A Medical Device Daily

The FDA last week issued a final rule phasing out the use of albuterol metered-dose inhalers (MDIs) using chlorofluorocarbon (CFC) propellants. These types of devices can no longer be "produced, marketed or sold" in the U.S. after Dec. 31, 2008, the final rule says.

But those with asthma and similar lung illnesses can breathe easily, the FDA said.

Published Thursday in the Federal Register, the Department of Health and Human Services (HHS; Washington), the umbrella organization of the FDA, said sufficient supplies of "two approved, environmentally friendly albuterol inhalers," offering alternatives to the CFC propellant inhalers, will exist by Dec. 31, 2008, thus allowing the phase out of "similar, less environmentally friendly" versions.

HHS said it is "encouraged" that manufacturers of the non-CFC inhalers are developing programs to assure access to these albuterol MDIs "for patients for whom price could be a significant barrier to access to this important medicine. These programs include MDI giveaways, coupons for reducing the price paid and patient-assistance programs based on financial need."

CFC-containing albuterol MDIs, as with other CFC-based MDIs for asthma and chronic obstructive pulmonary disease (such as emphysema and chronic bronchitis), were previously exempted from a general ban of CFC production and importation under an international agreement established through the Montreal Protocol on Substances that Deplete the Ozone Layer and the U.S. Clean Air Act.

The final rule also forms the basis for the phase-out of the CFC-containing albuterol products through the withdrawal of their "essential use" status as of Dec. 31, 2008. HHS said that the change in status is based on four factors:

• At least two non-CFC products, with the same active drug are marketed the same route of administration, for the same indication, and with approximately the same level of convenience of use as the CFC product that contains that active ingredient;

• Supplies and production capacity for the non-CFC product will exist, and at sufficient levels, by Dec. 31, 2008, to meet patient needs;

• Adequate U.S. post-marketing use data are available for the non-CFC product;

• And patients who must use the CFC product for medical reasons will be adequately served by the non-CFC product and other available products.

HHS said it developed the final rule as the result of receiving public comment from a proposed rule in June 2004, feedback from a Pulmonary Allergy Drugs Advisory Committee meeting in June 2004, and consultation with other federal agencies.