Correspondence

Albuterol Inhalers

N Engl J Med 2007; 356:2749June 28, 2007

Article

To the Editor:

In response to the review article by Hendeles et al. about the withdrawal of albuterol inhalers containing chlorofluorocarbon (CFC) propellants (March 29 issue),1 although we all agree that the eventual elimination of CFC use is an important step for the planet, it has led to serious problems for uninsured and underinsured patients with airways disease. Albuterol metered-dose inhalers containing a hydrofluoroalkane (HFA) propellant, being branded, cost two to three times as much as albuterol inhalers containing a generic CFC, adding perhaps $25 monthly to a patient's medication costs.2 Many patients have turned to less expensive over-the-counter alternatives such as epinephrine and metaproterenol. The amount of CFCs used for medical inhalers is microscopic as compared with the 150,000 tons of CFCs used for a variety of industrial purposes in 2004.3

I accept my share of the blame for the added cost, because I was a member of the advisory committee of the Food and Drug Administration (FDA) that voted in 2005 in favor of the FDA's Final Rule on Albuterol, which stated that the production and sale of single-ingredient albuterol CFC metered-dose inhalers must stop by the end of 2008. At that time, the effect of the higher costs of branded HFA albuterol was not adequately understood; I now believe it would be appropriate, if possible, for the FDA to make a temporary exception in the case of CFC-containing albuterol inhalers until the first patent for HFA albuterol expires in 2010.

Nicholas J. Gross, M.D., Ph.D.
Stritch–Loyola School of Medicine, Maywood, IL 60153
nicholas.gross@med.va.gov

Dr. Gross reports receiving research grants, consulting fees, and speaking honoraria from Pfizer, Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, Dey, and Almirall. No other potential conflict of interest relevant to this letter was reported.

3 References

1. 1

   Hendeles L, Colice GL, Meyer RJ. Withdrawal of albuterol inhalers containing chlorofluorocarbon propellants. N Engl J Med 2007;356:1344-1351
   Full Text | Web of Science | Medline

2. 2

   Food and Drug Administration. Use of ozone-depleting substances: removal of essential use designations; final rule. Fed Regist 2005;70:17167-17192
   Medline

3. 3

   United Nations Environment Programme home page. (Accessed June 7, 2007, at http://unep.org.)
   

Author/Editor Response

Gross raises concerns about the economic effect of the phase-out of CFC albuterol metered-dose inhalers, arguing for a significant delay. These concerns were considered throughout the public rulemaking process.1,2 If there were no specified withdrawal date or if the date were much delayed, manufacturers of HFA albuterol products would not have increased their production capacity until much later. Yet the availability of pharmaceutical-grade CFCs is rapidly declining and even the supply of necessary parts for CFC albuterol inhalers is becoming an issue. Therefore, a delay could pose the serious risk of a precipitous interruption in the availability of CFC albuterol inhalers that could not be offset by HFA albuterol metered-dose inhalers, since production capacity cannot be quickly increased. A predictable, orderly phase-out process is critical to prevent this outcome, even in the face of increased costs to patients. Finally, there are efforts to offset the economic effect of this transition for vulnerable patients, such as the increased availability of free samples of HFA albuterol and patient-assistance programs.3

Robert J. Meyer, M.D.
Food and Drug Administration, Silver Spring, MD 20993

Leslie Hendeles, Pharm.D.
University of Florida, Gainesville, FL 32610
hendeles@cop.ufl.edu

Gene L. Colice, M.D.
Washington Hospital Center, Washington, DC 20010

3 References

1. 1

   Food and Drug Administration. Pulmonary-Allergy Drugs Advisory Committee Meeting, June 10, 2004. (Accessed June 7, 2007, at http://www.fda.gov/ohrms/dockets/ac/04/slides/2004-4048s1.htm.)
   

2. 2

   Use of ozone-depleting substances; removal of essential-use designations: Final Rule. Federal Regist 2005;70:17167-17192http://www.fda.gov/OHRMS/DOCKETS/98fr/05-6599.htm
   Medline

3. 3

   Partnership for Prescription Assistance home page. (Accessed June 7, 2007, at https://www.pparx.org/Intro.php.)