[Congressional Record Volume 144, Number 55 (Wednesday, May 6, 1998)]
[Senate]
[Pages S4412-S4413]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                            ASTHMA INHALERS

  Mr. HUTCHINSON. Madam President, today, as you may be aware, is 
Asthma Awareness Day. I rise to discuss the issue of CFC-propelled 
asthma inhalers.
  CFC-propelled inhalers are a necessary tool for proper management of 
asthma and other respiratory illnesses. Over 30 million Americans 
depend on these inhalers in order to function normally in their daily 
lives. In many cases, they are literally the difference between life 
and death.
  I recently joined my colleague, Senator DeWine, in introducing S. 
2026, the Asthma Inhaler Protection Act. This bill is a revised version 
of legislation that I introduced last year in response to the Food and 
Drug Administration's announcement of its plans to issue a rule that 
will phase out the production of CFC-propelled inhalers.
  The FDA's announcement to phase-out metered-dose inhalers was 
prompted by the Montreal Protocol agreement to eliminate ozone 
depleting chemicals, including CFCs. In the U.S., the manufacture of 
CFCs was discontinued in January of 1996. CFCs may still be used, 
however, as long as their use qualifies as an ``essential use.'' 
Currently, inhalers are considered as ``essential use'' and are exempt 
from the CFC ban.
  As the United States contemplates total elimination of CFCs and 
removal of the essential use designation for inhalers, we face several 
issues.
  First of all, how fast should we phase out CFC inhalers and will 
patients' health be jeopardized? It is my understanding that the amount 
of CFCs released by metered-dose inhalers accounts for less than 1.5 
percent of the total amount emitted into the atmosphere. Is the 
environmental benefit of phasing out inhalers without taking into 
account the full needs of patients worth placing lives in danger?
  As a member of the Senate Environment and Public Works Committee and 
the Senate Labor and Human Resources Committee, I support the goal of 
ridding our environment of ozone depleting chemicals.
  However, from a patient perspective, any transition to CFC-free 
alternatives that does not take into account the needs of all patients 
will do more harm than good.
  Under the FDA's initial proposal, a whole class of inhalers could be 
removed from the market if only three alternatives exist. The method by 
which the FDA has grouped inhaler medications into classes assumes that 
they are medically and therapeutically equivalent. I suggest to my 
colleagues this is FALSE.
  Inhalers vary in terms of formulation, dosage strength, delivery of 
medication, and their effectiveness for patients. Patients frequently 
test several inhalers under physician supervision before they find the 
inhaler that works best for them. To deny patients their inhaler 
without a suitable range of alternatives could potentially put their 
lives at risk.
  Another concern that cannot be overlooked is how the removal of 
existing products and their generic counterparts will influence the 
marketplace. A decrease in competition has obvious consequences in 
terms of cost and the availability of drugs on the shelf.
  Finally, the FDA should take into account other countries' strategies 
for phasing out CFCs in inhalers in order to ensure that the U.S. takes 
the best and most responsible approach. I know that Canada, for 
example, has rejected the class approach taken by the FDA and proposed 
a policy that will require a proper range of alternatives to exist for 
each medication type. It also provides for a transition period so 
patients can ease off of their current medication and make sure that 
there is a new product that accommodates their needs.
  The Asthma Inhaler Protection Act addresses all of these issues by 
including three requirements. First, before any further rulemaking, the 
FDA must conduct assessments and report to Congress on the health and 
environmental risks associated with its initial proposal. It must also 
consider whether any measures adopted by the meeting of the Montreal 
Protocol this November will facilitate the United States' transition 
away from CFC inhalers.
  Second, the FDA is required to develop criteria by which ``essential 
use'' allowances for CFC-propelled inhalers will be removed. These 
criteria shall require that a range of alternatives are available for 
each medication type, and that they are comparable in terms of dosage 
strength, delivery systems and safety and efficacy. Furthermore, the 
alternatives must be available in sufficient numbers to meet consumer 
demand.
  Finally, the Asthma Inhaler Protection Act includes steps to ensure 
that manufacturers will begin to transition away from inhalers that 
employ CFCs. Under the bill, no new applications for products 
containing CFCs will be considered by the FDA after 1998 unless they 
represent a significant advance in technology. Any new approvals, 
however, will be subject to the same criteria as I described earlier.
  Madam President, the transition to non-CFC propelled inhalers in the 
United States must be well-planned and take into account both patient 
and environmental concerns. It is clear that the FDA needs to rethink 
its approach. We knew this last year after the FDA published its 
proposal and was flooded by more than 10,000 comments from concerned 
patients, providers, state medical boards, and advocacy groups. These 
concerns were again raised last month during a Senate Labor and Human 
Resources Committee hearing which Chairman Jeffords held at my request.
  The Asthma Inhaler Protection Act will ensure that the FDA balances 
patients needs with environmental concerns, and above all, does not 
jeopardize the lives of millions of Americans who depend on CFC 
metered-dose inhalers.
  It is simply a matter of ensuring that the 30 million Americans 
currently dependent upon these inhalers--and all of us have seen them; 
these little canisters that asthmatics carry with them every day 
everywhere they go--we simply must ensure that as the FDA moves forward 
that they will do so in a way that ensures that patients all across 
this country are not allowed to go without medical care that they so 
desperately need; and that the policy of the FDA will be such that 
these patients will know that they are not going to have less choice 
than they have now; that the particular peculiar medical needs that 
asthmatics and others of respiratory diseases have will be met; that 
they will be assured that the needs that they have can be addressed; 
and, that the FDA will take those concerns into account as they move 
forward.
  I believe the FDA will be responsive. This legislation, though, is 
there, and I am looking forward to working with Senator DeWine, 
Congressman Patrick Kennedy and Congressman Mark Foley on the House 
side to ensure that as the FDA moves forward with its rulemaking that 
it will do so in a way that is going to ensure that 30 million

[[Page S4413]]

Americans are cared for and are not left in the lurch worried that 
their very lives might be in danger.
  I hope all of us on this day, the first Asthma Awareness Day, will do 
our part to educate the American people about the serious health 
impact, particularly upon our children, that asthma is having, and the 
dramatic increase that we have seen in asthma in this country, and that 
the FDA in their, I think, well-motivated goal of removing these 
chemicals from our environment will do so in a way that the health and 
safety of the American people is protected.
  I yield the floor.
  Mr. WELLSTONE addressed the Chair.
  The PRESIDING OFFICER. The Senator from Minnesota is recognized.
  Mr. WELLSTONE. Madam President, I ask unanimous consent for 5 minutes 
to speak as if in morning business.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. WELLSTONE. Madam President, I thank my colleagues for their 
graciousness, and I especially thank Senator Gramm of Texas. I 
appreciate it.

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