fda padac open public hearing regarding the possible removal of the essential use designation of...
TRANSCRIPT
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 [email protected] 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