[Congressional Record Volume 143, Number 142 (Tuesday, October 21, 1997)]
[Senate]
[Pages S10882-S10884]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. HUTCHINSON (for himself and Mr. Inhofe):
  S. 1299. A bill to limit the authority of the Administrator of the 
Environmental Protection Agency and the Food and Drug Administration to 
ban metered-dose inhalers; to the Committee on Labor and Human 
Resources.


                THE ASTHMA INHALER REGULATORY RELIEF ACT

  Mr. HUTCHINSON. Mr. President, I come to the Senate floor to talk 
about an issue which literally means life and breath to 30 million 
Americans. It appears that in an effort to clean up the environment, 
some heavy-handed bureaucrats are willing to reduce the quality of life 
for those Americans--children, adults, and senior citizens--who are 
dependent upon inhalers like this inhaler that I have with me today. As 
I rode the elevator up to the Chamber, I mentioned to the elevator 
operator what I was going to be doing. She said, ``Well, please do it 
because it means life to me. I have to have this to breathe.''
  I have a nephew, John Paul, who is an asthmatic, who has been 
dependent upon these inhalers that would be outlawed unless we act as 
the Senate.
  Because of this, I am offering the Asthma Inhaler Regulatory Relief 
Act, AIRR, which would block the Food and Drug Administration from 
banning certain metered dose inhalers, MDI's. I am glad today that 
Senator Shelby, Senator Bond, and Senator DeWine have all joined as 
original cosponsors on this legislation. Senator DeWine has a special 
interest in this, with four of his children, it is my understanding, 
being asthmatics and being dependent upon these inhalers. These 
inhalers are used by nearly 30 million Americans who suffer from 
respiratory diseases such as asthma, chronic obstructive pulmonary 
disease, and cystic fibrosis. These people have come to rely on their 
inhalers as a lifeline for daily living. Yet, the FDA at this time, in 
its very questionable wisdom, has decided that inhalers severely damage 
the environment and must be banned. One of only a few avenues to the 
outside world, the FDA would seal this avenue and ban these inhalers.
  The FDA initially published an advanced notice of a proposed 
rulemaking to eliminate the use of MDI's that use chlorofluorocarbons 
on March 6, 1997. About this time, I received several letters which 
initially sparked my interest in the issue. I have come to

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find out that the FDA, in collaboration with the Environmental 
Protection Agency, proposed this rule as part of the EPA's desire to 
eliminate all uses of chlorofluorocarbons as soon as possible. Most 
metered dose inhalers use CFC's as the propellant to deliver the 
medicine from the inhaler to the lungs of the patient. Under the 1987 
Montreal protocol CFC's are to be phased out globally by the year 2005. 
However, certain uses of CFC's, including this inhaler, were explicitly 
recognized by signatories of the protocol as vital to human health 
while posing relatively little harm to the environment. This exception 
has allowed the continued manufacture and use of inhalers which use 
CFC's as their propellants.
  This exception, however, is being threatened by the Food and Drug 
Administration despite the objections of many, including the American 
Academy of Family Physicians. In their May 5, 1997 letter to Michael 
Friedman, Deputy Commissioner of the FDA, the physicians wrote:

       The Academy believes that the proposed rule might 
     negatively affect our patients' health care and urges the FDA 
     to continue to deem MDI's as ``essential'' under the Montreal 
     Protocol.

  These are the doctors who deal with our children day in and day out. 
They reiterated twice in their letter that they support eliminating 
CFC's from the environment but feel that this shortened timetable is 
not necessary and may be detrimental, very detrimental to their 
patients' health.
  Carol Browner, the Administrator of the Environmental Protection 
Agency, has come to the Congress on numerous occasions to lobby on 
behalf of EPA's proposed clean air standards. I serve on the clean air 
subcommittee. We have had Administrator Browner before us numerous 
times as an advocate for children. One of the most compelling arguments 
she has made on behalf of these new air standards is that she is saving 
the children and the elderly from unnecessary respiratory illness. I 
respect Ms. Browner for her zeal to protect children and the elderly, 
but I find it ironic and amazing and I have to wonder how she can 
support taking the medication away from those whom she claims to be 
trying to protect.
  I wonder how she can look these children in the eye and tell them she 
is taking away the one thing that allows them to play outside and enjoy 
the high-energy activities of running, climbing and participating in 
sports. Ms. Browner's actions will literally rob them of their 
childhood and force them to sit on the sidelines. Of course, the EPA 
has an answer. First, the EPA and the FDA will tell us there are other 
MDI's available that will provide the necessary protection for these 
children. The truth is there is only one that is currently available. 
Many are in the research and development stages, but that pales in 
comparison to the hundreds of these inhalers that are available 
currently.
  Doctors will tell you that different patients react differently to 
different medications. There are many inhalers that are virtually 
identical in composition yet have dramatically different effects on 
various patients. Again, quoting the American Academy of Family 
Physicians:

       We are concerned that the proposed rule will severely limit 
     the number of therapies available to our patients. We know 
     that a drug that works for one patient may not work for 
     another. We would like our members to have the flexibility to 
     try different therapies to find the one that is most 
     effective for their patients.

  Simply put, 1 inhaler is not enough and 10 is not enough. Doctors 
must have the ability to choose the medication that best suits their 
patients. In the case of respiratory treatment, one size definitely 
does not fit all.
  Another concern I have with allowing one inhaler to dominate the 
market is the cost to the consumer. Obviously, where there are hundreds 
as currently exist, including many generic brands, there will be lower 
prices for the consumer. If we allow the FDA and the EPA to ban CFC 
inhalers, many may not be able to afford the treatment. The majority of 
patients who suffer from these symptoms live in the inner-city where 
the cost of living is very high and their income very low. These 
families rely on inhalers which can cost eight times less than newer 
name brand products without CFC's. If these children from low-income 
inner-city families lose the most accessible inhaler, they are less 
likely to continue adequate treatment which is so important to a normal 
life.
  According to a recent Wall Street Journal article, the Joint Council 
of Allergy, Asthma and Immunology has told both the FDA and the EPA 
that because of these increased costs, their proposal will unfairly 
punish poor children and the elderly who have the highest risks of 
asthma-related sickness and death.
  A certain consequence of a decrease in the use of inhalers as part of 
a schedule to keep asthma in control is an increase in hospital 
admissions and an increase in deaths. According to a panel of the 
National Institute for Allergies and Infectious Diseases, between 1980 
and 1993 failure to comply with treatment explains a 300 percent 
increase in asthma-related deaths among children. This proposal put 
forth by the EPA and the FDA will increase costs and can only worsen 
this statistic.
  Another common argument the EPA will use is that by banning CFC's, we 
are making the air more safe for children and the elderly. While 
certainly there are studies that show these gases are harmful and 
increase the probability that an asthmatic will have an attack, if you 
look at the statistics, you will find that inhalers, such as this one, 
account for at most 1.5 percent of all CFC's produced in the world. The 
EPA supports taking away nearly 30 million people's inhalers to 
eliminate approximately 1.5 percent of the CFC's produced. That hardly 
seems like a logical target for reducing CFC's and preserving and 
maintaining the health of the American people.
  In the October edition of Insight Magazine, Robert Goldbert, senior 
research fellow at George Washington Center For Neuroscience, 
determines that banning MDI's that only account for 1.5 percent of CFC 
emissions is another cynical exploitation of kids for the sake of 
environmental correctness.
  I do not believe that this proposal is part of a strategy to save the 
ozone layer. I believe it is a strategy to use children as a political 
tool for an end that I frankly do not understand. We cannot allow the 
FDA and the EPA to require children and senior citizens to foot the 
bill for reductions in CFC's that will do no good, while hurting the 
most vulnerable.
  These actions, if allowed to proceed, will literally rob these 
children of their childhood and significantly reduce the quality of 
life of all those dependent on inhalers.
  I urge the Presiding Officer and all of my colleagues who may be 
listening today to join in cosponsorship of what I think is commonsense 
legislation and that is going to be to the benefit of 30 million 
Americans including children and the elderly and those who are most 
vulnerable in our society.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 1299

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Asthma Inhaler Regulatory 
     Relief Act''.

     SEC. 2. LIMITATION ON AUTHORITY TO BAN METERED-DOSE INHALERS.

       Neither the Administrator of the Environmental Protection 
     Agency nor the Commissioner of Food and Drug Administration 
     may prohibit the manufacture, distribution, or sale of 
     metered-dose inhalers that use chlorofluorocarbons unless the 
     Administrator of the Environmental Protection Agency and the 
     Commissioner of the Food and Drug Administration jointly 
     certify to the Congress that alternatives to such inhalers 
     are available that, for all populations of users of such 
     inhalers, are comparable in terms of safety and 
     effectiveness, therapeutic indications, dosage strength, 
     costs, and retail availability.

     SEC. 3. MORATORIUM ON FURTHER RULEMAKING.

       The Commissioner of the Food and Drug Administration shall 
     withdraw the March 6, 1997, advance notice of proposed 
     rulemaking concerning chlorofluorocarbons in metered-dose 
     inhalers and shall not issue any other proposal until after 
     the 10th Meeting of the Parties to the Montreal Protocol on 
     Substances That Deplete the Ozone Layer. Any subsequent 
     proposal shall be in the form of an advance notice of 
     proposed rulemaking and shall be initiated only after 
     extensive consultations with patients, physicians,

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     other health care providers, manufacturers of metered-dose 
     inhalers, and other stakeholders.

     SEC. 4. DEVELOPMENT OF STRATEGY.

       (a) In General.--Following the 10th meeting of Parties to 
     the Montreal Protocol on Substances That Deplete the Ozone 
     Layer, but not later than January 30, 1999, the Commissioner 
     of the Food and Drug Administration shall publish a new 
     advance notice of proposed rulemaking, setting forth the 
     initial strategy for facilitating the transition in the 
     United States to metered-dose inhalers that do not use 
     chlorofluorocarbons.
       (b) Obligations Under Montreal Protocol.--The initial 
     strategy developed under subsection (a) shall be submitted by 
     the Secretary of State to the Montreal Protocol Secretariat 
     by January 31, 1999, to fulfill United States obligations 
     under the Montreal Protocol decision IX/14.
                                 ______