[Congressional Record Volume 143, Number 142 (Tuesday, October 21, 1997)]
[House]
[Pages H8838-H8839]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




  FDA'S MISGUIDED POLICY COULD HARM PATIENTS WITH RESPIRATORY PROBLEMS

  The SPEAKER pro tempore. Under the Speaker's announced policy of 
January 21, 1997, the gentleman from Florida [Mr. Stearns] is 
recognized during morning hour debates for 5 minutes.
  Mr. STEARNS. Madam Speaker, on March 6, 1997, the FDA issued an 
advanced notice of proposed rulemaking, which set forth its plan to ban 
CFC-containing metered-dose inhalers once certain criteria are met. The 
plan was developed in collaboration with the Environmental Protection 
Agency and is intended to eliminate the minuscule amount of CFC's 
currently allowed to be used for medication delivered by metered-dose 
inhalers.
  CFC is the abbreviated term used to refer to chlorofluorocarbon gas. 
There are tens of millions of Americans who suffer from asthma; 5 
million of those are children. These patients depend upon CFC-propelled 
metered-dose inhalers to treat their asthma and to help them breathe. 
With over 5,000 deaths each year in America due to asthma, I am 
convinced that the FDA's rule would eliminate treatment options for 
asthmatic patients.
  Today, I want to talk about H.R. 2221, legislation that I, along with 
my colleague, the gentleman from New Jersey [Mr. Smith], introduced on 
July 22 of this year. Since that time I have received tremendous 
support from all over the country. With 28 cosponsors, the bill 
continues to receive new cosponsors daily. The bill would require the 
Secretary of Health and Human Services to take no further action on the 
FDA's proposed ban on CFC-containing metered-dose inhalers.
  My colleague, the gentleman from New Jersey [Mr. Smith], and I are 
working with Members from the House and Senate from the relevant 
committees in an effort to add language in the conference report to the 
Food and Drug Reform legislation. It will direct the FDA to withdraw 
its March 6, 1997, advanced notice of proposed rulemaking and to take 
no further action to promulgate a proposed final rule on the basis of 
such advanced notice.
  Madam Speaker, recently it has been pointed out in several leading 
publications, including the Wall Street Journal editorial dated 
September 17, 1997, that asthma is on the rise in our Nation. It is the 
most common chronic illness affecting children. In fact, among 
children's chronic diseases, asthma is the No. 1 reason for school 
absenteeism. Asthma mortality is also on the rise. Explanations for the 
increasing prevalence, morbidity and mortality are varied. Regardless, 
these populations include children, especially poor children living in 
urban areas.
  Are not these the very children that the EPA claims it is helping 
with its new air quality standards? This misguided policy is definitely 
the case of one hand not knowing what the other hand is doing.
  With one hand, the EPA presents new air quality standards that are 
supposed to protect the health of asthmatic children, while on the 
other, the FDA proposes to ban life-saving metered-dose inhalers from 
the market. The result of these actions would be to deny these children 
the treatment to help them to lead almost normal lives.
  Madam Speaker, I urge my colleagues on the conference to adopt the 
language that I have presented and outlined in their final report. I 
urge my

[[Page H8839]]

colleagues to support our bill, H.R. 2221, by becoming a cosponsor.

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