Rx to OTC Switch (Part 1 of 2): Planning for Regulatory Success

Rx-to-OTC switch is a complex process involving numerous parallel workstreams; the goal of the process is regulatory approval of a commercially viable OTC product that will benefit public health

In this first of two webinars, the presenters will focus on best practices for achieving regulatory approval of an Rx-to-OTC switch. The presenters will flag the critical points in the regulatory process where commercial teams need to become involved, although the best practices for achieving commercial success will be covered in further detail in the second webinar of the series.

Successful Rx-to-OTC switches have been defined by:

• Thoughtful selection of switch candidates through regulatory and commercial feasibility assessments
• Early development of FDA strategy, taking into consideration development of a sound Drug Facts Label and other consumer information materials, as well as well-designed consumer studies. These studies include label comprehension, self-selection and, if needed, behavioral (actual use) data to demonstrate the drug can be used safely and effectively in the nonprescription setting
• Identifying and addressing concerns of FDA and other key stakeholders with science-based, data-driven responses
• Building a compelling benefit/risk case for the switch
• Strong leadership and project management linking regulatory, clinical, medical and commercial strategies and workstreams

Speakers

Christine Sweeney, Ph.D., MPH, Director, Issues Management, PinneyAssociates

Christine has supported a range of Rx and OTC clients in therapeutic areas including, pain management, smoking cessation, weight loss, cholesterol lowering, allergic rhinitis, women’s reproductive health and men’s health. She assists clients in the development of labeling and the design of consumer studies (label comprehension, self-selection, actual use), as well as the drafting of regulatory submissions in support of Rx-to-OTC switch programs. For nearly two decades, Christine has applied her expertise in behavioral and public health to support clients’ efforts to gain approval and expand the market for pharmaceutical and consumer healthcare products with a focus on building the benefit/risk case for a switch and managing the issues raised by switch.

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George Quesnelle, Senior Strategic Advisor, OTC Commercialization and Optimization, PinneyAssociates

George Quesnelle has nearly 30 years of Rx-to-OTC switch experience, with commercial responsibility for some of the most successful switches in the industry, including Nicorette and NicoDerm CQ.  He advises clients on the commercialization process for the switch, including OTC switch candidate identification, forecasting OTC switch volume, helping to develop or evaluate marketing plans as well as consumer and trade promotions and sales strategies.  George helps clients evaluate manufacturing and distribution scenarios to minimize risk and maximize launch success. From 2004 to 2008, George was President of GSK Consumer Healthcare North America. In 2014, the Consumer Healthcare Products Association awarded him the Ivan D. Combe Lifetime Achievement Award for his contributions to the industry, especially his pioneering work in OTC switch and directly improving self-care for consumers in the US.

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