[Congressional Record Volume 143, Number 111 (Thursday, July 31, 1997)]
[Extensions of Remarks]
[Page E1574]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


       PATIENT ACCESS TO METERED DOSE INHALERS MUST BE PRESERVED

                                 ______
                                 

                       HON. CHRISTOPHER H. SMITH

                             of new jersey

                    in the house of representatives

                        Wednesday, July 30, 1997

  Mr. SMITH of New Jersey. Mr. Speaker, today the House Subcommittee on 
Health and Environment conducted an important hearing on the issues 
surrounding the Montreal Protocol of 1987, which bans the use of ozone 
depleting substances.
  As many of my colleagues know, the Food and Drug Administration [FDA] 
recently unveiled a proposal to eliminate essential-use exemptions for 
metered dose inhalers [MDI's]. Mr. Cliff Stearns, my good friend from 
Florida, and I have introduced legislation [H.R. 2221] aimed at helping 
those suffering from respiratory conditions, particularly children with 
asthma and cystic fibrosis [CF], preserve their access to medicines 
they rely upon to breathe--metered dose inhalers.
  H.R. 2221 requires the FDA and the Environmental Protection Agency 
[EPA] to delay their plans to remove chlorofluorocarbon-based MDI's 
from the marketplace before 2005. If Congress allows the FDA's ill-
advised plan banning CFC MDI's to take effect, the 30 million Americans 
suffering from respiratory diseases could be placed at risk.
  When the symptoms of these diseases strike, patients reach for the 
safe, effective, and proven medication delivery systems that have kept 
them alive for years--metered dose inhalers. Quite literally, metered 
dose inhalers are a matter of life and breath.
  Currently, all metered dose inhalers, save one, are powered by 
chlorofluorocarbon [CFC] propellants. Under the 1987 Montreal Protocol, 
as amended, CFC's are to be phased-out globally because of the possible 
negative impact on the ozone layer. It is important to point out, 
however, that the signatories to the Montreal Protocol explicitly 
recognized that certain uses of CFC's generate tremendous health and 
safety benefits. Consequently, MDI's were given a temporary essential-
use exemption from the treaty.
  Despite this global exemption, the U.S. FDA has unilaterally decided 
to accelerate the phase-out of CFC-containing metered dose inhalers. 
Under the FDA's proposed framework, CFC-containing inhalers--used 
safely and regularly by millions of asthmatic children, adults, and 
senior citizens--would be banned and consumers would be forced to 
purchase alternative products, even if there was but a single 
alternative on the market.
  Indeed, as of today, only one company has received FDA approval to 
manufacture non-CFC MDI's. Although pharmaceutical companies are 
currently developing CFC-free MDI's, the FDA proposal will force 
patients to abandon their existing medications and create a de facto 
monopoly in the substantial MDI market. Respiratory patients will lose 
the benefits of free-market competition, and the less well-off will be 
unfairly burdened with higher prices.
  While adults may not notice the different taste, smell, or sensation 
of a CFC-free inhaler, an 8 year-old child might be reluctant to use 
his or her new MDI because it tastes funny. I have four children, and 
both of my daughters, Melissa and Elyse, have asthma. Like everybody 
else, people have different tastes and preferences. Any parent with 
children knows that it can be difficult to get them to take a 
medication perceived to be unpleasant. That is why there are dozens of 
flavors of cough syrups and cold medicines in the pharmacy.
  But there is a big difference between cough syrup and MDI's--the 
failure to properly use an MDI can kill you. Mr. Speaker, it is a well 
known fact that asthma is currently the number one reason for 
children's school absences, and that roughly 5,000 Americans die each 
year from asthma-related complications. Furthermore, for millions of 
asthma sufferers, the single most important part of successful 
treatment is maintaining a steady medication routine. Disrupting this 
routine, which is a certain byproduct of FDA's proposal, will 
needlessly put the lives and health of our children and senior citizens 
at risk. That is why the one-size-fits-all policy FDA is pursuing is 
counterproductive.
  In addition, the amount of CFC's used in metered dose inhalers is so 
small--less than 0.025 kg per inhaler--that the marginal environmental 
improvement in the ozone layer that would result from the FDA plan 
would be virtually undetectable. Indeed, MDI's are responsible for less 
than 1 percent of the risk to the ozone layer as measured by 
atmospheric chlorine levels.
  Equally perplexing about FDA's proposal is that asthma patients in 
the United States will have their dependable and effective medications 
taken away from them while consumers in China and Indonesia continue to 
use CFC's in hair spray and cosmetics until 2010.
  There is no doubt that pharmaceutical companies should be encouraged 
to develop, test, and bring alternative products to market before 2005. 
However, it is terribly shortsighted to pull the plug on CFC-containing 
MDI's before there is a free market in tested, proven, and accepted 
alternative products.
  Mr. Speaker, I believe there is an alternative approach for the FDA 
to follow: allow the existing products to be used until 2005, and 
encourage the development and use of alternative [CFC-free] metered 
dose inhalers so that asthma patients can gradually become accustomed 
to the different medications without undue disruptions and risks. 
Rather than forcing patients to suddenly switch medications and 
involuntarily, a more sensible approach would allow environmentally 
safe products to flourish and attain widespread acceptance.
  I call upon my colleagues on both sides of the aisle to reject the 
FDA's cold-turkey policy--Australia has already rejected that strategy, 
and they have the highest rate of skin cancer anywhere in the world. If 
the Australians--who have the most to lose from the destruction of the 
ozone layer--find the FDA's model objectionable, surely the United 
States can achieve its goal of zeroing out CFC production in 2005 
without the heavy-handed, one-size-fits-all approach that the FDA has 
proposed. The children and senior citizens who depend on metered dose 
inhalers to breathe and live normal lives deserve better.

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