[Congressional Record Volume 143, Number 123 (Tuesday, September 16, 1997)]
[Extensions of Remarks]
[Pages E1766-E1767]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                   PHASING OUT METERED DOSE INHALERS

                                 ______
                                 

                        HON. PATRICK J. KENNEDY

                            of rhode island

                    in the house of representatives

                      Tuesday, September 16, 1997

  Mr. KENNEDY of Rhode Island. Mr. Speaker, I would like to take this 
opportunity to offer my position on an issue that I know is of great 
concern to my constituents in Rhode Island and the Nation at large.
  The U.S. Food and Drug Administration has recently proposed 
regulations which would impact the lives of thousands of Rhode 
Islanders

[[Page E1767]]

suffering from respiratory problems such as asthma and cystic fibrosis.
  These new regulations would begin to phase out metered dose inhalers, 
which are used as the primary delivery apparatus of medication to over 
14 million citizens with respiratory ailments. This action is being 
taken to help the United States implement the Montreal Protocol Treaty 
in which 49 countries have agreed to work toward eliminating substances 
that deplete the ozone layer and contribute to the effect known as 
global warming.
  As an environmentalist, I strongly support the work of the Montreal 
Protocol and its goal to improve the quality of our lives by protecting 
our environment. Over the last 10 years, this international initiative 
has greatly contributed to reducing dangerous diseases like cataracts 
and skin cancer which are directly associated with ozone layer 
depletion.
  Scientists have identified that chloroflurocarbons are one of the 
elements which cause global warming and ozone layer depletion. In 
accordance with the Montreal Protocol, the United States has worked to 
greatly reduce the presence of chloroflurocarbons in many of our daily 
life products such as aerosol containers and air conditioners.
  Unfortunately, the FDA's proposal concerning metered dose inhalers 
creates a Catch-22. Some 30 million Americans, particularly children 
and elderly, are faced with respiratory disease which requires the use 
of inhalers. These medications are proven to be safe and effective by 
the FDA. Moreover, they are cost effective, providing many citizens, 
especially those in low-income situations, access to prescription 
medication.
  Asthma, in particular, is getting the best of many of our citizens. 
More than 20,000 children in Rhode Island live with asthma and it is 
the No. 1 reason for school absences. Over 5,000 people die each year 
from asthma complications. As an asthmatic, I can definitively say that 
this is a serious public health threat.
  The FDA's preliminary proposal may have a dramatic effect on the 
availability of affordable asthma medication. Restricting metered dose 
inhalers may create a situation which will decrease the ability of 
those with asthma and cystic fibrosis to obtain the medication that 
they need so desperately. As a result, the new method of medication for 
asthma has the potential, because of existing market forces, to be far 
more expensive in the next few years.
  My asthma medication costs exceed $100 per month, which I am 
fortunate to have the ability to pay. But the families of thousands of 
children, as well as the elderly, are struggling to meet their 
prescription needs. Ironically, the FDA may be inadvertently driving up 
the cost of asthma medication in its attempt to implement what is 
essentially an excellent international treaty with noble purposes.
  While I applaud the efforts and innovations of certain companies to 
create new forms of respiratory medication, there is a potential cost 
factor associated with these innovations when they first reach the 
market. This immediate change in potential cost, which impacts millions 
of working-class families, is of great concern to me.
  I want to strongly encourage the private sector and the FDA to keep 
pushing the envelope to bring our Nation in alignment with the Montreal 
Protocol. But to potentially limit an approved medical product before 
the new ones are universally accessible and affordable is simply 
premature.
  If the price for asthma medication rises and more children and 
elderly are unable to get their medication, we will have a public 
health crisis on our hands.
  The bottom line must be the protection of public health. I would hope 
we can reduce chlorofluorocarbons without restricting metered dose 
inhaler use, which are responsible for less than 1 percent of all 
atmospheric chlorine in the Earth's ozone layer. Clearly, there must be 
another alternative to reduce global warming and chlorofluorocarbon 
production without harming the people we are ironically trying to 
protect through improved environmental quality.
  The Montreal Protocol has specifically authorized essential use 
allowances until the year 2005 for certain products like metered dose 
inhalers because they are so important.
  In my view, metered dose inhalers are categorically essential because 
so many people depend on them. That is the bottom line that we must 
commit to, and that is a line we should not cross until we are sure 
that everyone who suffers from asthma and other respiratory ailments 
have full access to any new products that come to the marketplace.
  The Montreal Protocol is a step in the right direction. The United 
States should make every effort to comply with this beneficial treaty. 
We should also, if proven necessary, move toward a new form of 
respiratory medication that does not contain a chlorofluorocarbon-
producing element.
  Yet in our zeal, we must not throw out the baby with the bathwater. 
Until the new methods are proven in the marketplace, our first national 
responsibility must be to the millions of Americans whose lives depend 
on the metered dose inhalers that are available and accessible today.

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