Conference Schedule
Switches are often considered in a company when a patent is near its expiration date because the price drastically decreases. Another crucial consideration is whether the drug’s safety profile is clean and safe for consumers to use.
• Determine when the patent on a drug expires and whether it will benefit the company to make the switch
• Assess consumer needs to determine if there is a market need for it
• Evaluate scale and volume and how the business model will change and determine if the company is prepared to handle these changes
Rx to OTC Switch is a high-risk/high-reward proposition. In order to maximize the potential of an Rx to OTC switch, it is critical to ensure that the proposed switch is addressing an unmet consumer need.
• Making financial sense – materiality and risk tolerance
• Internal and external considerations that impact financial viability of your program
• Identifying and delivering on unmet consumer need
• Navigating uncertainty with discover-driven planning
• Building and maintaining a dynamic forecast model
A submission process can be lengthy and expensive. Save time and money by creating an organized plan and understanding of what is required for approval.
• Hold preliminary meetings with the FDA before submission to determine the potential for a switch
• Conduct consumer behavior studies that demonstrate the medication can be taken without HCP supervision
• Create arguments that show the benefits outweigh the risks
• Provide sufficient data demonstrating the safety profile of the drug
Part 1:
It is important to determine how to address labeling and packaging needs while staying in compliance. Proper consideration for key safety features is a must.
• Overview of Rx to OTC Switch and central role of packaging: Articulating differences between Rx & OTC packaging.
• Understand key packaging considerations in Rx to OTC Switch: Packaging requirements based on regulations, patient use, convenience, etc.
• Discuss labelling adaptations for OTC packaging: FDA regulations on labelling, Human Factors, etc.
• Explore supply chain & scale up challenges: Manufacturing considerations.
• Discuss the importance of design considerations: Key element of Rx-to-OTC switch packaging rests on design
Part 2:
Using the practical neuroscience behind consumers sequence of cognition at shelf, part 2 will reveal how to design a Rx-to-OTC brand’s most important asset—trade dress. A strong and strategic brand positioning is key to outsmart competitors and win consumers.
• Understand how to select proprietary color combinations to build a highly intuitive, ownable, and memorable shelf strategy
• Learn how to develop shapes and symbols built into your logo and brand-mark
• Create verbal branding that is monograph-informed and competitive to reinforce brand superiority and recall in the mind of the consumer
• Understand trademark and IP and how to protect these visual and verbal assets
The process of planning, developing, and validating a new OTC product opportunity via the regulatory Rx to OTC switch pathway.
  • Discuss the different levels of financial and team support switches require with various levels of commercial, regulatory, clinical, and operational involvement
  • Develop and manage a team that’s right for your switch
  • Lessons learned from an active Switch by a non-profit organization (naloxone)

Leveraging the marketing power of Rx to OTC Switch through:

• Identifying key market research insights on category indications, consumer use, and differentiative claims driving trial
• Building positioning and branding around product essence and executing across marketing vehicles
• Understanding the role of health care professionals in influencing purchase decisions
• Addressing consumer barriers to advance availability, access, and adoption

In order to have a drug approved for OTC use, sufficient data has to be submitted to the FDA demonstrating that consumers will understand how to use the product safely. This data is collected though consumer behavior studies.

  • Defining success
  • Standard studies
  • Nothing is standard – our responsibility as sponsors
  • Successful label, program, and study design
  • Discovery Driven Planning in Behavior Program
Providing access to more OTC medications empowers consumers to take control of their health. With that accomplished, they can achieve better health outcomes while avoiding market cost increases.
• Discuss the benefits of consumers taking more control of their health and allowing them to feel empowered to make their own health decisions
• Prevent consumers from neglecting their own treatment due to lack of access to HCPs
• Drive affordability without relying on insurance and copays
Consumers can take advantage of utilizing pharmacists, as they are extremely knowledgeable about medications and are easily accessible. How should drug companies bear this in mind when planning upcoming switches?
• Educate consumers on medications
• Transfer responsibility from HCPs and allow pharmacists to play an active role in consumer health
• Bridge the gap for consumers who may not have access to healthcare

Artificial intelligence (AI) is an emerging field. It allows a machine to make decision based on data, environment or inputs. AI can be of particular use in efficient process validations. It can learn complex interdependencies among numerous inputs and use this learning in validating the outcome of a process with very high efficiency and precision. Process validation is critical for both Rx and OTC drugs.


• Dive into the benefits of utilizing AI
• Discuss the examples of process validation using AI
Marketing to doctors and other HCPs can be different in some ways from marketing to consumers. HCPs are more concerned with scientific data behind a product, whereas consumers are interested in how a product can help them.
• Define the role of HCP within the switch
• Discuss how to build an effective strategy B2B vs B2C
• Ensure consistency of messages between HCP and consumer
• Discuss marketing opportunities and challenges
The evolving consumer behavior and new era of switches will benefit from a new focus on digital engagement. This session covers the value of incorporating technology for Rx to OTC switches.
• Promote safety usage
• Embrace wearables and digital technology
• Utilize AI
• Take advantage of future packaging
A switch is a complex process and may seem like daunting task to smaller companies that lack the resources. How can smaller companies align their strategy to become a player in this field?
• Obtain an understanding of what is required
• Fully understand your drug proposition and unmet consumer needs
• Stay focused and ensure your plan aligns with FDA requirements to give you commercial success
• Rely in bulk and less advertisement until you build a larger base
• Partner with someone who has a large space in OTC
Innovative strategies and leadership practices spell success or failure for switches. By reviewing what has worked in the past, you can improve the likelihood of securing approval and commercial success moving forward.
• Discuss recent legislative changes
• Outline the FDA’s authority, goals, and objectives
• Create a guide and pathway for future switches

Rx companies with switchable prescription assets can achieve long-term life cycle value by pursuing an Rx to OTC switch. Driving success with OTC drugs requires different capabilities than driving success with Rx drugs, however, and therefore a strategic assessment of whether to build, borrow, or buy those capabilities is a critical part of the Rx to OTC switch process.

• Discuss how Rx and OTC capabilities differ
• Analyze the options that should be considered to ensure that OTC capabilities are established for the switch
• Consider partner selection if you choose to partner with an OTC company

Digital platforms are a necessary tool in consumer engagement. They can help pharmacies understand consumer needs and behavior patterns. Digital platforms can also be a great tool to collect data from consumers.
• Share the role of digital platforms for consumer engagement at a leading health-system outpatient pharmacy
• Explain lessons learned in creating a digital presence that is consumer-centric and allows consumers virtual engagement with care providers
• Propose future directions in digital platforms for outpatient pharmacy