The EPA Strikes Again

PrimateneMist is an over-the-counter (OTC) inhaler that has been used safely by millions of people for more than 46 years to help them cope with their asthma. It was the only OTC inhaler available to the public before it was banned for sale by the Environmental Protection Agency (EPA), on January 1, 2012. The EPA banned the inhaler to comply with yet another international treaty — in this case, the Montreal Protocol on Substances that Deplete the Ozone Layer. This treaty determined that CFCs, otherwise known as chlorofluorocarbons, damage the ozone layer and should be outlawed.

CFCs help propel the Primatene Mist into a person’s lungs, and this is where it gets interesting. In November 2008, when the EPA instituted the ban, it was assumed that a replacement OTC inhaler would be available for purchase at drug stores, grocery stores, and convenience stores by the beginning of 2012. They were mistaken. Today, there is still no OTC emergency inhaler available for the two to three million people who regularly used Primatene Mist before the ban.

There are typically two kinds of Primatene Mist users. The first category consists of people who do not have access to prescription inhalers because they lack health insurance or cannot afford a doctor’s visit to get a prescription. The second category consists of people who have health insurance, but prefer Primatene Mist. People in this category believe that PrimateneMist is the most effective inhaler to treat their symptoms or simply prefer PrimateneMist to prescription inhalers. While their reasons for using this type of inhaler may be different, the one thing that the two categories have in common is the denial of access to Primatene Mist, due to the Federal government’s lack of foresight.

As the mother of two asthmatic children, I take issue with an EPA decision that leads to an intrusion on my life and negatively impacts my ability to make the best decisions for my children.  Without the OTC option, families and adults must go to a physician and get a prescription inhaler.  Given the proposed changes to our healthcare system, do we really need another reason to go to the doctor and deal with our healthcare bureaucracy?

My family also suffers from seasonal allergies. While there are a variety of effective prescription drugs available, we prefer the OTC medications. They are cheaper than prescriptions; I can purchase them at wholesale clubs; and most importantly, they do not require a pediatrician appointment and a follow-up trip to the drugstore.  In other words, they provide me with options – something the EPA has eliminated by taking Primatene Mist off the shelves.

Since the Primatene Mist ban, the company that makes the OTC emergency inhaler, Amphastar, has received thousands of complaints and inquiries from people who used the inhaler and want it back on the market.  Today, there are approximately 1.2 million Primatene Mist OTC inhalers sitting in warehouses. Nevertheless, the EPA has rejected offers by Amphastar to put these inhalers back in stores. Unwilling to sit back and let these inhalers collect dust, Amphastar is fighting to get Primatene Mist back on store shelves and guaranteeing that all profits from the sale of the inhaler will be donated to charity.  They have also launched a petition and Facebook campaign to encourage the EPA to put the remaining supply of OTC inhalers back on the market and support federal legislation which would do the same thing.

The environmentalists can continue their debate about the ozone layer, but I am more concerned about access to affordable and readily available inhalers and prefer that this decision is not made by a bureaucrat sitting in a windowless office in Washington, DC.  The EPA showed a lack of foresight when they banned this product. But rather than do the right thing, and reverse course, the EPA is refusing to budge.  This is unfortunate because the real losers are consumers who want the freedom to choose for themselves and their family the best course of treatment for their asthma.

Cherylyn Harley LeBon is a lawyer, mother, and former Senior Counsel on the U.S. Senate Judiciary Committee.