Legislation Would Sink EPA/FDA Ban on Asthma Inhalers

Legislation Would Sink EPA/FDA Ban on Asthma Inhalers
December 1, 1997



A bipartisan effort is underway in Congress to snuff out an administration proposal that would ban most types of asthma inhalers. Lawmakers fear the EPA/FDA initiative could leave as many as 30 million American asthma sufferers without a means to help them breathe.

In March, the FDA quietly issued an advanced notice of proposed rulemaking that sets in motion a process designed to take chlorofluorocarbon-powered inhalers out of the hands of asthma patients. The move is part of EPA's plans, anchored in the Montreal Protocol of 1987, to ban the use of all CFCs. CFCs are suspected by some scientists to be responsible for depleting the Earth's protective ozone layer.

While the scientific debate over the effect of CFCs on the ozone layer has never been put to rest, the regulatory framework established to address the alleged problem has taken on a life of its own.

The administration's move has triggered outrage among asthma sufferers and prompted a decisive response from Capitol Hill. Sen. Tom Hutchison (R-Arkansas) and Rep. Mark Foley (R-Florida) have introduced legislation aimed at halting the EPA/FDA plans. The "Asthma Inhaler Regulatory Relief Act of 1996" (AIRR Act) would prohibit the agencies from eliminating CFC-containing asthma inhalers until the agencies can jointly certify to Congress that the replacements are comparable in their effectiveness, retail availability, and cost. Today, the alternatives to CFC-driven devices are often not as effective and can produce many unpleasant side effects.



"Responsibility to Preserve Access"

"If Congress does nothing and allows EPA and FDA to ban these life-saving devices, millions of Americans suffering from respiratory diseases will be placed at risk," Foley wrote his colleagues shortly before Congress adjourned for the year. "We have a responsibility to preserve access to the medicines that asthmatics and others with respiratory conditions currently depend on to maintain their lives."

The Hutchison/Foley legislation could not be acted on before Congress left for the year. It is expected to be taken up in January, and Congressional sources in both parties predict the legislation, with some modification, will likely pass next year. "Nobody's going to take an asthma inhaler out of the hands of children in an election year," one Republican staffer told Environment News.

The inhaler affair has been embarrassing to EPA, where the initiative to ban CFC-powered products originated. In mid-September the agency, with much fanfare, held a two-day conference on the environmental threats facing children. Now the agency is being made to explain why tiny asthma inhalers pose such a threat to the ozone layer that they should be taken out of the hands of people, including children, who need them.