FDA Regulations On Ozone Depleting Drugs Will Impact Availability Of Combivent

Main Category: Respiratory / Asthma
Also Included In: Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals;  Water - Air Quality / Agriculture
Article Date: 29 Aug 2007 - 2:00 PDT

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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.

The FDA is reviewing the "essential use" designation for seven Metered Dose Inhaler (MDI) drugs which they suggest should be phased out by December of 2009. One of the medications is recommended for removal from the essential list is Combivent. There is no equivalent substitute for Combivent at this time (but there should be by 2010, but not 2009 ).

By removing Combivent from the essential use designation, approximately 2,000,000 COPD patients would be forced to obtain drugs in two separate prescriptions, and perhaps make two co-payments to purchase, and use, two different delivery devices containing one medication each to achieve the same clinical result as with Combivent.

The AARC supports the provisions of the Montreal Protocols and the Clean Air Act, and we support the phase out of ozone depleting drugs, but only when there is a true substitute that will not impact the patient. The AARC submitted comments to the FDA on this issue.

American Association for Respiratory Care