FDA seeks public comment on albuterol metered dose inhalers containing ozone-depleting propellants

Jun 12 2004

FDA put on display today a Federal Register notice seeking public comment on a proposal for withdrawing "essential-use" status for albuterol metered-dose inhalers (MDIs) using chlorofluorocarbon (CFC) propellants. This notice is being issued because two alternatives, non-CFC-based, albuterol MDIs are now available. If the essential-use designation is removed, albuterol MDIs containing an ozone-depleting substance (ODS) could not be marketed after an appropriate transition period.

FDA has tentatively concluded that the two non-CFC based albuterol products will be satisfactory alternatives to the albuterol MDIs containing ODS. In today’s notice FDA is, among other things, soliciting comments on a number of issues including the effective date of the rule and the transition period.

CFCs have been commonly used as propellants for various pressurized products including MDI treatments for asthma and chronic obstructive pulmonary disease (COPD), which includes emphysema and chronic bronchitis. Since 1978, the use of CFC-emitting aerosol products in the United States has been generally banned because of increasing evidence that CFCs contribute to the depletion of the earth's protective ozone layer.

As a result of an international agreement established through the Montreal Protocol on Substances that Deplete the Ozone Layer and the U.S. Clean Air Act, CFC production and importation have also been banned for all commercial purposes in the United States since January 1996. The only exceptions to these bans are products that are considered medically essential with no suitable alternatives. Albuterol CFC-containing MDIs for asthma and COPD have been considered exceptions from the ban. However, under the Montreal Protocol and the Clean Air Act we are expected to phase out these products when suitable alternatives are available.

Although there are compelling reasons to phase out the use of these products, as a public health agency FDA must also weigh the potential public health impacts of such an action.

Under FDA regulations, to remove an essential-use designation, FDA must find that:

• At least one non-CFC product with the same active drug is marketed with the same route of administration, for the same indication, and with approximately the same level of convenience of use as the CFC product containing that active ingredient; (for drug moieties with more than one available CFC product, such as albuterol, more than one non-ozone depleting alternative must be marketed).
• Supplies and production capacity for the non-CFC product(s) exist or will exist at levels sufficient to meet patient needs;
• Adequate U.S. postmarketing use data are available for the non-CFC product(s); and
• Patients who are required to utilize the CFC product for medical reasons are adequately served by the alternative non-CFC product(s) and other available products.

The agency is providing a 60-day public comment period from date of publication on this matter. For additional information, go to: www.fda.gov