[Congressional Record Volume 143, Number 157 (Sunday, November 9, 1997)]
[Extensions of Remarks]
[Page E2283]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




           PRESERVING PATIENT ACCESS TO METERED DOSE INHALERS

                                 ______
                                 

                       HON. CHRISTOPHER H. SMITH

                             of new jersey

                    in the house of representatives

                       Saturday, November 8, 1997

  Mr. SMITH of New Jersey. Mr. Speaker, when most of us think about the 
Food and Drug Administration [FDA], we envision an agency that works 
diligently to expand the universe of safe and effective medications. So 
when I discovered that the FDA was actually proposing to reduce the 
number of proven medicines available to treat asthma and cystic 
fibrosis patients, I knew Congress had to act on behalf of patients. As 
a legislator representing thousands of asthma patients, and as a father 
of two daughters with asthma, I am appalled that FDA might ban proven 
medicines patients need to survive.
  As a result of these efforts by the FDA, today I am introducing 
legislation that will preserve access to metered dose inhalers [MDIs] 
for those patients suffering from respiratory conditions--particularly 
children suffering from asthma and cystic fibrosis. This bill will 
ensure that those who rely upon MDI's to breathe, will not be denied 
access to their lifeline by an overzealous FDA. Joining me in this 
effort is my good friend Florida, Representative Cliff Stearns. 
Together, Mr. Stearns--who is the author of H.R. 2221--and I have 
worked together in an effort to change the FDA's misguided policy.
  On March 6, 1997, the FDA initiated the first stage of a plan to 
phase-out the use of chlorofluorocarbons [CFC's] metered-dose inhalers 
[MDI's], which are used by asthma and cystic fibrosis patients to 
breathe. This action was taken ostensibly to protect the ozone layer, 
despite the fact that less than 1 percent of all ozone-depleting 
substances in the atmosphere are caused by metered-dose inhalers.
  In fact, the amount of CFC's that the EPA allows to be released from 
automobile air conditioners over 1 year is about the same as 14 years 
of metered-dose inhaler emissions. If you combined all sources of CFC's 
allowed by the EPA in 1 year, it would equal 64 years of MDI emissions. 
And yet the only CFC products targeted for elimination this year are 
inhalers.
  It is also interesting to note that while the FDA and EPA are rushing 
to eliminate CFC inhalers, they continue to allow the use of a variety 
of CFC products, including bear-repellent pepper sprays, document 
preservation sprays, and certain fire extinguishers. This is clearly a 
case of misplaced priorities--how can historical document sprays be 
considered more essential than products that protect our children's 
lives? And while American children and senior citizens will have their 
treatment regimens disrupted by the FDA's plan, nations like China and 
Indonesia will be pumping tons of CFC's into the atmosphere from hair 
sprays and air conditioners until the year 2010.
  Not surprisingly, the FDA's plan has generated a firestorm of 
opposition from patients, respiratory therapists, and physicians: 
nearly 10,000 letters in opposition have been received to date by the 
FDA. A coalition of stakeholder organizations reviewed the FDA proposal 
in May and concluded that the FDA's approach banning therapeutic 
classes was flawed and must be re-evaluated. The patient and provider 
organizations also stated that the FDA plan ``has the potential to 
disrupt therapeutic regimens * * * and limit physician treatment 
options.''
  It is important to institute a transition strategy that will 
eventually eliminate the use of CFC's. However, the FDA's proposal is 
deeply flawed and should be scrapped in favor of a plan that puts 
patients--not international bureaucrats--first.
  To ensure that the interests of patients are upheld throughout the 
formation of our country's MDI transition strategy, this legislation 
will temporarily suspend the FDA's proposed framework until a new 
proposal can be crafted. In addition, this bill would require the FDA 
to consult with patients, physicians, manufacturers of MDI's and other 
stakeholders prior to issuing any subsequent proposal. In addition, my 
legislation requires the Secretary of Health and Human Services to 
certify to Congress that any alternatives to existing MDI's will be 
available to all populations of users of such inhalers, are comparable 
in terms of safety and effectiveness, therapeutic indications, dosage 
strength, cost, and retail availability.
  Mr. Speaker, this past week we held a press conference in an effort 
to educate the public and media about the dangers of the FDA's 
proposal. Participating in this press conference was Tommy Farese, who 
is 9 years old, and lives in Spring Lake, NJ, and has had asthma since 
the age of 2. One of the asthma inhalers Tommy uses to breathe--
Proventil--would be eliminated under the FDA plan in favor of a non-CFC 
version that has not been approved by the FDA for use by children. 
Unless the FDA's proposal is changed, Tommy could lose access to the 
medicine he needs to breathe and live. Why should Tommy, and 5 million 
children like him have to face this dilemma?
  In my view, any plan to remove safe and effective medications from 
the marketplace needs to place the interests of children like Tommy 
Farese first and foremost. Sadly, the FDA plan fails in this regard. 
Indeed, the FDA plan presumes that CFC-free inhalers serve all patient 
subpopulations--such as children and the elderly--equally well, despite 
the fact that children have special needs and many drug therapies are 
not interchangeable.
  Therefore, I call upon the FDA to stop their proposed ban of asthma 
inhalers. If the FDA insists on moving forward with their antipatient 
plan, I call upon my colleagues to support and pass the Smith-Stearns 
bill to allow asthma patients like Tommy Farese retain access to their 
medicine.

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