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Exclusive Q&A: Susan B. Levy Consulting’s Founder and Principal Discusses Rx-to-OTC Switch

Before she takes that podium at our 4th Rx-to-OTC Switch Summit, Susan B. Levy Consulting’s Founder and Principal, Susan Levy, sat down with ExL to discuss the OTC market and pre-launch preparation. Take a look here:

You’ve been involved in ExL Events’ Rx-to-OTC Summit since 2014 — what has changed since then and what brings you back?

Since 2014, we’ve seen additional switches in existing OTC categories, including Flonase, Nexium, Rhinocort, and Xyzal. Some of these switches have been more successful than others. We’ve also seen two Advisory Committee Meetings. Singulair failed to convince an Advisory Committee that its benefits as an OTC allergy product would outweigh certain risks, whereas the retinoid acne treatment Differin received a unanimous vote of approval. Nonetheless, Differin, which is a great product, has failed commercially. In each of these cases, there are always new lessons to learn to inform future Rx to OTC Switch programs.

Why are so few new drugs brought to OTC market?

Rx-to-OTC switch is a great way to launch a “new to the world” OTC brand. Nonetheless, there is a high-cost involved in this process, in addition to time and risk, and companies must convince themselves that the investment will be amply rewarded. Moreover, very few companies today have the expertise required to manage Rx-to-OTC switch programs, or access to switchable assets.

What are some ways pre-launch preparations lead to post-launch success?

That’s a great question, and it starts by selecting the right asset to switch at the right time in the drug’s life cycle. The ideal switch drug will address an unmet consumer need without any unwanted side effects. The switch team needs to ensure that their development program considers the potential to make compelling claims and that there is a strategy in place to gain exclusivity. Ideally, this process should start at least five years before the drug’s patent expires.

ExL is proud to partner with Susan B. Levy Consulting and has worked closely to build this year’s interactive conference workshop: How to Guide Your Organization Through an Rx-to-OTC Switch.
There are only two weeks left to take advantage of our Early Bird pricing! Register today to save $200! We’d be thrilled to have you join us in Philadelphia.

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