On Chlorofluorocarbon Bans and Inhaled Albuterol Prices

Thecompetingconcernsand interestsofboth individuals and society must be considered when establishing regulatory policy. In 2008, the US Food and Drug Administration (FDA) banned albuterol inhalers containing chlorofluorocarbons.Thisdecisionwasquestionedat the timebecause the chlorofluorocarbons emitted from inhalershavean insignificant effect onozoneandbecause of the anticipated costs of transitioning tohydrofluoroalkane inhalers for patientswith respiratorydisease.1With the ban, generically manufactured chlorofluorocarbon inhalers were discontinued, leaving only branded hydrofluoroalkane inhalers available for use, even though the main pharmacological ingredient inboth typesof inhalers (albuterol)hadbeen available invarious generic formulations since the 1990s. Jena and colleagues examine the consequences of the ban on privately insuredpatientswithasthma, finding that themeanoutof-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.