[Congressional Record Volume 143, Number 155 (Friday, November 7, 1997)]
[Extensions of Remarks]
[Pages E2213-E2214]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 FDA'S ``DOUBLE STANDARD'' ON CFC INHALERS COULD LEAVE ASTHMA PATIENTS 
                            GASPING FOR AIR

                                 ______
                                 

                       HON. CHRISTOPHER H. SMITH

                             of new jersey

                    in the house of representatives

                       Thursday, November 6, 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 
medicines patients need to survive.
  On March 6, 1997, the FDA initiated the first stage of a plan to 
phase-out the use of chlorofluorocarbons [CFC's] in 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 conditions over 1 year is about the same as 14 years of 
metered-dose inhaler emissions. If you combined all sources of CFCs 
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, Mr. Speaker, that while the FDA and 
EPA are rushing to eliminate CFC inhalers, they continue to allow the 
use of variety of CFC products, including bear-repellent pepper sprays, 
document preservation sprays, and certain fir 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clearly a case of misplaced priorities--how can historical document 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 fire storm 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, my colleague and 
friend from Florida, Congressman Cliff Stearns  and I introduced 
legislation--H.R. 2221--that will temporarily suspend the FDA's 
proposed framework until a new proposal can be crafted. We have also 
urged the conferees working on the FDA reform bill--H.R. 1411--to 
include legislative language protecting the rights of 30 million 
respiratory patients to maintain access to the medications they need to 
survive.
  Earlier today, I was honored to meet Tommy Farese. Tommy, who is 9 
years old, and lives in Spring Lake, NJ., 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

[[Page E2214]]

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 kids 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.
  Mr. Speaker, I call upon the FDA to stop their proposed ban of asthma 
inhalers and put forward a new proposed rule only after Congress 
reconvenes. In addition, I urge the conferees to H.R. 1411 to include 
legislative language that will stop the FDA from implementing this 
terribly flawed and environmentally marginal proposal. If the FDA 
insists on moving forward with their antipatient plan anyway, Congress 
should debate and pass the Sterans-Smith bill--HR 221--to allow asthma 
patients like Tommy Farese retain access to their medicine.

                          ____________________