Two asthmatics in Congress say that a Food and Drug Administration plan to phase out ozone-depleting asthma inhalers could leave them and 18 million Americans gasping for breath.
“I’m an environmentalist,” said Rep. Patrick Kennedy, a Democrat from Rhode Island. “I am also an asthmatic. I know what it’s like to barely be able to catch my breath. Unfortunately for asthmatics like myself, the phase-out of the inhalers is a Catch-22.”
The phaseout would begin in 1999, but the FDA, which is proposing the rules, says that its procedures won’t kick in until suitable alternatives are available.
“If you’d look at our plan, you would see it’s remarkably reasonable,” FDA spokesman Don McLearn said. “There has always been a medical out.”
But Kennedy, along with Florida Republican Mark Foley, who suffered from asthma as a child, and Pennsylvania Reps. Ron Klink, a Democrat, and Jon Fox, a Republican, don’t want to take a chance. They introduced a bill Tuesday that would prohibit the government from banning the asthma inhalers until an equal number of comparable replacement drugs become available at similar cost to current products.
Most asthma inhalers now on the market contain chlorofluorocarbons, a chemical used to propel the medicine from the canister into the patient’s lungs. Inhalers are the preferred treatment for most of the 18 million Americans with asthma. Scientists have found that CFCs pose an environmental hazard because they deplete the ozone layer.
In 1987, the United States and more than 100 other countries agreed to gradually eliminate the use of CFCs. But that treaty made exceptions for medically necessary uses in which no alternatives could be found.
Asthma inhalers, which represent less than 1 percent of CFCs spewed into the atmosphere, fell into that category until January. At that time, 3M, a pharmaceutical company based in Minnesota, introduced a form of Proventil that used a new CFC-free propellant.
However, some patients have found the new inhaler less effective.
One of them was Karen Kasich, wife of Ohio Republican Rep. John Kasich.
“She found it difficult to use and wasn’t able to get the medicine into her lungs as quickly as the old inhaler,” said Kasich’s press secretary, Bruce Cuthbertson. “It just didn’t do the job.”
Patients who depend on the medication often go through much trial and error before finding a treatment that fits, said Nancy Sander, president of the Allergy and Asthmas Network/Mothers of Asthmatics Inc. in Fairfax, Va.
“If you’re going to tell me I have to change my medication, what are my alternatives? Each inhaler has its own characteristics,” said Sander, an asthmatic who uses a combination of three inhalers to control her breathing difficulties. “I want to know if it will work as quick as previous medications. Will it give me headaches or tremors? The FDA is acting prematurely.”
The FDA’s plan, announced in March, would treat CFC-type asthma inhalers as non-essential medicines. Before taking any category of drug off the market, the FDA would have to approve at least three alternatives that have the same medical effect, McLearn said. The agency would also have to determine that the manufacturer could meet the market demand and that patients accept the drug.
The proposed legislation is unnecessary, said Melissa Matosian, a lobbyist for the American Lung Association.
“As many as 30 CFC-free inhalers are expected to be launched by 2000, so there will be more than plenty,” Matosian said. “CFCs will not be around forever.”
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