FDA Ban on CFCs in Asthma Inhalers Raised Costs for Patients, New Study Finds

Regulatory NewsRegulatory News | 11 May 2015 | By

An environmental law which required the US Food and Drug Administration (FDA) to revoke the approval of products containing chlorofluorocarbons (CFCs) significantly raised the out-of-pocket expenses borne by patients with asthma, a new study published in the medical journal JAMA Internal Medicine.


In 1987, the US signed an environmental agreement known as the Montreal Protocol, an international agreement meant to preserve the ozone layer by phasing out the use of CFCs, which were then commonly used as propellants in aerosol canisters, including asthma inhalers.

Despite the Protocol's phase-out plan, it took until 2005 for FDA and the Environmental Protection Agency (EPA) to develop rules to implement the CFC phase-out for inhalation asthma products.

Under an April 2005 final rule, FDA revoked the "essential medicines" status of albuterol-based metered-dose inhalers (MDIs) containing CFCs. Prior to the rule, the "essential medicine" indication had shielded the CFC-containing albuterol MDIs from the Clean Air Act—the US law implementing the Montreal Protocol.

FDA's final rule argued suitable alternatives to CFC propellants existed and were being used "for the same indications and with approximately the same level of convenience of use." Accordingly, albuterol MDIs containing CFCs were no longer "essential" and were therefore subject to the Montreal Protocol.

The final rule prohibited any albuterol MDI from being marketed after 31 December 2008. The vast majority of companies complied, and modified their products to use a different propellant, hydrofluoroalkane (HFA).

Impact on Patient Access

While the Montreal Protocol may have worked as intended by taking a hard line against ozone layer-destroying CFCs, it had an unintended consequence as well, write the authors of a recent piece in JAMA Internal Medicine.

"The FDA ban on albuterol CFC inhalers was associated with large relative increases in out-of-pocket inhaler costs and slight declines in albuterol inhaler utilization among privately insured individuals with asthma," wrote Anupam Jena, Oliver Ho, Dana Goldman and Pinar Karaca-Mandic.

The group looked at a data set comprised of nearly 150,000 patients who were privately insured between 1 January 2004 and 31 December 2010.

The 2005 final rule, they noted, all but eliminated generic albuterol inhalers in favor of branded HFA inhalers. To this day, no HFA inhalers on the market have generic formulations, they said.

That lack of competition substantially increased out-of-pocket costs for the average patient, the study found. Between 2004 and 2006, the average out-of-pocket cost for a 30-day supply of albuterol was around $14. Between 2007 and 2010, out-of-pocket costs ranged between $18 and $25 for the same 30-day supply.

Perhaps more troubling, however, was a "modest decline" in albuterol inhaler utilization among the privately insured. The increased out-of-pocket costs, they said, had led to some patients to fill fewer prescriptions for albuterol inhalers. Their study did not find an increase in asthma-related hospitalizations, emergency department visits or outpatient visits, they said.

However, "Larger declines in use may also have occurred among the uninsured, for whom we did not have data," the authors hypothesized. "Prior research has demonstrated high rates of medication nonadherence among the uninsured, suggesting that albuterol inhaler utilization among uninsured patients with asthma may have been more adversely affected than observed in our privately insured population."

The effects of FDA's change on the uninsured "warrants further exploration," they concluded.


JAMA Internal


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