FDA Publishes Final Rule on Chlorofluorocarbons in Metered Dose Inhalers
The Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services (HHS), today announced that albuterol metered-dose inhalers (MDIs) using chlorofluorocarbon (CFC) propellants must no longer be produced, marketed or sold in the United States after December 31, 2008.
In a final rule published today in the Federal Register, HHS said sufficient supplies of two approved, environmentally friendly albuterol inhalers will exist by December 31, 2008 to allow the phasing out of similar less environmentally friendly versions.
HHS is encouraged that the manufacturers of three environmentally friendly albuterol inhalers are implementing programs to help 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 (which includes 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 December 31, 2008. This change in status is based on HHS' determination that:
- At least two non-CFC products with the same active drug are marketed with 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 by December 31, 2008 at levels sufficient to meet patient needs;
- Adequate U.S. post marketing use data are available for the non-CFC product; and
- Patients who are required to use the CFC product for medical reasons will be adequately served by the alternative non-CFC product and other available products.
HHS sought and received public comment from a proposed rule in June 2004. This public comment, combined with feedback from a Pulmonary Allergy Drugs Advisory Committee meeting in June 2004, as well as consultation with other Federal agencies, helped the agency develop the final rule.
For additional information, go to: http://www.fda.gov/cder/mdi/default.htm.