[Congressional Record Volume 143, Number 97 (Thursday, July 10, 1997)]
[Extensions of Remarks]
[Page E1387]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

[[Page E1387]]



           PRESERVING PATIENT ACCESS TO METERED DOSE INHALERS

                                 ______
                                 

                       HON. CHRISTOPHER H. SMITH

                             of new jersey

                    in the house of representatives

                        Wednesday, July 9, 1997

  Mr. SMITH of New Jersey. Mr. Speaker, today Mr. Cliff Stearns, my 
good friend from Florida, and I are introducing legislation aimed at 
helping those who suffer from respiratory conditions, particularly 
children with asthma, and preserve their access to medicines they rely 
upon to breath--metered dose inhalers (MDI's).
  Our legislation calls upon the Food and Drug Administration [FDA] and 
the Environmental Protection Agency [EPA] to delay their plans to 
remove chlorofluorocarbon-based MDIs from the marketplace before 2005. 
The resolution implores the EDA to continue to allow these critically 
important medicines to remain on the market while environmentally safe 
alternatives are developed and manufactured.
  As many of you know, nearly 30 million Americans suffer from 
respiratory diseases of one kind or another, including asthma, chronic 
obstructive pulmonary disease [COPD], and cystic fibrosis. 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 enable patients to breathe freely and often mean the 
difference between life and death.
  These inhalers are generally powered by chlorofluorocarbon [CFC] 
propellants. Under the 1987 Montreal Protocol, CFC's are to be phased 
out globally because of the damage they are believed to cause to the 
ozone layer. I believe it is important to point out, however, that the 
signatories to this Protocol explicitly recognized that certain uses of 
CFC's--such as MDI's--pose relatively small environmental risk yet 
generate tremendous health and safety benefits, and consequently, MDIs 
were given a temporary Essential-Use exemption from the treaty.
  Despite this global exemption and the internationally recognized 
health benefits of MDI's, the U.S. FDA has unilaterally decided to 
accelerate the phase-out of CFC containing metered dose inhalers. Under 
the 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. I believe that this proposal is outrageous and totally 
unwarranted at this time.
  Although pharmaceutical companies are working diligently to develop 
CFC-free MDI's, the FDA proposal will force patients to abandon their 
existing medications and could place them at the mercy of a single 
supplier in certain cases. This is fatally flawed in two important 
respects: first, each patient is unique and responds differently to 
asthma medication--even to the same medication--so the one-size-fits-
all approach that FDA is pursuing will harm many of these patients; and 
second, consumers will be charged higher prices due to the lack of 
competition in alternative MDI products.

  Mr. Speaker, it is a well known fact that asthma is currently the No. 
1 reason for 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 the FDA's proposal, will 
needlessly put the lives and health of our children and senior citizens 
at risk.
  I am also dismayed that the FDA, by seeking to ban CFC MDI's even 
when only a single alternative MDI is on the market, is making the 
erroneous assumption that all significant patient subpopulations--such 
as children and the elderly--will be equally served by the alternative 
product. This assumption is not only incorrect, but it violates the 
FDA's very own procedures and rules. All products that wish to obtain a 
pediatric indication must be reviewed separately by the FDA to 
determine whether the effect of a drug on children is the same as an 
adult. Yet, in its zeal to phase out CFC products before the United 
States is even required to do so, the FDA is trampling on this 
principle.
  An additionally egregious aspect of the FDA's proposed rule is that 
it is an answer in search of a problem. The United States is in 
absolutely no danger of missing the Montreal Protocol's compliance 
deadline (2005) for completely eliminating CFC's, and there is no need 
to abruptly ban MDI's that have been widely and safely used for years.
  Furthermore, 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.
  To put these amounts into perspective, consider that in 1996, 
transitional stockpiles of CFC's for use in air conditioners and 
refrigeration equipment totaled between 36,000 and 72,000 tons. The 
total production of CFC's used for MDI's that year was only 2,600 tons, 
and MDI's are responsible for less than 1 percent of the risk to the 
ozone layer, as measured by atmospheric chlorine levels.
  In addition, while the United States and developing countries must 
eliminate all CFC's by 2005, developing nations can continue to produce 
CFC's until 2010. Unless the FDA drastically modifies or delays its 
plan, asthma patients in the United States will have their dependable 
and effective medications taken away from them while consumers in China 
and Inodonesia continue to use CFC's in hair spray and cosmetics.
  It seems incomprehensible that anybody could support a proposal that 
secures negligible environmental benefits at a very steep cost to human 
lives and health. Notwithstanding, the FDA continues to move forward 
with its plan despite overwhelmingly negative public comments. I 
understand that the magnitude of the public reaction to the FDA's 
advance notice was among the greatest--in terms of the numbers of 
letters received--in recent history. This is even more remarkable 
considering that the ban on metered dose inhalers has received very 
little media coverage.
  In conclusion, Mr. Speaker, let me say there is no doubt that 
pharmaceutical companies should be encouraged by the FDA to develop, 
test, and bring alternative products to market before 2005. However, it 
is absurd and downright dangerous to put asthma patients--including 
children whose very lives depend on adhering to familiar medical 
routines--at risk by pulling effective and safe products from our 
shelves in order to meet a self-imposed standard. There is absolutely 
no reason to disrupt the lives of asthma and cystic fibrosis patients 
in the manner FDA has proposed. That is why I have joined my friend 
Congressman Stearns in introducing this resolution today.
  The alternative approach that we suggest to the FDA is very 
straightforward: allow the existing products--proven safe and effective 
over years of use--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 
switch medications suddenly and involuntarily, our 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. 
The United States can achieve its goal of zeroing out CFR 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 surely deserve better 
than that.

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