UPDATE ON METERED DOSE INHALERS THAT CONTAIN OZONE-DEPLETING PROPELLANTS

FDA has received many recent inquiries on the status of metered-dose inhalers (MDIs) for patients with asthma and chronic obstructive pulmonary disease (COPD) that contain chlorofluorocarbons (CFCs). The following can be used to answer questions:

1. The Advance Notice of Proposed Rulemaking (ANPR) that FDA published on March 5, 1997 does not alter the availability of CFC-containing MDIs for any patient with asthma, COPD or any other condition. FDA has repeatedly stated that it is premature to even propose a target date for the phase-out of the CFCs in MDIs. The purpose of the ANPR, which represents only the first stage of a multi-stage process, is to allow interested persons or groups to comment on a proposed phase-out strategy prior to the development of a proposed rule. FDA chose to use the ANPR notice to obtain the broadest possible public input on this matter from all relevant interest groups -- patients, physicians, industry, etc. FDA received thousands of comments on this ANPR, and it is currently carefully reviewing them. At each stage of the future rulemaking process, there will be ample opportunities for public comment.

2. Before determining the status of these medical products, FDA plans to take into account many practical health considerations -- such as whether there are an adequate number of safe and effective alternative products available to patients; how the available alternatives to CFC-based MDIs serve the needs of various patient subpopulations; how well are these alternatives accepted by patients; and whether there are adequate supplies of, and production capacity for, the alternative products.

3. Currently, there are already several inhaled asthma drugs that do not contain CFCs available to patients. Only one of these products, Proventil HFA, is an MDI propelled by a CFC-alternative -- hydrofluoroalkane (HFA). FDA anticipates that CFC-containing MDIs for asthma and COPD will not be phased out until there is an adequate number of safe and effective therapeutic alternatives available to meet the medical needs of patients. FDA anticipates that this array of available medical products will be as wide, if not wider, than what exists at the present time.