[Congressional Record Volume 143, Number 95 (Tuesday, July 8, 1997)]
[House]
[Pages H4839-H4840]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




      FDA AND EPA SHOULD POSTPONE ACTION AFFECTING ASTHMA PATIENTS

  Mr. STEARNS. Mr. Speaker, I rise today to bring our colleagues' 
attention to the FDA's proposed policy that would deny asthma patients 
the medicines they need to help them breathe. I and the gentleman from 
New Jersey

[[Page H4840]]

[Mr. Smith] expect to propose a resolution urging the FDA and the EPA 
to postpone action on this matter.
  Mr. Speaker, 30 million people in the United States today rely on 
these medications and as each of us know, some better than others, 
these people use a product called a metered dose inhaler, which I will 
refer to as MDI, to deliver the medications they need into their lungs. 
Over the past 25 years, we have developed many new treatments for 
people with asthma, chronic pulmonary disease, and other airway 
diseases that prevent people from breathing. In fact, there are now 70 
different products available in metered dose inhalers. For people who 
cannot breathe, these products are lifesavers and allow people to lead 
normal lives.
  On March 6, 1997, the Food and Drug Administration surprisingly 
issued an advance notice of proposed rulemaking that sets in motion a 
process to take these medications away from patients. According to the 
FDA, this proposed rule was developed in collaboration with the 
Environmental Protection Agency because of EPA's desire to eliminate 
all uses of chlorofluorocarbons. These are what are called CFC's, which 
I will refer to them as.
  CFC's are important in this picture because all metered dose 
inhalers, except one, use CFC's, a propellant that gets the medicine 
from the inhaler canister into the patients' lungs. Until recently, 
CFC's were the only propellant approved by the FDA to do so.
  I am told the makers of metered dose inhalers believe that 
elimination of CFC's is a worthy goal. Therefore, that is why the 
United States and 140 other countries signed a treaty to phase out 
CFC's use. I believe this treaty did a good job establishing a process 
that allows companies that make products that use CFC's to develop 
alternatives and get these to the customers.
  The treaty went for the big users of CFC's first. In the United 
States we no longer use CFC's in hair sprays, air fresheners, new cars 
containing air-conditioning systems, and new refrigerators. Some of us 
here in the House may question this altogether, but it is done.
  The treaty, however, also acknowledged that some uses were more 
difficult to phase out. Asthma medicines were one of them. So why is 
the FDA now proposing action that would unnecessarily move up the time 
line provided in this international treaty? Why, when FDA's mission is 
to provide patients with safe and effective medicines, is it seeking to 
ban the safe and effective medicines from patients who require them?
  Thousands of Americans fear this proposed policy. I am keenly aware 
of the fear my constituents have. A woman in Ocala, my hometown of 
Florida, said,

       I understand there is an FDA proposal to withdraw certain 
     inhaler medications. As an asthmatic patient with a daughter 
     and 3 grandchildren who are also asthmatic, I protest your 
     proposal vehemently. The CFC and the metered dose inhalers 
     have minimal impact on the environment, and any one of my 
     family could suffer or die because of your phasing out the 
     proposal. You will be responsible.

  Another man from Ocala, FL, writes,

       In September 1993, I was discharged from the hospital under 
     the care of a hospice. I had been confined for almost a month 
     with viral pneumonia and was being treated with a wide range 
     of medications, including 16 liters a minute of oxygen. The 
     pulmonary specialist who had attended me had given up hope 
     and estimated that I could live for perhaps 2 weeks. Needless 
     to say, they were wrong and I survived but my lungs are 
     severely damaged. I have been using three different MDI 
     medications ever since my `recovery' and would not survive 
     without them. Great strides have been made in elimination of 
     these products in refrigeration systems and in various 
     aerosol sprays but MDI products must be viewed in a totally 
     different way. They are essential to the health of many 
     persons as opposed to the other products which were used for 
     comfort or convenience. Moreover, reasonable substitutes have 
     been found for nonmedical products. This is not the case for 
     MDI's. Potential substitutes must be subjected to the usual 
     comprehensive scrutiny that the FDA applies to all 
     medications. I cannot believe that the tiny amount of CFC's 
     released by MDI's would produce a detectable level of CFC in 
     the atmosphere between now and the time a medically safe 
     substitute can be developed. I urge the FDA and the EPA to 
     postpone action on elimination of CFC's from metered dose 
     inhalers until such a medically safe substitute is found.
  In conclusion, another woman from Ocala states,

       My life depends on MDI's and I am never without three of 
     them, and they all contain different medicines. I'm 69 years 
     of age and I've used them most of my adult life and I cannot 
     understand the big rush suddenly to ban the MDI's. It is 
     frightening to think of the ban since my very life depends 
     upon it.

  Mr. Speaker, these are just a few of the 10,000 letters that the FDA 
has received. I hope my colleagues will sponsor my bill. We must halt 
the FDA's action, which is harmful to patients.

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