FDA PADAC Open Public Hearing regarding the possible removal of the essential use designation of albuterol Comments of the American College of Allergy, Asthma and Immunology Delivered by Dr. Ira Finegold June 10, 2004

Eliminating CFC-containing MDIs… important for: ozone layer recovery improving patient outcomes protecting patients

As we understand CFC supply… Honeywell’s Dutch manufacturing plant is closing December 31, 2005 Honeywell’s Baton Rouge facility has yet to be “certified” by FDA Recommissioning Honeywell’s Baton Rouge facility may violate the Montreal Protocol and the Clean Air Act Annual Decisions of the Montreal Protocol Parties steadily signal international intent to close the treaty’s essential use exemption as alternatives are proven acceptable European Community, Australia, Canada and Japan all meeting internationally-agreed timelines

College supports… near-term phaseout of CFC-containing albuterol “as soon as is feasible” when can manufacturers meet demand? December 31, 2005 effective date is reasonable given two acceptable alternatives uncertainty of future CFC supply given finite supply

Cost of transition… Cost of transition cannot be ignored Costs can be addressed through competition certainty communication