FDA
21st October 2013

AdComm Roll Call Special – Spotlight on: NDAC

The Nonprescription Drugs Advisory Committee (NDAC) has a
powerful voice in guiding FDA policy regarding self-care.

AdComm Roll Call Special – Spotlight on: NDAC

The Nonprescription Drugs Advisory Committee (NDAC) has a
powerful voice in guiding FDA policy regarding self-care and is tasked with weighing-in on the safety and effectiveness of over-the-counter (OTC) drugs. The topics of the meetings of NDAC vary, as this committee is responsible for the review of issues affecting currently marketed drugs and also the switch of products from prescription to OTC status.

So far this year, NDAC has met once, which was to review the proposed Rx-to-OTC switch of Nasacort AQ (triamcinolone acetonide) by French drugmaker, Sanofi. The issue of appropriate self-selection and use was discussed.

Nasacort AQ is indicated for hay fever and other upper respiratory allergies and was ultimately approved by FDA to be marketed OTC as the first intranasal corticosteroid for this indication. NDAC voted 10-6 in favor of this switch, with two members abstaining; clearly, FDA agreed with the majority in this case. However, several NDAC members expressed concern regarding how the product would be used in the OTC setting, without supervision by a healthcare provider. Their specific concerns included overdosing/overuse, using the drug to treat colds that were misinterpreted by the consumer as allergy symptoms, and consumers not knowing when to stop taking the product. Ultimately, the general consensus of the committee was that the safety risk associated with misdiagnosis is minimal because the common cold is self-limiting, and intranasal corticosteroids are generally safe to use.

NDAC consists of a core of 14 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of internal medicine, family practice, clinical toxicology, clinical pharmacology, pharmacy, dentistry, and related specialties. Currently, the Chair of NDAC is Dr. Richard Neill, whose expertise is family medicine. The current members of the committee can be found here and have a range of expertise, with several members who are pharmacists or pharmacology experts, internal medicine or family medicine experts, and even a statistician and mental health expert. The broad range of drugs encountered by this committee makes it unique, as the fields of expertise required may vary greatly from meeting to meeting.

 

Preparing for an NDAC meeting? Learn more about ISS’ Strategic Approach to Advisory Committee Prep!

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Subscribe to our blog to read our monthly roll call – who’s who on the drug advisory committees. Also stay tuned for next month’s spotlight AdComm – the Arthritis Advisory Committee!

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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