FDA
18th July 2014

AdComm Roll Call – Spotlight on: Nonprescription Drugs Advisory Committee

NpDAC is responsible for review and evaluation of available data concerning the safety and effectiveness of over-the-counter (nonprescription) human drug products, or any other FDA-regulated product, for use in the treatment of a broad spectrum of human symptoms and diseases and advise the Commissioner either on the promulgation of monographs establishing conditions under which these drugs are generally recognized as safe and effective and not misbranded or on the approval of new drug applications for such drugs.

AdComm Roll Call – Spotlight on: Nonprescription Drugs Advisory Committee

FDA’s Nonprescription Drugs Advisory Committee (NpDAC) is one of the Agency’s busiest committees! With 3 meetings so far in 2014, NpDAC has stayed active!

NpDAC is responsible for review and evaluation of available data concerning the safety and effectiveness of over-the-counter (nonprescription) human drug products, or any other FDA-regulated product, for use in the treatment of a broad spectrum of human symptoms and diseases and advise the Commissioner either on the promulgation of monographs establishing conditions under which these drugs are generally recognized as safe and effective and not misbranded or on the approval of new drug applications for such drugs.

NpDAC serves as a forum for the exchange of views regarding the prescription and nonprescription status, including switches from one status to another, of these various drug products and combinations thereof. Additionally, NpDAC also conducts peer reviews of agency sponsored intramural and extramural scientific biomedical programs in support of FDA’s mission and regulatory responsibilities.

There were two NpDAC meetings in February and one meeting in May.

The first meeting of 2014 took place on February 25th. During this meeting, NpDAC met jointly with the Pulmonary-Allergy Drugs Advisory Committee (PADAC), and discussed data submitted by Armstrong Pharmaceuticals, Inc., in support of new drug application (NDA) 205920, for over-the-counter (OTC) marketing of epinephrine inhalation aerosol 125 microgram (mcg)/actuation (proposed trade name Primatene HFA), for temporary relief of mild symptoms of intermittent asthma for consumers 12 years of age and older. The epinephrine inhaler was developed as a replacement for Primatene Mist (epinephrine metered inhaler 200 mcg/actuation), an OTC product that was phased out in December 2011 because of the use of chlorofluorocarbons as the propellant. 

In this meeting, four discussion questions and three voting questions were posed to the committee. The panel voted 14, Yes and 10, No (with 1 abstention) that the efficacy data provided substantial evidence for the OTC use of epinephrine inhalation aerosol 125 mcg per inhalation in adults and children 12 years of age and older for the proposed indication. The panel voted 7, Yes and 17, No (with 1 abstention) that the safety of epinephrine inhalation aerosol 125 mcg per inhalation for OTC use in intermittent asthma was not adequately demonstrated. Lastly, the panel voted 6, Yes and 18, No (with 1 abstention) that the risk/benefit profile of epinephrine inhalation aerosol 125 mcg per inhalation was not supportive of OTC use for the temporary relief of mild symptoms of intermittent asthma, including wheezing, tightness of chest, and shortness of breath in adults and children 12 years of age and older.

The next day (February 26), another meeting was held that involved a discussion around over-the-counter (OTC) bronchodilators administered by hand-held rubber bulb nebulizers for the temporary relief of mild symptoms of intermittent asthma (shortness of breath, tightness of chest, and wheezing), and whether they should be removed from the monograph. Specific drugs discussed included epinephrine, epinephrine bitartrate, and racepinephrine hydrochloride (21 CFR 341.16).

During this meeting, the committee voted 15, Yes and 5, No (with 1 abstention) that epinephrine and racepinephrine delivered via a rubber bulb nebulizer be removed from the OTC Monograph (21 CFR 341: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use).

The last meeting in 2014 thus far was held on May 2nd. During this meeting NpDAC discussed data submitted by MSD Consumer Care, Inc., in support a new drug application (NDA) 204804 for over-the-counter (OTC) marketing of montelukast 10 milligram (mg) tablets (proposed trade name SINGULAIR Allergy). The proposed OTC use was “temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: Nasal congestion, runny nose, itchy, watery eyes, sneezing, itching of the nose.” The applicant proposed to label the product for OTC use in adults 18 years and older. Efficacy and safety data, as well as results of consumer studies, were discussed. 

The committee was given four discussion questions and two voting questions. For the first voting question, panelists voted 4, Yes and 11, No that the safety of OTC use of montelukast sodium for relief of allergy symptoms, considering potential off-label use, was not adequately demonstrated. Interestingly, the second voting question resulted in the exact same outcome regarding whether panelists felt the risk/benefit profile of montelukast sodium was supportive of OTC use in adults for the nasal indication “temporarily relieves symptoms due to hay fever or other upper respiratory allergies”?

There are currently no NpDAC meetings scheduled for the remainder of 2014, but we won’t be surprised if more pop up!

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ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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