Nancy Sander, founder and president of AANMA, testified during the Food and Drug Administration (FDA)’s open public hearing segment of the March 10-11 meeting of the Joint Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee.Here’s Nancy’s speech:
“My name is Nancy Sander. I am president and founder of Allergy & Asthma Network Mothers of Asthmatics, the only national nonprofit organization whose sole mission is to eliminate death and suffering due to asthma, allergies and related conditions. I have 25 years of award-winning service to families. I have asthma, as do three of my four grown children.
Disclosure: I paid my way here. We do not sell our logo, endorse or certify products or companies or engage in litigation. Additional disclosure information is attached.
Allergy & Asthma Network Mothers of Asthmatics (AANMA) strongly opposes FDA’s recommended label changes for long-acting bronchodilators as they are premature, based on a single study not intended for the purpose of identifying asthma deaths, and will prejudice all future studies and use of an entire class of medications shown to benefit patients nationwide.
We also take exception with FDA’s demands to reduce the number of canisters dispensed, as if we and our physicians are incapable of making decisions about risk, impairment and appropriate therapy based on NIH Asthma Guidelines.
Regardless, FDA’s proposed label — “WARNING: ASTHMA DEATHS” — is likely to have the prescription dampening results the agency seeks as fear-ridden patients, prescribers and insurers abandon what FDA says is killer therapy.
These are frightening times for patients. On one hand, FDA warns long-acting bronchodilators are dangerous and orders us to use less of them while on the other, FDA orders manufacturers to recruit us and our children for additional studies.
It seems FDA put the cart before the horse. Shouldn’t the studies come first and label changes second? My daughter participated in a 14-month drug study program 27 years ago. It changed our lives and was the reason I founded AANMA in 1985.
But the study drug wasn’t labeled “WARNING: ASTHMA DEATHS.” If it had been, I would not have enrolled her in the study and I don’t know if she would be alive today.
We acknowledge the importance of safety studies, but FDA’s proposed label is going to make it difficult to recruit study subjects of any age.
FDA’s warning doesn’t belong on the drug, it belongs on the disease! Ten people die of asthma every day. We talk with many families whose loved one has died. None ever blame the medication.
But will FDA’s proposed label changes spur a new round of trial lawyer ads seeking damages for LABA victims?
Asthma deaths happen when people underestimate asthma’s insidious propensity to rob the body of oxygen as inflammatory cells rupture and release toxic fluids into mucus plugged airways.
Asthma death rates are declining at a time when long-acting bronchodilator use and adoption of Asthma Guidelines are at an all time high.
FDA was an integral part of NIH Asthma Guidelines development, evaluation, review and approval process for all pharmacotherapeutic recommendations. There have been no new clinical peer-reviewed studies to justify FDA’s drastic actions.
Ironically, the BADGER study recently confirmed long-acting bronchodilators as appropriate add-on to inhaled corticosteroids in children and adolescents when symptoms are not well controlled with low-to-medium dose inhaled corticosteroids alone. This finding is consistent with NIH Asthma Guidelines recommendations for adults.
All asthma medications have risks. So in formulating study design, remember that medications are only one part of what must be a comprehensive action plan developed in consideration of relevant allergens, irritants and secondary and/or coexisting conditions. The goal is to use the least amount of medication necessary to achieve maximum results.
We strongly urge FDA to make no new label changes until after study results have been evaluated — lest we find ourselves back in the dark ages of medicine.”
Related posts:
- Talk to your healthcare provider about FDA 12-hour bronchodilator warnings
- FDA Confirms New Label Language for Medications Containing Long-Acting Beta Agonists (LABAs)
- AANMA Provides Commentary to FDA Advisory Committees
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