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FDA Reviewing Safety of Asthma Drugs: Official AAFA Statement

Statement by AAFA President, Chris Ward to the Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC), Regarding Safety of Long-Acting Beta-Agonist Bronchodilators

Contact:      Angel Waldron at 202-466-7643, x248

WASHINGTON, July 13, 2005 -- Good afternoon. My name is Chris Ward. I am an asthma and allergy patient and current President of the Asthma and Allergy Foundation of America, or AAFA. We have not received payment from any entity for this testimony or for the cost of our travel and participation in this meeting today.

On behalf of the almost 20 million Americans with asthma, AAFA appreciates the opportunity to testify to this Advisory Committee concerning the safety of long-acting beta-agonist bronchodilators, or LABAs. Since 1953, AAFA has been dedicated to improving the quality of life for people with asthma and allergies. Patients, their families, and their caregivers turn to our organization for education, research, and advocacy.

AAFA appreciates the heightened vigilance at the FDA regarding drug safety and thanks the advisors for reviewing the available data and meeting today to discuss potential safety concerns with this class of drugs. Asthma, of course, is a treatment-intense condition for many patients and your advice to the Agency today will impact millions of individuals who depend on these products as part of their regimen for asthma control.

There are three key messages I would like to convey on behalf of patients with asthma.

First, as we understand it, there are no concerns with the efficacy of this class of drugs and their important role in asthma control, which is reflected in both the national and international guidelines for asthma clinical care that use the word “preferred” when recommending these products in conjunction with inhaled corticosteroids for moderate to severe persistent asthma. There is strong, consistent evidence from clinical trials that this approach leads to improvements in lung function and symptoms and reduces the need for short acting beta-agonists. When we weigh this evidence of effectiveness against the evidence of potential risk, which is at best still undefined, we believe it would be difficult for asthma patients to understand why these products would not continue to be available to them. 

Second, we believe there is an element of scientific and clinical progress in asthma that may be missing from this discussion. Mainly, there seems to be progress in the pharmacogenomic understanding of how the beta-agonists have different effects on different individuals. We believe the results of the government trial published last October demonstrating different responses to the short-acting beta-agonists based on genotype is an important step forward. We understand that a similar clinical trial is just now getting underway for the long-acting beta-agonists. In other words, and again, from the perspective of asthma patients, there is current and ongoing investigation into this important clinical question. We understand very well that a subset of patients may be at higher risk than others. But we are only beginning to understand why this is the case.  At this point in time, then, it would seem advisable to defer any conclusive decisions about the availability of these drugs to all patients until there are more definitive answers.

Third, with regard to the consideration of whether the labeling changes to salmeterol should be applied to formoterol, it is our position that FDA’s responsibility lies in working closely with the product sponsor to answer this question and to determine a product label that is consistent with available medical evidence. In fact, we are encouraged that both product sponsors are working closely with the Agency to further understand and clarify the nature and magnitude of potential risk of this class of drugs. We believe the safety of asthma patients should be front and center in this ongoing work.

In conclusion, we certainly urge all parties to continue this important discussion. However, AAFA believes that at this time there are too many questions to be able to draw conclusive decisions on medicines that have been effective for millions of patients to be able to control their asthma. Again, on behalf of these patients, I thank you for the opportunity to testify on this important issue. I’m pleased to answer any question you may have.

To speak with an AAFA representative about this statement or a related issue, contact Angel Waldron or 202-466-7643, x248.

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