Today, I represent a California company that has over one million potentially life-saving inhalers just sitting in a warehouse. These inhalers could help millions of asthma sufferers in the United States who lack the financial means to afford health insurance and costly prescription inhalers, but they are collecting dust because at the end of 2011, the government banned Primatene Mist, the only over-the-counter inhaler sold at grocery and drug stores. Prior to the ban, Primatene Mist had been safely helping people deal with their breathing issues for over 46 years.
Primatene Mist was banned because it contains chemicals known as chlorofluorocarbons (CFCs). The Environmental Protection Agency (EPA) claims to be imposing this ban in accordance with a treaty signed in 1987, which determined that CFCs were damaging the ozone layer and should be discontinued. The EPA could make an exception for Primatene Mist but has decided against doing so.
Amphastar, the company which makes Primatene Mist, finds the decision to put environmental concerns over the health of asthmatics unacceptable. So the company is launching a petition encouraging the EPA to reverse course on their decision to ban Primatene Mist.
The company has also decided that if it can place the inhalers back on the market, all the net profits from the sale of Primatene Mist will be donated to charity. Amphastar is doing this because it wants the EPA to understand that this effort to put Primatene Mist back on store shelves is not about making money. Rather, it is about helping the millions of Americans that used to rely on the over-the-counter inhaler. With around one million units still available for sale, each of which returns the company a net profit of around $6.50, Amphastar is looking at the possibility of donating millions of dollars to worthy causes.
The decision to challenge the EPA also stems from Amphastar's concerns with the Agency's rationale for not allowing Primatene Mist back on the market.
First, the EPA has allowed other inhalers containing CFCs to be sold. These inhalers are prescription strength and effective in the treatment of asthma. But because they require a prescription, they are out of reach for the millions of Americans lacking health insurance and the means to pay for a doctor's visit and costly inhalers. The government is requiring a treatment for asthma that millions of Americans simply cannot afford.
Second, the government has no idea how to safely dispose of the remaining Primatene Mist inhalers. Since any CFCs in the inhaler are going to end up in the environment no matter what, shouldn't they at least be put to good use by helping people cope with their asthma symptoms? This seems like common sense, but the EPA has repeatedly denied any plan to put Primatene Mist back on store shelves.
To remedy the EPA's unwillingness to bend on Primatene Mist, two bills have been introduced in Congress which would put the inhaler back on store shelves despite EPA's concerns. Hopefully this legislation will pass the Congress and become law. In fact, in the House, this legislation is scheduled to be marked-up this week.
To be honest, before the ban was implemented at the end of last year, I thought that the EPA would realize that not having an inhaler available over-the-counter was a serious health concern and would allow Amphastar to sell Primatene Mist until a replacement inhaler was available. I was wrong. I hope that the EPA will now use common sense and reverse course immediately; doing so could save lives and reduce human suffering associated with the symptoms of asthma.
Former Congressman Stupak is the lobbyist for the company (Amphastar Pharmaceuticals) that makes Primatene Mist.