Because of a federal ban that took effect last year, millions of Americans with asthma and other pulmonary conditions were required to switch to rescue inhalers deemed better for the environment.
Now signs are surfacing that the environmentally friendlier inhalers – deemed suitable by the U.S. Food and Drug Administration but considered woefully inadequate by some inhaler users – might not be here to stay.
Those inhalers use hydrofluoroalkane, or HFA, in place of chlorofluorocarbons, or CFCs, to pump medicine to open the airways during an asthma attack. Sale of CFC albuterol inhalers in the U.S. was banned Dec. 31.
Industry insiders say they are looking for an alternative to HFA inhalers for the same reason CFC inhalers were banned: the propellantharms the environment.
The environmental argument has been criticized by many opposed to the CFC inhaler ban. Still, governmental officials say HFA inhalers contribute to global warming, although they stopped short of confirming plans for a ban.
Cathy Milbourn, a senior press officer with the U.S. Environmental Protection Agency, said the agency is “not aware of a ban or a push to ban” HFA rescue inhalers. She declined to speculate on whether such a ban might someday be implemented.
Christopher C. Kelly, an FDA media represenative, said “at this time, there is no plan to phase out HFA inhalers.”
At Honeywell Medical Products, work is well under way to formulate an alternative to HFA inhalers. The Morristown, N.J.-based company makes propellant for asthma inhalers and products for medical device sterilization and is a part of $37 billion conglomerate Honeywell International.
Honeywell Medical has been “working with individual pharmaceutical companies and the International Pharmaceutical Aerosol Consortium to develop low-global warming alternatives to HFA propellants,” Kekin Ghelani said.
IPAC is an association of companies that make inhalers and other products for treating respiratory diseases, and Ghelani is Honeywell Medical’s global business manager.
Developing an alternative to HFA is a tall order considering the industry’s struggles to find an alternative to CFC. Of 15,000 compounds reviewed before the CFC inhaler ban, according to an IPAC report, only HFCs, hydrofluorocarbons – known as HFA in their purified form – were considered a promising alternative.
Nor was making the CFC-to-HFA switch as simple as swapping out propellants, Ghelani said. The active ingredient, albuterol, had to be reformulated; new materials had to be used for the valve and canister; and other changes were made to ensure compatibility with the new propellant, he said.
As a result, inactive ingredients and impurities are different in the two types of inhalers. Arthur Abramson, who co-founded SaveCFCinhalers.org, believes those changes – not the albuterol itself – are to blame for the problems people have reported with HFA inhalers.
Despite those complications, another inhaler change could be on the horizon.
At an IPAC conference in September, pharmaceutical executive Paul J. Atkins spoke about climate change and HFA inhalers. Atkins is president and chief operating officer of North Carolina-based Oriel Therapeutics Inc., a specialty pharmaceutical company developing and commercializing products to improve respiratory care.
In comments captured in a slide show, he said most existing policies addressing climate change are aimed at minimizing emissions rather than phasing out HFAs. However, he said, “science and policy are evolving, and pressure will likely increase for bans.”
He referred to European legislation to ban HFAs in mobile air conditioning within the next five years and said alternatives are under development for all HFA sectors, including HFA inhalers.
An IPAC official said the organization opposes an outright ban of HFA inhalers. But Abramson contends that “IPAC wants the Copenhagen Treaty to ban HFA inhalers … They earned huge profits when the Montreal Protocol banned CFC inhalers and ordered the transition to HFA inhalers, and they’d love to do that again,” he said.
