From: Sharon Ifft [SIfft@aanma.org]
Sent: Tuesday, June 05, 2001 4:52 PM
To: 'fdadockets@oc.fda.gov'
Subject: 98P-0610

Attached is a submission from Allergy & Asthma Network Mothers of Asthmatics
for the Federal Register. Thank you.

 <<OTC Statement with Results.doc>> 

From: Sharon Ifft [SIfft@aanma.org]
Sent: Tuesday, June 05, 2001 4:52 PM
To: 'fdadockets@oc.fda.gov'
Subject: 98P-0610

Attached is a submission from Allergy & Asthma Network Mothers of Asthmatics
for the Federal Register. Thank you.

On Friday, May 11, a Food and Drug Administration (FDA) advisory panel recommended that prescription nonsedating antihistamines Claritin, Zyrtec, and Allegra be sold over-the-counter. The panel voted 19 to 4 to switch Claritin and Zyrtec to over-the-counter status and 18 to 5 for Allegra. 
Allergy & Asthma Network Mothers of Asthmatics (AANMA) President Nancy Sander presented the following testimony opposing over-the-counter status to the FDA advisory panel during a public hearing on May 11.

Dear FDA Advisory Committee, 
As president of Allergy & Asthma Network Mothers of Asthmatics, a nonprofit patient education and advocacy organization dedicated to eliminating death and suffering due to allergies and asthma, thank you for this opportunity to oppose OTC status for nonsedating antihistamines. 
Since 1985, AANMA has enjoyed excellent working relationships and received educational and unrestricted grants from numerous research-based pharmaceutical and device manufacturers. During 2001, the combined contributions from manufacturers of the medications in question total less than $50,000. 
Neither AANMA nor myself own stock or enjoy any financial interests in the companies represented in this issue. AANMA pays my salary. I have received and accepted no offers for expenses or opinions related to this event. I stand before you representing the best interests of more than 50 million consumers affected by allergies and asthma. 
AANMA opposes OTC status for nonsedating antihistamines. Asthma and allergies are serious, potentially life-threatening conditions which require medical diagnosis and strategic management. However, the average consumer does not possess the knowledge and skills necessary to safely self-diagnose and treat allergy symptoms without medical guidance. 
At best, their efforts are experimental. Stand in the cold and cough section of the grocery store and you'll witness confused consumers seeking medical advice from stocking clerks as to which medications they should take home to try. 
But when allergy symptoms drive the patient to the physician instead of the grocery or drug store for treatment, the physician examines the patient, takes a medical history, and if needed conducts diagnostic tests. Taking all information into consideration, a treatment strategy is developed for that person - one that permits the person to use as little medication as possible to obtain maximum results with minimal or no side effects. These medications may include but are not limited to nonsedating antihistamines. 
In fact, the patient may receive a prescription for one or more topical nasal sprays to reduce nasal inflammation and congestion. The physician may prescribe a simple recipe for a saline nasal wash, a medication-free and inexpensive means of removing offending allergens from the nasal passages. 
Furthermore, it is at this appointment that the physician should help the patient identify allergens to eliminate from the environment. Prevention, of course, is always the best and most cost-effective medicine. 
If only managing allergies were as simple as popping sugar-coated nonsedating antihistamines. But it is not. Chronic allergies take many forms, some subtle and others more obvious, but in all cases, consumer ignorance is not bliss. Consider the infants, toddlers, and children whose parents don't know it is allergies that cause their little ones to breathe through their mouths and not through their noses. Such seemingly trivial but chronic symptoms lead to facial malformations, increased dental carries, and the need for orthodontic work as they grow older. 
Chronic allergies can also lead to chronic asthma, a life-threatening condition that claims 15 precious lives each day. 
Who will inform parents, young adults, and the elderly of their treatment options? And how does even the most intelligent adult differentiate between a sinus infection and allergy, a cold and asthma, a cough due to allergy, asthma, sinusitis, or the flu? If we can't accurately self-diagnose, where do we begin to self-medicate safely and effectively? 
Consumers don't want to mask symptoms; they want to overcome and prevent them. A physician will not focus solely on the observed symptoms detected by the patient, but will try to identify underlying causes and in the process may eliminate repeated episodes through preventive measures - which may or may not include use of nonsedating antihistamines. 
As a patient advocate and a mom of four great kids, three with allergies and three with asthma, I am concerned that the people who I trust to understand these issues, health insurers, are seeking OTC status for chemically distinct, nonsedating antihistamines as if they were candy. Is this trust ill placed? 
The health insurers say nonsedating antihistamines are safe. And I agree. But only when used as prescribed by a physician. 
The health insurers say patients in other countries have used these medications safely for years. It is true that I can purchase nonsedating antihistamines over-the-counter in many countries. And in Third World countries, I can purchase asthma, heart, epilepsy, high blood pressure and many other medications OTC in pharmacies with earthen floors. But patients' access to care is nearly nonexistent for all but the wealthy. 
And isn't that really what this is all about? The cost of access to quality care? If these allergy medications become as readily available as candy as WellPoint's Chief Pharmaceutical Officer Robert Seidman desires, WellPoint won't have to pay for as many allergy visits. 
If the FDA says yes to OTC labeling for nonsedating antihistamines on the basis of arguments made by health insurers, it's simply one step closer to third world medicine standards. 

AANMA surveyed 1,200 members and nonmembers via e-mail. While the results are not scientific, we found overwhelming concerns best summed up by this statement: "Insurance companies are trying to find ways to save themselves money. If these drugs are put out over-the-counter, we the consumer will have to pay full price and not just a $5 or $10 deductible. What will be next? Self-help allergy testing kits and allergy shots you can give at home? Allergies are serious, especially when asthma comes into play. Drug interactions will become more prevalent. We're not doctors. It will get too confusing." 
Nearly 100 percent of respondents believe the move for OTC labeling of nonsedating antihistamines is purely financially motivated on the part of the insurers and has nothing to do with patient safety. One person wrote, "I'm starting to become depressed over insurance issues." 
Another wrote: "Insurance companies already exert too much control over decisions providers make and unfortunately many of those decisions are based on the financial needs of the company vs. the best course of treatment for the patient." 
Some respondents were uncertain about the impact OTC labeling would have on their livesthey simply did not have enough experience to make an informed judgment about the issue. One such person wrote: "When I was on OTC medicines before allergy testing, I became addicted to a nasal spray and couldn't breathe without it. It took a long time to get that cleared up." 
Where are the studies demonstrating strong consumer self-guided allergy diagnostic skills? Where is the research to support self-treatment and self-taught pharmaceutical dispensing and mixing? Where is the real evidence that real people would benefit from OTC status of nonsedating antihistamines? There is no evidence that patients can safely use OTC nonsedating antihistamines without physician interaction. Please do not support OTC status for nonsedating antihistamines until there is. 

Thank you,

Nancy Sander
President
Allergy & Asthma Network
Mothers of Asthmatics