OTC Asthma Treatment Stirs ACAAI Controversy

November 17, 2012 — A proposal from FDA for an expansive approach to OTC drugs spurred the American College of Allergy, Asthma, and Immunology (ACAAI) to hold a symposium on the subject and to hotly debate the topic throughout the course of its annual meeting this week.

As an indication of how important the subject is to ACAAI, three of its past presidents — Bob Lanier, Michael Blaiss, and William Dolan — presented at the symposium. Michael Foggs chaired the session.

Two potential new OTC options were the focus: nasal steroid sprays for allergic rhinitis and asthma inhalers. Though it’s clear that the allergists would prefer to have people see an an allergist for allergic rhinitis, all three speakers acknowledged that more switches from prescription to non-prescription status may be inevitable. “I get allergic rhinitis and appreciate being able to get a good treatment without a prescription,” said Dolan after the session.

But the possibility of OTC asthma inhalers seems to be really troubling, because asthma can be life-threatening. Dolan was most provocative in his presentation about asthma. “How many patients must die?” he asked in his concluding remarks.

The proposal from FDA was the subject of a public hearing in March. For a range of conditions like asthma, high cholesterol, and high blood pressure, FDA is exploring the possibility that some treatments might be available without a prescription under a pharmacist’s supervision. These conditions are sometimes referred to as “conditions for safe use” (CSU) or “behind the counter” (BTC).

The hearing brought out some support for the idea, tempered by a great deal of caution about the danger of reducing the medical attention that people receive for serious chronic conditions.

Access slides from the ACAAI symposium here: Foggs, Lanier, Blaiss, Dolan.

Read about the March hearing here, along with differing points of view here and here.