EPA could waive ban on Primatene Mist inhalers for asthmatics
By Congressman Michael C. Burgess, M.D.
Dr. Burgess’ Op-Ed was published on The Hill’s website November 13, 2012

For years I have used a common over-the-counter emergency asthma inhaler called Primatene Mist. Like many asthma sufferers who find themselves awake at 2am with an unexpected asthma attack and do not have immediate access to an inhaler, Primatene Mist has been a simple and safe solution to what would otherwise be a costly and time-consuming emergency room visit. Unfortunately this past January, Primatene Mist was forced off pharmacy shelves due to an international treaty agreement known as the Montreal Protocol.

When the ban on Primatene Mist went into effect, people expected that its replacement would be available, without disruption. This was not the case. Although a replacement inhaler has been before the Food and Drug Administration’s (FDA) approval board for several years, there has been no action. This means that asthmatics currently have no over-the-counter remedy if they are faced with an emergency attack. This is especially dangerous if that attack happens when they are traveling and do not have their regular medicines handy.
 
The good news is that there is a simple solution. The Environmental Protection Agency (EPA) has within its authority the ability to waive the ban on Primatene Mist. By doing this, the existing stock that has already been manufactured would be available to be sold until a replacement can be approved.  This would provide the temporary solution asthmatics need.
 
Despite multiple letters to the EPA and President Obama, and repeated questions during committee hearings, they remain unresponsive. Why does the EPA refuse to grant a waiver for the small amount of existing stock to be made available to consumers – especially given that the product is no longer manufactured and will expire in just over a year? Ask them, because they sure haven’t told me.
 
Currently, there are over 1 million units of Primatene Mist inhalers sitting in a warehouse in California. It’s unconscionable to allow them to continue to sit, gathering dust, when they could be used to provide relief. Politicians spend a lot of time talking about how much they care about the plight of asthmatics and patients generally, and decrying the high costs of health care. Why then is the Obama Administration blocking a safe, effective, and inexpensive treatment option for patients suffering from an asthma attack – and one that has been in use for over 50 years? President Obama’s  lack of response is unexplained and indefensible.
 
I’ve heard from people all over the country asking that Primatene Mist be allowed to continue to be sold until a replacement is available. “It is cruel that EPA and FDA have absolutely no concept of how awful it is to have asthma and no over-the-counter inhaler anymore,” stated one patient from New Jersey. Another patient from my home state of Texas said it best: “Please don't make us beg for air, it’s not fair. It would only take one asthma attack for anyone that voted for this ban to change their vote. Trust me, it’s a horrible feeling to gasp for air.”
 
The miniscule amount of chlorofluorocarbons that exist in Primatene Mist will have negligible effects on our ozone, especially considering the limited supply left. The EPA should be on the side of patients and consumers. In this case, it is not. Lisa Jackson and President Obama need to stop this senseless war on asthmatics.
 
Burgess, a physician, is vice chairman of the House Energy and Commerce Committee’s Subcommittee on Health and chairman of the Congressional Health Caucus.