[Congressional Record Volume 144, Number 52 (Friday, May 1, 1998)]
[Senate]
[Pages S4036-S4037]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DeWINE (for himself and Mr. Hutchinson):
  S. 2026. A bill to require the Commissioner of Food and Drugs to 
conduct assessments and take other actions relating to the transition 
from use of chloroflurocarbons in metered-dose inhalers, and for other 
purposes; to the Committee on Labor and Human Resources.


                   the asthma inhaler protection act

  Mr. DeWINE. Mr. President, I come to the floor this afternoon to 
introduce, along with my good friend Senator Tim Hutchinson of 
Arkansas, the Asthma Inhaler Protection Act.
  This bill is designed to protect the millions of Americans who use 
medical inhalers for diseases such as asthma and cystic fibrosis. This 
Asthma Inhaler Protection Act is needed to make sure that the Food and 
Drug Administration is extremely--extremely--careful in how it phases 
out the use of asthma inhalers that contain chlorofluorocarbons, or 
CFCs.
  This bill that Senator Hutchinson and I are introducing today makes 
sure that as FDA phases out the use of inhalers with CFCs, adequate 
replacements are available that meet all patients' needs. That is the 
key.
  Mr. President, there are 15 million Americans who have asthma, almost 
all of whom regularly use asthma inhalers such as this one, 15 million 
Americans who have asthma, many of whom use inhalers just like the one 
I took out of my pocket. They use these inhalers to help them control 
their disease. Without having access to a drug that meets his or her 
specific needs, each of these Americans would be adding much greater 
risk of having an asthma attack or, if they have an asthma attack, not 
being able to control it short of going to the emergency room in a 
hospital, which is where many people had to go before they had access 
to these inhalers.

  I had the personal experience with our daughter Becky a number of 
years ago when she was small and she had asthma. The doctor finally, 
after we had been to the emergency room time after time, said I think 
she needs to use these new inhalers that are on the market, even though 
they had not been prescribed for children at that time. He said go 
ahead and use it. So Becky started using these and it made her life a 
lot easier, certainly the life of her parents, as well.
  Without access to a drug that meets these specific needs, each of 
these asthma sufferers would be in greater danger. Without an 
appropriate medication, they also would have a much worse chance of 
stopping an asthma attack once it has begun.
  What is the problem? The problem is almost all asthma inhalers 
currently on the market contain CFCs. Almost every single one of them 
changes this.

[[Page S4037]]

 Under international agreement, this country has agreed to the goal of 
eventually eliminating all uses--all uses--of CFCs.
  What this means for asthma patients is that over a period of many 
years new inhalers that don't use CFCs will be brought to the market, 
and use of the old inhalers that contain CFCs will be phased out. But 
as we do this, as we comply with this international agreement--and 
this, of course, is something that was agreed to because of the concern 
for the environment, and I understand that--I think as we do this we 
must make sure this transition process is done very, very carefully and 
that we do it with the utmost attention to those individuals whose 
quality of life may depend on the use of these inhalers.
  We must be absolutely sure that if and when we take an inhaler that 
contains CFCs off the market there are adequate replacements that meet 
the needs of each and every person that currently uses the old-time 
inhaler. My one and only goal when it comes to this transition is to 
make sure that all people, all people who rely on these drugs, continue 
to have access to inhalers that have been proven, already proven to 
meet their needs. All other issues are secondary to making sure that 
these patients are, in fact, protected.
  In March of 1997 the FDA released its first proposal on how to go 
about this transition. Now, simply put, the FDA's initial response does 
not meet the goal of fully protecting asthma patients. The medical and 
patient communities have been unanimous in expressing concern that the 
FDA's proposal, when it goes into effect, could take existing 
medications away from patients without adequate replacements being at 
that time available. The bottom line is that the FDA's proposal could 
and will put patients at risk.
  What do we do about it? Where do we go from here? I understand that 
many people believe the FDA has seen the light. Some people tell me 
they plan to correct the problems in their initial proposal during the 
next step of the process, the next step of the process being the 
proposed rule. Now, I would like to believe that this will happen, but 
I am not sure it will.
  It is now over a year since the FDA released its earlier proposal, 
but despite all the public criticism which has ensued there has never 
been a single public statement by that agency that it intends to change 
the policy to address these very legitimate medical concerns. That is 
why I feel congressional action is necessary.
  That is why Senator Hutchinson and I are introducing this bill today. 
We need to be sure that the FDA, as it pursues this transition, writes 
its policy so that all patients are protected. Because of this, I am 
pleased to cosponsor this legislation, S. 1299, a bill that Senator 
Hutchinson introduced last year. Let me say that Senator Hutchinson has 
been someone who has taken the lead in this crusade.

  That bill lets the FDA know in the clearest of terms that its initial 
proposal was unacceptable and that bill further gives the FDA guidance 
on how it should proceed with the rules for this transition.
  Let me again congratulate my colleague from Arkansas for his 
leadership on this issue and for the introduction of his work on that 
bill. Since last year, Mr. President, I have continued to work on this 
issue. I have had my staff explore various options and various 
proposals. We have identified several additional ideas I believe are 
important to make sure that patients are protected and that should be 
included in any legislation on the phaseout of CFC inhalers.
  Recently, I have worked with Senator Hutchinson to develop these 
thoughts into this piece of legislation that we are introducing today, 
the Asthma Inhaler Protection Act. Our bill does these things: First, 
it makes sure that the FDA, before it takes the next step of publishing 
a proposed rule, has looked at several issues that are necessary for 
the agency to make informed choices in this area. Second, our bill 
gives the FDA the broad outline of what the transition policy should 
look like so that all patients' needs are protected. Finally, our bill 
will help save FDA resources by telling the agency to not review any 
new drug applications for products that contain CFCs unless the new 
product represents a significant new medical advance.
  I want to make clear that this bill is not necessarily a finished 
product. We are open to additional ideas and suggestions. We will 
consider any additional thoughts and ideas on how to improve the bill 
to make sure that people who use asthma inhalers are truly protected.
  I hope my colleagues and anyone interested in the safety of Americans 
with asthma could look at this bill and consider supporting it. I 
believe this bill is crucial to get FDA back on the right course. It is 
absolutely necessary so that no asthma patients are ever put in a 
situation where they can't get the best inhalers that fit their very 
specific medical needs.
  Again, I urge my colleagues to cosponsor this bill, which I believe 
is a matter of good common sense, and a bill that will help protect the 
asthma sufferers of this country.
                                 ______