[Congressional Record Volume 143, Number 145 (Friday, October 24, 1997)]
[Senate]
[Pages S11176-S11177]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                               FDA REFORM

  Mr. DeWINE. Mr. President, I want to discuss today an important issue 
involving the FDA. First, let me congratulate my colleague from 
Arkansas, Senator Tim Hutchinson, for his fine work on the legislation 
that he has just introduced. This bill that Senator Hutchinson has 
introduced would prevent the FDA from implementing a proposed rule that 
is harmful and unnecessary.
  Mr. President, this is the story. Earlier this year, the Food and 
Drug Administration issued a proposed rule to accelerate the phaseout 
of metered-dose inhalers that are propelled by chlorofluorocarbon 
gases, commonly known as ``CFC's.'' Essentially, Mr. President, the FDA 
has proposed to ban from the market safe and effective medicines that 
millions of Americans use to help them breathe. For many patients, 
these medicines mean, quite literally, the difference between life and 
death.
  This FDA proposed ban is not based on concerns of safety, but rather 
the ban on these inhalers was put forward on the grounds that inhalers 
that use CFCs deplete the Earth's ozone layer. Now, the fact is, Mr. 
President, that these inhalers have only a minimal effect on ozone 
depletion. Asthma inhalers account for only a very small part of this 
problem. It is estimated that asthma inhalers account for less than 1.5 
percent of the total problem.
  Perhaps more important, Mr. President, the companies that make these 
inhalers have already agreed to develop new CFC-free devices by the 
year 2005--the deadline that was previously set forth in the 
international Montreal Protocol. These companies are working hard to 
bring these products to the market quickly and, in fact, they think 
they will beat the 2005 year deadline.
  So I think, Mr. President, it's clear that the FDA's proposed rule to 
accelerate the phaseout of these products yields no significant benefit 
to the global environment. What it will do, however, is take away 
essential medications from Americans who depend on these inhalers to 
manage serious respiratory illnesses.
  Mr. President, over 30 million Americans suffer from some type of 
respiratory disease, including asthma.

[[Page S11177]]

 Many of these patients rely on a combination of inhalers to be able to 
function normally. The FDA's proposed policy would limit their 
treatment options and force them to switch from proven treatment 
regimens that have been carefully adjusted to control their symptoms.
  Mr. President, asthma is a serious national health problem. The 
morbidity and mortality rates from asthma continue to increase in the 
United States, particularly among minority and inner-city children. Mr. 
President, I think we have to question the FDA's judgment in putting 
forth a proposal that puts these patients at further risk. I hope 
others will agree with me as well.
  Mr. President, the FDA has already received over 10,000 letters from 
patients, providers, and health care organizations expressing concern 
about this issue. In a letter to Health and Human Services Secretary 
Donna Shalala, Dr. C. Everett Koop, former Surgeon General of this 
country, wrote the following:

       This proposal will adversely impact patient health, while 
     providing negligible environmental benefit.

  Dr. Koop went on to state:

       Any efforts to limit the medications available to asthma 
     patients and their physicians would be a serious mistake that 
     would lead to severe consequences for American asthmatics.

  Mr. President, there is another aspect to this whole issue. Under the 
proposed guideline, the FDA would remove from the market products that 
have been tested and labeled for use in children and replace them with 
CFC-free versions that while containing the same active ingredients 
have not been tested or approved for use by children. They have not 
been tested or approved for pediatric use. Mr. President, asthma is the 
leading cause of chronic illness among children--5 million children 
suffer from asthma today. How in the world can the FDA remove products 
from the market which are proven to be safe and effective for children 
while at the same time the FDA laments the lack of adequately labeled 
products for children? It just doesn't make sense.
  Mr. President, the Food and Drug Administration is charged with 
protecting the health and well-being of American citizens. It seems 
incomprehensible to me that it could put forth a proposal that secures 
really negligible environmental benefits at a potentially steep cost to 
human lives and health. I urge the FDA to reconsider its proposal. The 
health of millions of Americans who depend on metered-dose inhalers is 
too important.
  Mr. President, I thank the Chair. I yield the floor.
  Mr. BYRD addressed the Chair.
  The PRESIDING OFFICER. The Senator from West Virginia.
  Mr. BYRD. Mr. President, what is the question before the Senate and 
what is the business before the Senate?
  The PRESIDING OFFICER. The Senate is conducting morning business with 
Senators to speak for up to 10 minutes.
  Mr. BYRD. I thank the Chair.
  Mr. President, I ask unanimous consent that I may speak out of order 
for as long as I may require.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. BYRD. Mr. President, I thank the Chair.

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