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Petitioning Environmental Protection Agency
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Environmental Protection Agency

Bring Back My Primatene® Mist

Primatene® Mist is an over-the-counter (OTC) inhaler for asthma patients that has been used safely by millions of people for more than 46 years to help them cope with asthma related symptoms including shortness of breath. It is manufactured by Armstrong Pharmaceuticals, Inc. which is a wholly-owned subsidiary of Amphastar Pharmaceuticals, Inc. There is currently no OTC inhaler for asthma patients available.

If someone without a prescription for an inhaler is suffering from asthma symptoms, they either need to go to the emergency room -- which can cost thousands of dollars -- or simply endure the pain and shortness of breath. 

The existing supply of Primatene® Mist inhalers (approximately 1 million units) expire in 2013, and the EPA has not granted permission for additional CFCs to be used to create additional inhalers.  If the EPA allows the current supply back on the market, it would only be until August 2013.

Amphastar/ Armstrong has received thousands of complaints and inquiries from people who used, benefited from and want continued access to the product. 

Amphastar has repeatedly asked for guidance from the EPA, and received no response, about how to dispose of the current supply of Primatene® Mist inhalers without releasing the CFCs into atmosphere. It is better to allow the approximately 1 million currently available units be made available to help people suffering from asthma, rather than to waste them and still have the CFCs escape into the environment.

There are prescription inhalers still on the market which contain CFCs and they are being used by asthma sufferers.  It is difficult to understand why some prescription inhalers containing CFCs are still allowed to be sold, whereas Primatene® Mist, which was the only OTC inhaler, has been banned. 

 

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Letter to
Environmental Protection Agency
request that the Environmental Protection Agency (EPA) immediately take steps to put Primatene Mist back on store shelves.

When the EPA banned Primatene Mist for sale at the end of 2011, it took away the only over-the-counter inhaler to help asthmatics and COPD sufferers cope with their symptoms including shortness of breath.

Without Primatene Mist, Americans lacking health insurance or the means to afford a doctor's visit and costly prescription inhalers either need to go to the emergency room -- which can cost thousands of dollars -- or simply endure the pain and shortness of breath. Neither is acceptable.

The EPA claims it banned the inhaler because it contains chlorofluorocarbons (CFCs), which could contribute to global warming. However, the EPA allows the sale of some prescription inhalers which contain CFCs. The EPA also has no idea how to dispose of the existing Primatene Mist inhalers without letting those CFCs escape into the environment. For both of these reasons, the EPA's decision to block the sale of the approximately one million Primatene Mists collecting dust on warehouse shelves goes against common sense.

Notably, the company which makes Primatene Mist has promised to donate all the net profits from the sale of Primatene Mist to charity, which could total in the millions.

The EPA should do the right thing and put Primatene Mist back on the market immediately. Protecting the environment is important -- but it should not come at the cost of the health of millions of asthma and COPD sufferers.

(Photo by David McNew, Getty Images)