FDA
17th January 2014

AdComm Roll Call – Spotlight on: Pulmonary-Allergy Drugs Advisory Committee

The Pulmonary-Allergy Drugs Advisory Committee (PADAC) has an influential voice in guiding FDA policy regarding the safety and effectiveness of marketed and investigational human drug products for use in the treatment of pulmonary disease and diseases with allergic and/or immunologic mechanisms. This committee consists of a core of 13 voting members including the Chair. Currently, 12 of those seats are full and there is only one vacancy.

AdComm Roll Call – Spotlight on: Pulmonary-Allergy Drugs Advisory Committee

The Pulmonary-Allergy Drugs Advisory Committee (PADAC) has an influential voice in guiding FDA policy regarding the safety and effectiveness of marketed and investigational human drug products for use in the treatment of pulmonary disease and diseases with allergic and/or immunologic mechanisms. This committee consists of a core of 13 voting members including the Chair. Currently, 12 of those seats are full and there is only one vacancy.

PADAC met four times in 2013 and currently has one meeting scheduled for February 25th, 2014. Interestingly, in 2013, the committee met 3 of the 4 times to discuss New Drug Applications for COPD treatments. At all three meetings the committee was generally positive and voted in majority for the approval of the new drugs. The fourth meeting was also for a NDA, for Bronchitol – indicated for the management of cystic fibrosis. This meeting was largely negative as the committee was faced with a drug intended for children ages 6 years and older and found little benefit in this young population.

The meeting scheduled for this year will likely be of great interest as the NDA being discussed is for the over-the-counter (OTC) marketing of an epinephrine inhalation aerosol (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, an OTC product that was phased out in December 2011 because of the use of chlorofluorocarbons as the propellant. This meeting will be a joint affair between PDAC and the Nonprescription Drugs Advisory Committee (NDAC).

There will likely be debate around the safety of this product as epinephrine inhalers are not part of current clinical treatment guidelines because epinephrine is no longer considered a safe medication for treating asthma, according to several medical organizations. Those organizations include the American College of Asthma, Allergy, and Immunology; the American Association of Respiratory Care; the American Thoracic Society; and the National Association for the Medical Direction of Respiratory Care.

The FDA clearly has an interest in the class of products as they have scheduled a meeting immediately following the discussion of Primatene on the 26th of February, with the Nonprescription Drugs Advisory Committee alone, to discussed whether OTC bronchodilators for the temporary relief of mild symptoms of intermittent asthma (shortness of breath, tightness of chest, and wheezing) should be removed from the monograph. Specific drugs to be discussed include epinephrine, epinephrine bitartrate, and racepinephrine hydrochloride.

These will certainly be meetings to monitor closely as the results of the meeting on the 25th may provide indication as to how the meeting on the 26th will turn out.

 

What happens when the committee votes negatively? Find out by downloading ISS’ negative outcome analysis where we watch for FDA’s decisions following negative adcomms.

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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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