Regulatory Focus: FDA Bans Metered-Dose Albuterol Inhalers Containing CFCs
Final rule calls for elimination of ozone-depleting products by late 2008.
Ben Van Houten
FDA and the U.S. Department of Health and Human Services (HHS) have published a final rule that outlaws any production of albuterol metered-dose inhalers (MDIs) con- taining chlorofluorocarbon (CFC) propellants. The rule, recently published in the Federal Register, states that any MDI that uses a CFC propellant can no longer be produced, marketed, or sold in the United States after December 31, 2008.
The rule also says that sufficient supplies of two approved, environmentally- friendly albuterol inhalers are expected to be on the market by that date, a fact that should reassure patients who have expressed concern that the medicines they need to treat their asthma or chronic obstructive pulmonary disease will be off the market. “FDA has developed a regulatory strategy to ensure that patients in the United States who rely on MDIs for their health and well-being have continuing access to an array of safe and effective treatment options,” writes the agency on its Web site.
More specifically, the rule forms the basis for the phaseout of the CFC-containing albuterol products through the withdrawal of their essential-use status as of the 2008 date. According to HHS, this change in status is based on the agency’s 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 containing 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.
• 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.
Prior to this final rule, HHS sought and received public comment from its June 2004 proposed rule. This public comment, along with feedback from a Pulmonary Allergy Drugs Advisory Committee meeting the same month, helped the agency with its development of the final rule, according to FDA.
MDIs containing CFC were previously exempted from a general ban of CFC production and importation under an international agreement established though the Montreal Protocol on Substances that Deplete the Ozone Layer and the U.S. Clean Air Act.
In the final rule, HHS also writes that it is supportive of the manufacturers of three environmentally-friendly albuterol inhalers, all of which are implementing programs to help assure access to these MDIs for patients with cost concerns. Some of these programs include MDI giveaways, coupons for reducing the price paid, and patient-assistance programs that are based on financial need.
More information on the rule can be found at www.fda.gov/cder/mdi/default.htm.