Asthma Drug Petition Opposes OTC Approach, NSURE Paradigm

The developing Rx-to-nonprescription switch paradigm should exclude asthma and anaphylaxis drugs, advocates argue in a citizen petition. They say making inhalers available OTC contradicts the current standard for care.

FDA’s consideration of switching Rx drugs to nonprescription under conditions of safe use “heightens the problem of poorly managed diseases” and should exclude rescue medicines for asthma and anaphylaxis, the Allergy and Asthma Network Mothers of Asthmatics argues in a citizen petition.

The nascent switch paradigm FDA is working to develop under its Nonprescription Safe Use Regulatory Expansion initiative – “is overbroad, runs contrary to well established national guidelines for asthma and anaphylaxis … focuses on symptom control with medication alone and, therefore, could increase the use of asthma and anaphylaxis medications,” and ultimately could increase mortality, Nancy Sander, president and founder of AANMA argues.

FDA is still in early stages of conceptualizing the NSURE initiative with stakeholders, but the program is intended to facilitate making Rx drugs available without a prescription under conditions of safe use, such as pharmacist involvement or educational kiosks. The initiative currently has no regulatory framework.

The petition, posted publicly June 19, is co-signed by the American Academy of Allergy, Asthma and Immunology, the American Association for Respiratory Care, the American College of Allergy, Asthma & Immunology, the American Latex Allergy Association and other health care groups.

At a 2012 public hearing to discuss NSURE, FDA Center for Drug Evaluation and Research Director Janet Woodcock said switching asthma inhalers and other prescription rescue medicines, like epinephrine auto-injectors for anaphylaxis, to restricted nonprescription would give people who previously had a prescription for the products easy access to the treatment during life-threatening events (Also see "Rescue Medicine Switch Concept Draws Criticism" - Pink Sheet, 2 Apr, 2012.).

Woodcock noted that sometimes inhalers and epinephrine auto-injectors malfunction, are empty or become lost and people who rely on them should be able to replace them quickly and easily.

However, the petitioners argue that by considering “allowing asthma inhalers to become a commonplace, OTC long-term solution, FDA is endorsing a practice of poor asthma control and, an increased risk of mortality.”

The petition says 20% of patients with severe persistent asthma “to their detriment” already rely exclusively on the quick-relief bronchodilators that FDA officials say could be switched OTC under NSURE.

Those patients “unknowingly neglect the fundamental underlying long-term root cause of their chronic and often progressive condition and may not notice a gradual deterioration of symptoms by refilling their short-acting, quick-relief bronchodilators without seeking medical advice,” according to the petition

“This leads to death by asphyxiation since over-use of short acting bronchodilator leads to receptors desensitization and patients no longer respond to asthma medications,” Sander says.

Making bronchodilators available OTC would reinforce these bad habits by making it easier to skip physician visits necessary for assessing patients’ condition and may lead consumers to select a treatment that masks symptoms rather than prevents or improves the underlying problem.

Currently available OTC in the U.S. is Nephron Pharmaceuticals Corp.’s Asthmanefrin asthma inhaler, a racepinephrine-containing spray liquid medication in aerosol form marketed as an “alternative” to Armstrong Pharmaceuticals Inc.’s Primatene Mist inhaler, which was pulled from the market at the end of 2011 under a ban of chlorofluorocarbon propellants (Also see "Nephron Launches Asthma Inhaler Into Wide Open OTC Market" - Pink Sheet, 27 Aug, 2012.).

Kiosks Versus Physicians

One option under NSURE to address concerns about consumer education and proper assessment and selection of drugs could be to use computer kiosks or other devices to walk consumers through the self-selection process of novel switches and deliver sufficient guidance about product use (Also see "Extra-Label Communication Could Foster Novel Switch NDAs – Industry Attorney" - Pink Sheet, 29 Oct, 2012.).

However, the petition says “procedures attempted by a kiosk will be less than thorough interpretation compared to a physician’s analysis.”

Physicians are best qualified to decide if a patient should use a short-term bronchodilator for fast relief or a long-term control product to prevent attacks, the petition says. Physicians also are needed to show consumers how to use a device and to evaluate whether a patient is complying with directions and whether a product is improving a person’s asthma and not masking the symptoms, the petition notes.

Teva Pharmaceutical Industries Ltd. voiced similar arguments about switching asthma treatments OTC in its comments to FDA about NSURE. Others voiced these concerns at the agency’s public meeting (Also see "Teva Opposes Switching Asthma Drugs, Oral Contraceptives" - Pink Sheet, 11 Jun, 2012.).

OTC Contradicts Standard Of Care

Making asthma and anaphylaxis treatments available nonprescription under NSURE also “is inconsistent and at odds with” professional treatment guidelines from NAEPP and the National Institute of Allergy and Infectious Disease, according to the petition.

NSURE addresses one of the four key components for asthma control under the NAEPP guidelines: providing appropriate medication. The initiative does not account for the other requirements: a physician’s assessment and monitoring, addressing environmental factors and emphasizing patient education, according to the petition.

Similarly, NSURE contradicts NIAID’s guidelines for identifying potentially life-threatening food allergies that might require an epinephrine auto-injector for treatment. The guidelines advise physicians to confirm a food allergy through a patient report of an adverse reaction, a blood test to measure antibodies indicating an allergic reaction, a skin prick test and a positive oral challenge test.

These steps are necessary to differentiate an allergy from a mere intolerance or dislike, the petition states. But by making these treatments available nonprescription, patients could side-step these assessments and inappropriately use an epinephrine auto-injector.

Actual Use Data Needed

The petition also argues that switching asthma and anaphylactic treatments OTC is inappropriate because no actual use studies exist to support the safety and efficacy of the products in an OTC environment.

Presumably, however, a sponsor trying to switch these products under NSURE would provide these data.

Without these studies, “OTC asthma and anaphylaxis medications lack critical clinical data necessary and thus fail to meet the FDA’s own rigorous legal and regulatory standard of care for safety and efficacy given the intended use described in the FDA paradigm,” the petition argues.

If these drugs are switched without these studies it would set a “damaging” precedent for public health policy, it adds.

NSURE A Work In Progress

The process for switching Rx drugs to nonprescription via NSURE is still being determined. The agency received 189 comments during the formal public comment period for NSURE – most of which were supportive, according to FDA.

The agency also has contracted the Brookings Institution’s Engelberg Center for Health Care Reform to analyze different options and aspects of the program. So far it has hosted two workshops with one more tentatively scheduled for the fall (Also see "FDA’s Broad Power Can Overcome NSURE Labeling Obstacles – Attorney" - Pink Sheet, 13 May, 2013.).

NSURE also could expand access to hormonal contraceptives, statins, triptans for migraines, sleep aids and new nicotine replacement therapies among other products by potentially allowing sponsors to use information technology or rely on pharmacists to help patients appropriately self-select the drugs.

Another rescue medicine under consideration for expanded access is naloxone, which can quickly revive patients who overdose on opioids (Also see "Naloxone Talk Sheds Light On Switch Research Future" - Pink Sheet, 7 Jan, 2013.).