Helping patients breathe more easily with affordable prescriptions Presented to Pulmonary-Allergy Advisory Committee U.S. Food and Drug Administration June 10, 2004 ATC Asthma Therapy Coalition

FDA is charged with protecting America’s health n FDA must base essential use decisions on facts and economic realities n A transition away from access to affordable rescue inhalers cannot ignore dire medical needs ATC Asthma Therapy Coalition

Asthma is on the rise n One of the most chronic and fastest growing diseases in America o 20 million asthmatics in o >1.9 million ER visits for asthma in 2002  Albuterol is an integral part of the management of asthma 2 1 Trends in Asthma Morbidity and Mortality, American Lung Association, Epidemiology & Statistics Unit, Research and Scientific Affairs (April 2004) 2 National Asthma Education and Prevention Program, available at /asthma/execsumm.pdfwww.nhlbi.nih.gov/guidelines /asthma/execsumm.pdf ATC Asthma Therapy Coalition

Asthma is on the rise [continued] n Disproportionate increase in the poorest and most cost-sensitive segments of society oUninsuredo Medicaid oUrbano Rural oChildreno Elderly on fixed incomes oMinorities n Recent JAMA study reveals that doubling co-payments decreases drug use by 32% 3 ATC Asthma Therapy Coalition 3 Goldman, Dana P., et al., Pharmacy benefits and the use of drugs by the chronically ill, JAMA V.291(19):

Medical/financial cost would far exceed environmental benefit n Generic CFC albuterol MDIs retail for more than $20 less than brand alternatives 4 n Removal of generics would raise treatment costs by $500 million annually, totaling ~$5 billion until HFA inhalers come off patent 4 ATC Asthma Therapy Coalition

Near-term environmental impacts are negligible n It will take 50 years for stratospheric chlorine loading to reach adequate levels to improve the environment n Even if all CFC albuterol MD products were eliminated this year, the environmental benefit would be insignificant ATC Asthma Therapy Coalition

FDA cannot undermine Hatch-Waxman n Pharma market progresses from brand exclusivity towards generic competition, not vice versa n Barring entry of generic alternatives for nearly a decade would represent an abrogation of FDA’s mandate to promote affordability by promoting competition 5 5 See Mark B. McClellan, M.D., Ph.D., FDA Commissioner, speech before Food and Drug Law Institute (Apr. 1, 2003) ATC Asthma Therapy Coalition

Questions begging for answers n Given the price sensitivity to Rx drug use, what will be the ripple effect throughout the health care system and is this acceptable? u Increased hospitalizations u Increased ER visits u Increased morbidity/mortality n Which groups will be most likely affected and how can this be prevented? u How successful will the currently proposed government and/or private sector programs be? n What direct environmental and patient benefits are gained by eliminating CFC-albuterol before generic alternatives may enter the market? Asthma Therapy Coalition ATC