Regulatory Focus™ > News Articles > OTC Asthma Inhaler Prepares to Return to Market, Years After Being Pulled for Environmental Problems

OTC Asthma Inhaler Prepares to Return to Market, Years After Being Pulled for Environmental Problems

Posted 07 January 2014 | By Alexander Gaffney, RAC

A just-announced advisory committee set to meet in February 2014 may bring US regulators one step closer to alleviating a major shortage of asthma medication that resulted from the implementation of long-planned environmental regulations banning certain types of aerosol propellants.


In 1987, the US signed an environmental agreement known as the Montreal Protocol, an international agreement meant to preserve the ozone layer by phasing out the use of chloroflurocarbons (CFCs), which were then commonly used as propellants in aerosol canisters, including asthma inhalers.

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.

While some legislators worked to overturn or delay the ban, those efforts ultimately failed, and FDA moved to remove the last of the inhalers from the market in August 2013.

Focus on Primatene Mist

While the last two products removed were prescription products, Combivent Inhalation Aerosol and the Maxair Autoinhalar, much of the CFC controversy had instead focused on Amphastar's Primatene Mist, which was available to consumers over-the-counter (OTC). The drug was the only OTC asthma medication sold in the US.

Some consumers found this to be advantageous, as it allowed them to avoid a costly doctor's visit every time they needed a refill on an asthma inhaler.

At the time of Primatene's removal from the market in 2012, the drug had no approved substitute.

That situation, however, may soon change.

FDA has announced that its Pulmonary-Allergy Drugs Advisory Committee (PADAC) is set to meet on 25 February 2013 to discuss an application filed by Armstrong Pharmaceuticals-also known as Amphastar-to market epinephrine inhalation aerosol 125 mg under the trade name Primatene HFA.

Like Primatene mist, it would be available to consumers OTC, and the Federal Register notice specifically refers to it as a "replacement for Primatene Mist."

PADAC, FDA said, "Will be asked to consider whether the data support an acceptable risk/benefit profile of the epinephrine inhaler for use by OTC consumers."

Additional materials will be available at least two business days prior to the start of the meeting.

FDA Meeting Notice

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