decade to protect the ozone layer. The exemption was intended to give the pharmaceutical industry time to develop alternative products for the treatment of lung diseases. “The advisory committee was discussing whether to end the exemption for use of CFC metered dose albuterol,” says Dr. Rau, who serves as chair of the cardiopulmonary sciences department at George State University. Given the availability of new, CFC-free inhalers, he says the AARC believes it is now time to move forward with the phase out. Dr. Rau noted several alternative products are now available to replace CFC inhalers. For example, Proventil® HFA and Ventolin® HFA may be substituted for CFC albuterol MDIs, and Sepracor Pharmaceuticals has recently filed a new drug application (NDA) for Xopenex® HFA MDI (levalbuterol), another short-acting beta-2 agonist. In keeping with the testimony presented by other groups and organizations at the meeting, Dr. Rau says the AARC is calling for a complete ban on CFC MDI albuterol by December 31, 2005. This date corresponds to the date when the last producer of pharmaceutical grade CFCs is scheduled to cease production. Dr. Rau says the AARC believes phasing out the CFC products by this date is the best way to ensure replacement of CFC MDIs is driven by a planned, transparent timeframe agreed to by the FDA and pharmaceutical manufacturers, rather than dictated by the unavailability of CFCs . Respiratory therapists are specially trained health care professionals who assist physicians in treating and managing respiratory patients in hospitals, outpatient centers, physicians' offices, skilled nursing facilities, and patients' homes. The AARC is a professional membership organization of respiratory therapists dedicated to respiratory therapy education and research. Among its goals are to advocate on behalf of pulmonary patients for appropriate access to respiratory services provided by qualified professionals and to benefit respiratory health care providers. ### Contact: Kris Williams AARC Communications Manager (972) 406-4690, Williams@aarc.org

AARC Testifies Before FDA Committee on Phase Out of CFC Inhalers