Regulatory Focus™ > News Articles > Environmental Regulations to Soon Force Two Asthma Products off Market

Environmental Regulations to Soon Force Two Asthma Products off Market

Posted 30 May 2013 | By Alexander Gaffney, RAC 

A new missive to US consumers from the US Food and Drug Administration (FDA) warns them that, after a lengthy series of delays, they should prepare for the removal of the final two asthma inhalers containing chloroflurocarbon (CFC)-based propellants as of August 2013.

Background

The removal of the inhalers from the market has long been planned and has almost as long been a source of contention, particularly among some prominent legislators with authority over FDA.

The entire matter stems from the an environmental protocol signed by the US in 1987 known as the Montreal Protocol, an international agreement meant to preserve the ozone layer-which CFCs are particularly adept at destroying-by phasing out the use of CFCs, which were then commonly used as propellants in aerosol canisters.

Despite the Protocol's phase-out plan, it took until 2006 for the US Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) to develop rules to implement the CFC phase-out.

By 2008, both EPA and FDA's attempts to get all manufacturers to switch to different propellants had failed, with at least one-Amphastar, manufacturer of Primatene-underwriting a lobbying campaign against the proposed ban. Critics contended the amount of CFCs emitted by the products were insignificant and would be of no consequence to the ozone layer. Those arguments lost out, and on 1 January 2012, FDA finally acted to ban the products from the market.

Some legislators have moved in recent years to delay the implementation of the ban. Rep. Michael Burgess (R-TX) introduced the Asthma Inhalers Relief Act (the AIR Act) in 2012, which would have delayed implementation until August 2013. That law has not passed either house of Congress despite Burgess' repeated efforts and pleas.

Last Two to be Removed from Market

Now FDA is warning consumers that the last two inhalers that contain CFCs-Combivent Inhalation Aerosol and the Maxair Autoinhalar, both prescription products-will be unavailable as of August 2012 and January 2014, respectively.

FDA notes that albuterol inhalers, the most common type used to treat asthma, were removed from the market in 2008 and replaced with a hydrofluoroalkanes (HFA)-based propellant. Combivent had an alternative approved in 2011 that contains the same active ingredients but does not contain the CFCs. Alternatives to Maxair include albuterol or levalbuterol, FDA said.

Burgess, however, notes that there is still no approved substitute for Primatene, an OTC asthma inhaler. FDA has advised these patients to obtain a prescription for albuterol or other FDA-approved prescription asthma management products, which it acknowledges will likely cost consumers a greater amount of money, even before the cost of a visit to a doctor is factored in.


FDA: Users of Last CFC Inhalers Must Soon Switch


Tags: Asthma, Inhaler

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