DeMint Amendment (#763) on FDA and Inhalers

• The amendment would prohibit the use of funds for the Food and Drug Administration to implement the final rule banning the production or sale of over-the-counter epinephrine inhalers containing chlorofluorocarbons, scheduled to take effect in January 2012.

• The Montreal Protocol on Substances that Deplete the Ozone Layer, an international treaty that went into force in 1989, required the phase-out of chlorofluorocarbons (CFCs) by 1996.  In general, the U.S. began phasing out the use of CFCs in consumer products in the 1970’s, and has banned the production of CFCs since 1996 — except for certain limited uses, such as metered-dose inhalers.
  
• In November 2008, the FDA, in conjunction with the EPA, stated that the phase-out for CFCs in over-the-counter inhalers would occur at the end of 2011.
  
• A recent FDA announcement on this issue noted that there is currently no epinephrine inhaler that uses the environmentally-friendly alternative to CFCs, meaning that the over-the-counter epinephrine inhalers (currently marketed as Primatene Mist) for relief of mild asthma will not be made or sold as of the end of the year.
  
• FDA also notes that “there are…many other safe and effective inhalers to treat asthma symptoms” other than over-the-counter epinephrine inhalers using CFCs.  However, these substitutes may be more costly, and may require a prescription.
  

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