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Rx-to-OTC switch is the transfer of proven prescription drugs to non-prescription, OTC status. It is a scientifically rigorous and highly regulated process that allows consumers to have OTC access to a growing range of medicines.
In the US for example, the pharmaceutical industry continues to experience shifts from prescription medications to over-the-counter (OTC) drugs, with the FDA executing over a dozen transitions in the last 10 years alone. Rx-to-OTC opens new doors for both the consumer and the brand, with rising demand calling for change (the US OTC drug market is expected to grow until 2026). From the impacts of COVID-19 to the escalation in private labels and online sales, the push for this transition will persevere.
Consumers seek greater accessibility and convenience when purchasing medications, along with lower costs. People want to take responsibility for their own health, and this, combined with demographic changes and the increasing cost of professional healthcare, means that more must be done to develop and support-self-care. Thanks to Rx-to-OTC switches, consumers can conveniently buy and use a wider range of medicines and products without having to go to the doctor.
OTC products like non-prescription medicines, self-care medical devices and food supplements make an important contribution to health and well-being.
To determine which products are suitable for switching to OTC status, an assessment of whether the drug is amenable to self-medication must be made. The following criteria must be met:
- The product has an acceptable safety margin (e.g., benefits of OTC availability outweigh risks).
- The product has low misuse and abuse potential.
- A healthcare practitioner is not needed for the safe and effective use of the product.
- The product has appropriate labelling.
In addition, a sponsor must adequately establish that consumers can self-diagnose, self-select the medication, self-treat, and self-manage the condition for which the OTC drug is intended.
Seeking approval is a highly regulated process. The process that may be lengthy, requires strategic business operations models, but it can have positive returns for years to come.
This is therefore very important to evaluate strategically before starting, whether the product is suitable for a switch either in EU or US, and discuss actively with the authorities as needed.
Beyond regulatory duties, it is key to organise, anticipate and manage all the various activities and timing from strategy, subsequent communication with the authorities and market entry, without forgetting consumer studies such as: label comprehension, self-selection, and actual use studies.