Home Health & Hospice Week

FDA bans some inhalers containing ozone-depleting chemicals.

Over the next three years, durable medical equipment suppliers and the patients they serve will have to switch from albuterol metered-dose inhalers containing chlorofluorocarbon propellants to more environmentally friendly MDIs.

That's because albuterol MDIs containing CFCs will no longer be produced, sold or marketed in the United States after 2008.

The Food & Drug Administration announced the coming ban in a final rule published in the March 31 Federal Register. The move comes after the agency determined that sufficient supplies of environmentally friendly albuterol inhalers would exist by the time the ban takes effect.

3M and Schering Plough's Proventil HFA and GlaxoSmithKline's Ventolin HFA use the hydrofluoroalkane HFA-134a as a propellant in place of CFCs. IVAX Corp. also recently began marketing an albuterol HFA MDI, but the FDA is not officially considering that product as an alternative for the purposes of this rulemaking due to the short period of time it's been available. In addition, the FDA last month approved Sepracor's levalbuterol tartrate MDI Xopenex HFA.

In comments submitted to the FDA, 3M/Scher-ing and GSK said they both anticipated having the capacity to produce 30 million albuterol HFA MDIs annually by the end of this year.

The three-year transition time under the rule should allow sufficient time for suppliers to deplete their stock, the agency notes.

Advocates for people with breathing disorders praised the FDA's decision.

"The American Lung Association supports this because it's good for the environment," says the ALA's Norman Edelman. "There are substitutes available, so the ban should not have any deleterious effect."

Some comments submitted on the proposed rule raised concerns about affordability, since HFA MDIs are more expensive. Albuterol HFA inhalers currently retail for about $20 more than generic albuterol CFC MDIs.

However, the FDA believes purchasing assistance programs offered by Schering and GSK will ensure the products are available to low-income people. In addition, GSK has committed to a price freeze on Ventolin HFA until Dec. 31, 2007.

Greater expense will result in decreased utilization of the products, the FDA acknowledges. "Taking into account GSK's commitment to provide free samples and coupons, we estimate that higher prices due to the elimination of generic competition will reduce thenumber of MDIs sold by between 300,000 and 900,000 per year," the FDA states in the rule.

Ban Exempts Combivent

Albuterol MDIs historically have contained the CFCs trichlorofluoromethane and dichlorodifluoromethane. When released into the atmosphere, these chemicals release chlorine atoms, which deplete the ozone layer protecting the earth from solar radiation.

In 1978, the Environmental Protection Agency banned the use of CFCs as propellants in aerosol containers but made a few exceptions for essential uses, including "[m]etered-dose andrenergic bronchodilator human drugs for oral inhalation."

Then in 1989, the United States signed the Montreal Protocol on Substances That Deplete the Ozone Layer. In doing so, it made a commitment to reduce the production and consumption of certain CFCs.

The FDA has established an essential-use designation for metered-dose ipratropium bromide and albuterol sulfate in combination. The only product marketed under this designation is Boehringer Ingelheim Pharmaceuticals' Combivent, which will maintain its essential-use status and not be covered by the ban.

Educators wanted: Informing patients and health care providers about the switch from albuterol CFC MDIs to HFA MDIs will be very important, the FDA notes. It invites anyone interested in participating in a cooperative educational effort to contact the FDA or the Department of Health & Human Services.

Editor's Note: For more details on the FDA's rule, visit www.fda.gov/cder/mdi/.