Dr. Burgess' Op-Ed: EPA could waive ban on Primatene Mist inhalers for asthmatics
EPA could waive ban on Primatene Mist inhalers for asthmatics
Posted by Meredith Smiley on November 13, 2012
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Washington
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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.
Comments
The opinions expressed below are those of their respective authors and do not necessarily represent those of this office.
  • Anna from Danielsville commented on 11/14/2012
    I used Primatene for over 40 years and now find myself having great difficulty without it. I was recently in the ER, which hadn't happened in over 8 years, with a severe asthma attack, and I truly believe that if I had had my Primatene my attack would not have gotten so out of control. The prescription inhalers do not work for me and I am very concerned that I will spend the rest of my life worrying about my breathing. Please bring back Primatene
  • Bruce Ward from Santa Maria commented on 3/19/2013
    What else is there to say "PLEASE LET ME BREATH...I NEED PRIMATENE MIST!!!!
  • Vinny Distefano from Orlando, FL commented on 3/19/2013
    Around age 16 I began having asthma attacks. I soon found relief from Primatene Mist(s). I was able to be active in school and later, at work. Until the ban, I have used it without incident. I am now 62. I am self employed and without health insurance. I cannot just walk into a doctors office and proclaim I have asthma and get a prescription. It will involve test after test and then a costly prescription. Last year, I could simply go to my local drug store and purchase a $20 medication that was effective. Primatene has proved it's worth for nearly half a century. It's time for the EPA got get the remaining Primatene back on the market and approve it's replacement. This is literally life and death.
  • Chris Conway from Jupiter, Florida commented on 3/19/2013
    Having spent 15 years in Washington DC covering Capital Hill and the White House for one of the major news networks, and having seen what goes on behind the scenes, I suspect the problem stems from the companies that produce prescription inhalers. I was trained to always follow the money whenever something that makes sense was held up. I submit lobbyists from Big Pharma have gotten to the administration. The banning of Primatene mist was a gigantic monetary windfall for these companies and I'm sure they are sparing no expense to keep it off the market. They have apparently even had a campaign to mis-educate doctors, convincing them that there is something inherently dangerous with using epinephrine. Nothing could be farther from the truth. When used as directed Primatene mist is actually safer than any of the prescription inhalers. The supposed reason for not allowing a waiver is because of the CFC propellant used in the inhaler. One 2 1/2 ton home air conditioner contains more CFCs than a lifetime supply of Primatene mist. Air conditioners spring leaks all the time and each time many pounds of CFCs are released into the atmosphere. The average home air conditioner loses and then has replaced it's entire load of CFCs six times before the unit is replaced with a non-CFC unit. The amount of CFCs in all the Primatene mist inhalers currently in the warehouse is a tiny fraction of the amount of CFCs released by air conditioners each year. The FDA is acting solely in the interest of Big Pharma. A waiver is way past due. Chris Conway
  • Tammy from Hurst Texas commented on 3/19/2013
    It is nuts that we don't have this available. The only solution that is available is thru prescription and name brand only...resulting in a high copay for most of us.....being that our paychecks and payroll have dropped dramatically, higher copays and deductibles to go to the doctor's office and for prescription drugs, this is really sad that we are not allowed to get one of these for emergencies. As long as Big Pharma is allowed to run the country, the only people who are suffering and dying as a result is we the people.....this needs to be stopped now...we need Primatene!
  • Dave Mayrose from Keller, Tx commented on 3/19/2013
    great! I bought a couple of extra before the ban went into effect. I still have them, but not sure what I am going to do when they run out. Thanks for doing this!
  • Margaret Savannah from Beachwood Ave commented on 3/19/2013
    I am 65 YR old woman,who has used Primatene Mist for over 45 yrs with absolutely no side effects.I find it amazing that with all the bs going on in the world you found the time to ban this inhaler.If the concern is so much about the environment why dont you go after the Pelosis and the Gores and their ilk for their use of private jets and huge suvs.Such hypocrites.This inhaler saves me going to the emergency room or the Doctors office which would cost a lot more,not too mention the fact that I can still work.I think its time people who elect these officials were listened to instead of the Government deciding what is and is not good for me.I didnt expect a caregiver when I voted,I expected elected officials to listen to what the voters want.
  • Rick from Candler,NC commented on 3/19/2013
    Release the remaining Primatene Mist, we are people with families, children, and grandchildren. We want to enjoy the same quality of life as you do, have fun with our children and grandchildren, not sit and worry if our next breathe will be our last. The FDA and Big Pharma have no idea what-so-ever how bad it is to breathe with asthma when all that has to be done is give us, the people and voters, our Primatene Mist back so we can enjoy life as we did before the ban. I believe all they do is sit on their backside and laugh about how many people they can get to beg for there medication. Go ahead FDA and prove me wrong, release the stockpile to the people and pass the new HFA version of Primatene, or don't and we will keep thinking about what kind of heartless monsters you are for letting people suffocate to death. My name is Rick and I approve this message.
  • Jeanie Russell from Baton Rouge commented on 3/20/2013
    I have used Primatene Mist since I was a child for seasonal flare-ups of asthma. I have never experienced one side effect and in many cases it has saved me. I do not have health insurance and I cannot afford an Emergency Room visit when I wake up and can't breathe properly. Upon using PM I was back to normal and able to sleep. I feel that the EPA and FDA are playing politics with my health. I do not want an inhaler pumped full of steroids and I feel it is an infringement on my civil rights to suddenly ban a product that has been readily available for so many years. Please bring back our Primatene Mist.
  • Dana Price from Delhi, Ca commented on 3/21/2013
    I just had to assemble and attempt to use this Asthmanepherine that replaced Primatene Mist. NO NO NO!!! This is not good when I need it fast. God please I've been praying these people who are keeping Primatene Mist away from us will please find their heart and not make us suffer like this. Please please bring back Primatene Mist so I can breathe again. I'm scared!
  • robert white from tallahassee fl commented on 3/27/2013
    As a taxpaying asthmatic i demand you in washington to stop holding all of us that cannot breath hostage. The primitine mist should have been medically exempt from the treaty/cfc ban. Mexico still makes R134... if you are so naive to think a bunch of people using small inhalers is doing any damage to the ozone...rethink what all the hot air does comming from washington...sad day you let people die who could not get any other form of cheap fast relief. Armstrong labs is just as much to blame as they should have had the forsite to have a fix ready to go and the EPA should have helped them get it. You all should be ashamed of the way you act. Im weezing as i type this. Sad sad sad.... thanks to dr. Mike maybe we have hope...
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