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Lifecycle Management Through the Rx-to-OTC Switch
Preface
Welcome to the inaugural edition of RAPS’ Lifecycle Management Through the Rx-to-OTC Switch: US
Considerations and Perspectives to Advance Self-Care. This book is a culmination of my involvement in
switches, learning from the few available guidance documents, and most significantly, interacting with
highly experienced regulatory professionals. The increased relevance of over-the-counter (OTC) or
self-care products to consumers and patients alike was also a driver in developing this practical reference
manual for the regulatory community.
The availability of OTC medicine, relative to prescription alternatives, provides significant value to
the US healthcare system—$102 billion in annual savings—or, on average, every dollar spent on OTC
medicine results in $6-7 in value for the US healthcare system as a whole.1 In addition, the US OTC
market is expected to grow from its $25 billion in annual sales in 2013 to approximately $42 billion in
2024, a sales increase of 68%.2 Part of that growth will be the result of Rx-to-OTC switches creating new
commercial opportunities for pharmaceutical manufacturers. OTC product development also has been on
the rise since the enactment of the 21st Century Cures Act3 in 2016 and the Cares Act in 2020.4
Through a series of case studies, a group of highly respected regulatory experts illustrates the basic
requirements for implementing a switch to increase availability of, access to, and adoption of OTC medi-
cations, thus enabling more consumers to avail themselves of proven therapies.
This is a new book topic for RAPS. It is intended for newcomers and seasoned professionals,
ranging from those working in product development and marketing, to those in regulatory affairs.
Lifecycle Management Through the Rx-to-OTC Switch is a valuable resource for any regulatory professional
interested in learning about or pursuing a switch.
Robert Falcone, PhD, FRAPS (Lead Editor)
Senior Manager, Regulatory Affairs
Prestige Consumer Healthcare
References
1. The Value of OTC Medicine to the United States. January 2012. Consumer Healthcare Products Association (CHPA) White
Paper. CHPA website. https://www.chpa.org/sites/default/files/media/docs/2020-10/The-Value-OTC-Medicine-to-the-
United-States-01012012.pdf. Accessed 22 July 2021.
2. Value of the OTC Medicines Market in the US 2013-2024 by Segment. July 2021. Statista Research Department. Statista
website. https://www.statista.com/statistics/255103/value-of-the-otc-market-in-the-us-by-segment/. Accessed 22 July 2021.
3. 21st Century Cures Act. Current as of January 2020. FDA website. https://www.fda.gov/regulatory-information/selected-
amendments-fdc-act/21st-century-cures-act. Accessed 22 July 2021.
4. An Exciting New Chapter in OTC Drug History: OTC Monograph Reform in the CARES Act. Current as of August 2020.
FDA website. https://www.fda.gov/news-events/fda-voices/exciting-new-chapter-otc-drug-history-otc-monograph-reform-
cares-act. Accessed 22 July 2021.
Lifecycle Management Through the Rx-to-OTC Switch
Preface
Welcome to the inaugural edition of RAPS’ Lifecycle Management Through the Rx-to-OTC Switch: US
Considerations and Perspectives to Advance Self-Care. This book is a culmination of my involvement in
switches, learning from the few available guidance documents, and most significantly, interacting with
highly experienced regulatory professionals. The increased relevance of over-the-counter (OTC) or
self-care products to consumers and patients alike was also a driver in developing this practical reference
manual for the regulatory community.
The availability of OTC medicine, relative to prescription alternatives, provides significant value to
the US healthcare system—$102 billion in annual savings—or, on average, every dollar spent on OTC
medicine results in $6-7 in value for the US healthcare system as a whole.1 In addition, the US OTC
market is expected to grow from its $25 billion in annual sales in 2013 to approximately $42 billion in
2024, a sales increase of 68%.2 Part of that growth will be the result of Rx-to-OTC switches creating new
commercial opportunities for pharmaceutical manufacturers. OTC product development also has been on
the rise since the enactment of the 21st Century Cures Act3 in 2016 and the Cares Act in 2020.4
Through a series of case studies, a group of highly respected regulatory experts illustrates the basic
requirements for implementing a switch to increase availability of, access to, and adoption of OTC medi-
cations, thus enabling more consumers to avail themselves of proven therapies.
This is a new book topic for RAPS. It is intended for newcomers and seasoned professionals,
ranging from those working in product development and marketing, to those in regulatory affairs.
Lifecycle Management Through the Rx-to-OTC Switch is a valuable resource for any regulatory professional
interested in learning about or pursuing a switch.
Robert Falcone, PhD, FRAPS (Lead Editor)
Senior Manager, Regulatory Affairs
Prestige Consumer Healthcare
References
1. The Value of OTC Medicine to the United States. January 2012. Consumer Healthcare Products Association (CHPA) White
Paper. CHPA website. https://www.chpa.org/sites/default/files/media/docs/2020-10/The-Value-OTC-Medicine-to-the-
United-States-01012012.pdf. Accessed 22 July 2021.
2. Value of the OTC Medicines Market in the US 2013-2024 by Segment. July 2021. Statista Research Department. Statista
website. https://www.statista.com/statistics/255103/value-of-the-otc-market-in-the-us-by-segment/. Accessed 22 July 2021.
3. 21st Century Cures Act. Current as of January 2020. FDA website. https://www.fda.gov/regulatory-information/selected-
amendments-fdc-act/21st-century-cures-act. Accessed 22 July 2021.
4. An Exciting New Chapter in OTC Drug History: OTC Monograph Reform in the CARES Act. Current as of August 2020.
FDA website. https://www.fda.gov/news-events/fda-voices/exciting-new-chapter-otc-drug-history-otc-monograph-reform-
cares-act. Accessed 22 July 2021.