The US Food and Drug Administration (FDA) has had a contentious relationship with over-the-counter products (OTC) in recent years. While a considerable amount of attention has been paid to a lengthy episode involving the birth control drug levonorgestrel and what age groups are cleared to access it, less attention has been spent on a product that is arguably even more important: asthma inhalers.

Background

In March 2012, FDA announced it would start to unveil a new "paradigm" meant to permit more medications to "switch" from prescription status to OTC status. The intent, regulators explained, was to help accommodate patients who might otherwise be disinclined to treat a disease or condition due to the prohibitive costs or waiting times associated with seeing a doctor or a physician.

This could involve creating an easier pathway to get drugs approved as OTC products or might, regulators postulated, involve a half-way measure such as requiring the help of a pharmacist to dispense some products.

"For example, before getting a medication, you might have to talk with a pharmacist, or need to have a diagnostic test," wrote FDA in a statement. "In other cases, you might have to visit a physician to obtain the original prescription, but not to get refills."

The agency also postulated that it might permit a partial prescription-to-OTC switch, leaving some indications as prescription-only while allowing other populations or indications to obtain the drug OTC. The first approval based on that understanding occurred in January 2013 with the partial switch of Oxytrol, a bladder control drug.

Further Developments

FDA's thinking in this area has received added scrutiny by legislators in recent months due to an environmental regulation that upended the availability of an OTC epinephrine-based inhaler. In that case, the inhalers were taken off the market due to their use of chlorofluorocarbons (CFCs)-a type of propellant used to discharge the epinephrine from the device. CFCs have technically been banned since the US signed on to the 1987 Montreal Protocol, an international agreement aimed at preserving the ozone layer, but the ban has been delayed repeatedly over the years.

On 1 January 2012, however, those delays ended, with FDA pulling the epinephrine inhalers off the market. Proponents of the inhalers said this was a disservice to patients, who had lost access to the OTC inhalers and would now need to see a physician to obtain a prescription inhaler, dramatically raising the costs of treatment.

Citizen Petition: No OTC for Asthma Products

But a new Citizen Petition submitted to FDA by an asthma-based patient group argues that asthma patients should have to see a doctor, and that FDA's new OTC paradigm is "overboard, runs contrary to well-established national guidelines for asthma and anaphylaxis, had unintended public policy consequences and lacks demonstrates safety and efficacy data" to permit use in an OTC setting.

The group, Allergy & Asthma Network Mothers of Asthmatics (AANMA), has long been vigorously opposed to the measure. In an interview posted on its website between the group and Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), AANMA argues that average patients will not know how to self-medicate, and that asthma treatment involves more than just an inhaler.

"I think one of the biggest problems with FDA's paradigm is it characterizes albuterol and bronchodilators in general as a 'rescue' therapy as if it was a life jacket," said Nancy Snyder, AANMA president, in the interview. "Look at the package insert. It clearly states that albuterol should be used at the first sign of symptoms and before exercise. It will not re-inflate or reopen fluid-filled and mucous-plugged airways. It never claims it will rescue a patient although this misleading slang terminology has made it into advertising."

In the same interview, Woodcock noted the agency's concerns that some patients either don't have access or cannot afford to access the services of a physician, and that certain tools and paradigms may facilitate a basic level of treatment not otherwise available.

Three Points

AANMA's Citizen Petition represents a more formal effort by the organization to get FDA on the record as either approving of disapproving of the effort to allow asthma inhalers to be made available OTC. The petition argues three principal points:

1. FDA's paradigm (as it relates specifically to asthma products) are inconsistent with guidelines put forth by the National Institutes of Health and various medical groups, all of whom say that routine care is a necessary and beneficial component of an asthma treatment regimen. Patients, they add, do not have all the "necessary decision-making tools and independent self-assessment, monitoring, prevention and emergency management skills" to treat their condition.
2. No "Actual use" studies exist to support the use of asthma medication in an OTC setting. A similar argument was advanced against the OTC use of Teva Women's Health's Plan-B One Step (levonorgestrel).
3. Improper use of bronchodilators has been known to lead to treatment resistance of the condition (desensitization of the receptors), leading to a lack of response sometimes resulting in death. "FDA is endorsing a practice of poor asthma control and an increased risk of mortality," AANMA wrote.

Similar arguments are also advanced in the petition against OTC treatments for analphylaxis, a potentially deadly allergic reaction (often to food) that can cause an asthma attack. AANMA argued the condition is neither amenable to self-diagnosis nor suitable for OTC status since treatments are epinephrine based and the drug is associated with various toxicities.

Accordingly, the group said it "respectfully requests an exemption for asthma and anaphylaxis medications from the list of over the counter (OTC) medications in the proposed new FDA Paradigm."

FDA now has 180 days within which to respond to the Petition.

AANMA Citizen Petition