From: MoMayrides@aol.com Sent: Monday, August 16, 2004 3:40 PM To: fdadockets@oc.fda.gov Subject: Comments from AAFA - FDA Docket No. 2003P-0029 August 16, 2004 Lester M. Crawford, DVM, PhD Acting Commissioner US Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 Re: Docket No. 2003P-0029: Use of Ozone Depleting Substances; Removal of Essential-Use Designations Dear Dr. Crawford: I am writing on behalf of the Asthma & Allergy Foundation of America (AAFA) in response to the Food and Drug Administration’s (FDA) proposed rule in the June 16, 2004 US Federal Register concerning removal of the essential-use designations for albuterol used in oral pressurized metered-dose inhalers (MDIs). AAFA, a not-for-profit organization founded in 1953, is dedicated to improving the quality of life for people with asthma and allergies through education, advocacy, and research. AAFA sincerely appreciates the FDA’s careful analysis of the implications of a transition to chlorofluorocarbon-free (CFC-free) MDIs. AAFA is a member of and signatory to the comments submitted separately on this proposed rule by the US Stakeholders Group on MDI Transition (US Stakeholders). As such, our comments will not repeat what has been submitted by the US Stakeholders. Moreover, like the US Stakeholders, we will not recommend a specific transition date, believing instead that albeit a complex issue, an exact date is largely an administrative and technical matter to be resolved with continued and appropriate FDA analysis as the agency develops a final rule for transition. Instead, AAFA appreciates this opportunity to emphasize some key points we believe to be fundamental in the decision-making process. First, concerning the “inelasticity of prescription drug purchases with respect to price changes” (US Federal Register, pg. 33607), we would like the FDA to consider further that many asthma patients are affected by a number of co-morbid conditions sometimes requiring a host of medications in addition to routine prescriptions for diagnosed asthma. Thus, it is possible that many patients faced with higher prices for their albuterol MDIs may forego additional and necessary medicines for allergic rhinitis or reflux disease, for example. It is also possible that due to the larger cumulative cost of care for all of their related conditions, patients may choose instead to forego important asthma medicines. In either case, having to choose among needed prescription medicines based on affordability will certainly have longer-term implications for overall health system costs and could severely diminish patients’ quality of life. Although an economic analysis may not be feasible at this time to quantify the potential effect of asthma and co-morbidity vis a vis transition to non-CFC albuterol MDIs, we put forth that at the very least, “elasticity” with regard to the patient’s burden of asthma treatment costs is a moving target worthy of further FDA consideration as it develops a final rule on this issue. Furthermore, the question of supply and demand elasticity is particularly acute for the FDA-estimated 400,000 to one million individuals who may be vulnerable to higher prices for MDIs. Although the gesture by manufacturers of providing free samples of non-CFC MDIs to physician offices is certainly welcome, we urge FDA to take this a step further by helping to ensure that any proposed subsidy programs for needed medicines target those most in need, particularly low-income children and minority populations. Second, AAFA would like to emphasize the issue of transition as a further opportunity to educate primary care physicians and patients on the appropriate management of asthma, which according to current national treatment guidelines from the National Asthma Education and Prevention Program (NAEPP) calls for less reliance on rescue albuterol MDIs and increased adherence to controller medicines, trigger-avoidance strategies, and consistent monitoring. As a final rule for transition is developed, we urge FDA to include in its rulemaking potential strategies for how organizations like AAFA, as well as all US Stakeholders groups and others may continue to contribute to this asthma education effort in concert with the relevant State and Federal authorities. We urge the FDA to address this important issue in more depth in the final rule. Again, AAFA very much appreciates the dedication of the FDA in its careful consideration of the many implications of a transition to non ozone-depleting albuterol MDIs. On behalf of patients, we look forward to continuing our work with the FDA and with all stakeholders to ensure an orderly and transparent transition. If you have any questions concerning these comments, please contact Mo Mayrides, AAFA Director of Public Policy, at (202) 466-7643 x273. Sincerely, C. Ben Hadden President, AAFA (submitted electronically by Mo Mayrides (momayrides@aol.com) on behalf of C. Ben Hadden)