Asthma Therapy Coalition

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

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

3. ATC Asthma Therapy Coalition Asthma is on the rise • One of the most chronic and fastest growing diseases in America • 20 million asthmatics in 20021 • >1.9 million ER visits for asthma in 2002 • Albuterol is an integral part of the management of asthma2 1Trends 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 www.nhlbi.nih.gov/guidelines /asthma/execsumm.pdf

4. ATC Asthma Therapy Coalition Asthma is on the rise [continued] • Disproportionate increase in the poorest and most cost-sensitive segments of society • Uninsured o Medicaid • Urban o Rural • Children o Elderly on fixed incomes • Minorities • Recent JAMA study reveals that doubling co-payments decreases drug use by 32%3 3 Goldman, Dana P., et al., Pharmacy benefits and the use of drugs by the chronically ill, JAMA V.291(19):2344-50.

5. ATC Asthma Therapy Coalition Medical/financial cost would far exceed environmental benefit • Generic CFC albuterol MDIs retail for more than $20 less than brand alternatives4 • Removal of generics would raise treatment costs by $500 million annually, totaling ~$5 billion until HFA inhalers come off patent 4 http://www.drugstore.com/pharmacy/prices/drugprice.asp?ndc=00173032188&trx=1Z5006

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

7. ATC FDA cannot undermine Hatch-Waxman Asthma Therapy Coalition • Pharma market progresses from brand exclusivity towards generic competition, not vice versa • Barring entry of generic alternatives for nearly a decade would represent an abrogation of FDA’s mandate to promote affordability by promoting competition5 5See Mark B. McClellan, M.D., Ph.D., FDA Commissioner, speech before Food and Drug Law Institute (Apr. 1, 2003)

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