# Presentation: 419808

## Helping patients breathe more easily with affordable prescriptions

Presented to
Pulmonary-Allergy Advisory Committee
U.S. Food and Drug Administration
June 10, 2004

**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

**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 **

- ATC

**Asthma Therapy Coalition**

## Asthma is on the rise

**One of the **_**most chronic**_** and **_**fastest growing**_** diseases in America**
**20 million asthmatics in 2002****1**
**>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 _[www.nhlbi.nih.gov/guidelines /asthma/execsumm.pdf](http://www.nhlbi.nih.gov/guidelines%20/asthma/execsumm.pdf)__ _

- 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**

- 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):2344-50.

## Medical/financial cost would far exceed environmental benefit

**Generic CFC albuterol MDIs retail for more than $20 less than brand alternatives****4**
**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

- 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 **

- ATC

**Asthma Therapy Coalition**

## FDA cannot undermine Hatch-Waxman

**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 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

**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?**

**Asthma Therapy Coalition**

- ATC