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Editor's Note
July 2015

On Chlorofluorocarbon Bans and Inhaled Albuterol Prices

JAMA Intern Med. 2015;175(7):1179. doi:10.1001/jamainternmed.2015.1696

The competing concerns and interests of both individuals and society must be considered when establishing regulatory policy. In 2008, the US Food and Drug Administration (FDA) banned albuterol inhalers containing chlorofluorocarbons. This decision was questioned at the time because the chlorofluorocarbons emitted from inhalers have an insignificant effect on ozone and because of the anticipated costs of transitioning to hydrofluoroalkane inhalers for patients with respiratory disease.1 With the ban, generically manufactured chlorofluorocarbon inhalers were discontinued, leaving only branded hydrofluoroalkane inhalers available for use, even though the main pharmacological ingredient in both types of inhalers (albuterol) had been available in various generic formulations since the 1990s. Jena and colleagues examine the consequences of the ban on privately insured patients with asthma, finding that the mean out-of-pocket prescription costs for albuterol increased by 50%, with a small decline in inhaler use but reassuringly no increased risk for emergency department visits or hospital admission.2 Left unanswered is how uninsured individuals with asthma are faring.

Whether banning chlorofluorocarbon inhalers will lead to any improvement in the environment is unclear. It is clear that the ban has increased health care costs and improved the bottom line of pharmaceutical companies that are making hydrofluoroalkane-based inhalers. Although albuterol inhalers have been in use for more than 30 years, pharmaceutical companies have used the chlorofluorocarbon ban as an opportunity to raise the price on inhalers from approximately $13 for a generic formulation to more than $50 today. When the FDA banned albuterol inhalers containing chlorofluorocarbons, it was “encouraged that the manufacturers of [these] products [were] implementing programs to help assure access … for patients for whom price could be a significant barrier to access to this important medicine.”3 However, in this unique situation, it would have made more sense to not ban chlorofluorocarbon inhalers until hydrofluoroalkane inhalers were available in generic formulations. This would have balanced the best interests of society and the best interests of individuals with respiratory disease, allowing the FDA to protect the environment without making inhalers that had been on the market for many years expensive and unaffordable for many.

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Conflict of Interest Disclosures: Dr Ross reported receiving research grant funding through Yale University from the US Food and Drug Administration to develop methods for postmarket medical device surveillance and from Medtronic and Johnson & Johnson to develop methods for clinical trial data sharing. No other disclosures were reported.

References
1.
Hendeles  L, Colice  GL, Meyer  RJ.  Withdrawal of albuterol inhalers containing chlorofluorocarbon propellants. N Engl J Med. 2007;356(13):1344-1351.PubMedArticle
2.
Jena  AB, Ho  O, Goldman  DP, Karaca-Mandic  P.  The impact of the US Food and Drug Administration chlorofluorocarbon ban on out-of-pocket costs and use of albuterol inhalers among individuals with asthma [published online May 11, 2015]. JAMA Intern Med. doi:10.1001/jamainternmed.2015.1665.
3.
U.S. Food and Drug Administration. Questions and answers on final rule of albuterol MDI’s. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm080446.htm. Accessed February 13, 2015.
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