Economic Issues Raised in the FDA’s Proposed Rule on Removing the Essential-Use Designation for Albuterol MDIs
13 August 2004
By Dr. Richard Rozek et al.
On 10 June 2004, the US Food and Drug Administration (FDA) convened a meeting of the Pulmonary-Allergy Drugs Advisory Committee to discuss designating albuterol chlorofluorocarbon (CFC) metered-dose inhalers (MDIs) as non-essential, which would eliminate the products from sale in the U.S. While used by asthma and COPD patients for more than 20 years, the CFC propellant had been identified as an environmentally harmful ozone depleting substance, and thus is to be phased out as part of an international accord once sufficient alternatives are available. At the meeting, NERA Special Consultant Dr. Richard Rozek presented information on the cost impact to patients and payers of this policy change. Subsequently, the FDA published a Notice of Proposed Rulemaking (NOPR) in the Federal Register requesting comments on several issues related to the marketplace for albuterol MDIs to determine if patients will be adequately served by existing albuterol hydrofluoroalkane (HFA) MDIs after it removes the essential-use designation for albuterol CFC MDIs.
In response to this request, a NERA team submitted comments on the economic impact of the policy change. Specifically, the authors updated their prior analyses to reflect new information on the relationship between the magnitude of co-payments and use of certain pharmaceutical products, upcoming prescription drug coverage for Medicare enrollees, and additional commitments by manufacturers to provide free samples, distribute discount coupons, freeze prices, and participate in patients' assistance programs. They compared their prior results to the information presented in the NOPR and correct misconceptions in the NOPR that result in estimates that substantially overstate the cost of the policy change. Finally, the authors provided empirical evidence to suggest that the two existing suppliers of albuterol HFA MDIs are likely to compete aggressively after the phase out of albuterol CFC MDIs.
Dr. Rozek and Ms. Bishko conclude that the economic evidence supports a near-term effective date for the FDA to remove the essential-use designation for albuterol CFC MDIs and that all patients will continue to be adequately served after the policy change. They suggest that the FDA should adopt a December 31, 2005 date as the effective date for withdrawing albuterol CFC MDIs from sale in the U.S.
