August 24, 2007

The FDA is reviewing the "essential use" designation for seven Metered Dose Inhaler (MDI'S) drugs which they suggest should be phased out by December of 2009.  An FDA hearing took place August 2007 and the deadline to submit comments for this federal rule has been extended to September 30, 2007.

The Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) have jurisdiction over lessening the use of ozone-depleting substances (ODS) in pressurized containers called chlorofluorocarbon (CFC) propellants.  The Montreal Protocol and the Clean Air Act aim to transition away from all CFC containing products because of public health concerns.  There are exceptions for those CFC’s which are designated for “essential use” (defined as those substances that are necessary for health and safety or critical to the functioning of society and for which no alternatives exits).  Currently the only two oxygen depleting substances allowed in the United States for essential use are methyl chloroform for use in the space shuttle and Titan rocket, and CFC’s for seven metered-dose inhaler drugs.

We strongly support the goals of the Montreal Protocol and the provisions of the Clean Air Act and commend the American Lung Association and others who have advocated for the phase out of CFC containing products.  However, at this time no equivalent substitute for the MDI albuterol and ipratropium in combination (trade name Combivent), has been developed.  By removing Combivent from the essential use designation, approximately 2,000,000 COPD patients would be forced to obtain these drugs in two separate prescriptions, and perhaps make two co-payments to purchase, and use, two different delivery devices containing one medication each.  We do not hold that this is a reasonable substitute for Combivent which delivers both medications with one prescription and one delivery device.  To remove Combivent MDI from these patient's regimes, before an equivalent is available, will threaten their ability to function in everyday life and, in rare cases, be life-threatening.

Regardless of the reasons that a suitable formulation has not yet been developed, the fact remains that Combivent MDI is the mainstay of what is known as 'rescue medication' for many patients with COPD.  The company provided testimony to the FDA in August stating that a new non CFC delivery abluterol and ipratropium in combination would be ready to reach the US market by the forth quarter of 2010. 

The FDA has extended its deadline for regulatory comments on this issue to September 30, 2007.  At this time there is no suitable substitute for Combivent available. So please ask that the FDA extend the essential use designation for Combivent until December 2010.

Submit your comments and let your voice be heard.  You can make a difference! The deadline is September 30,2007 so don’t delay!

Your comments must contain the following information to be accepted by the FDA:
Docket No. 2006N-0454 and RIN number 0910-AF93
To submit comments electronically:

• Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for submitting comments.
•  Agency Web site: http://www.fda.gov/dockets/ecomments . Follow the instructions for submitting comments on the agency Web site.

For Written Submissions:
FAX: 301-827-6870
Mail/Hand delivery/Courier:
Divisions of Dockets Management (HFA-305),Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852