There has been a growing trend of Rx-to-OTC switch, whereby prescription drugs/prescription-only (Rx) medicines get converted to Over-the-Counter (OTC) products. The process has gained significant attention in the pharmaceutical industry, as it has led to a potential increase in patients’ access to effective treatments while at the same time reducing healthcare costs. This blog discusses the latest developments in Rx-to-OTC switch from a regional standpoint, the key considerations of pharmaceutical companies, and the importance of having a strategic Regulatory partnership.

Rx-to-OTC Developments in the US

The United States (US) Food and Drug Administration (USFDA) recently approved a nasal spray for the treatment of opioid overdose. The USFDA is also exclusively focusing on the development of an OTC oral contraceptive, which would be the first such product in the country. The primary benefit of the product would be increased access to birth control for women who may find it difficult to obtain a prescription from a healthcare provider. It could potentially reduce healthcare costs by eliminating the need for doctor visits.

Rx-to-OTC Developments in the EU

The European Union (EU)’s European Medicines Agency (EMA) has approved several applications since 2008. A prescription drug needs to undergo several stages to be considered an OTC product in the EU. Moreover, a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) indicates that the benefits of OTC use outweigh the risks.

Key Considerations for Rx-to-OTC Switch

The following are some of the key considerations that pharmaceutical companies must keep in mind while making the Rx-to-OTC switch:

  • Regulatory Compliance: Regulatory requirements are different for OTC and prescription drugs, and compliance with the standards of the USFDA or equivalent international Regulatory bodies is crucial. The drug must meet all the requirements, including labeling standards, safety guidelines, and efficacy parameters for OTC distribution.
  • Safety and Efficacy: The drug under consideration for the switch should have a well-demonstrated safety and efficacy profile. The likelihood of misuse or abuse, the potential for addiction, and the overall long-term safety profile are the key pointers to be kept in mind.
  • Consumer Understanding: OTC drugs must be safe and effective for self-administration by consumers. The labeling and instructions must be easily comprehensible, providing clear instructions on use, contraindications, and potential side effects.
  • Market Analysis: Evaluate the market dynamics, competition, and potential consumer demand for the OTC product. Research the market trends, assess the competitive landscape, and forecast potential sales to determine the financial viability of the switch.
  • Manufacturing and Supply Chain Capabilities: The switch might demand an increased production volume to meet the potential market demand. Assess whether your current manufacturing and supply chain capabilities can handle such an increase or whether expansion is necessary.
  • Pricing Strategy: Pricing strategies for OTC drugs often differ from prescription drugs. Thus, develop a pricing strategy that considers market dynamics, competitor pricing, and consumers’ willingness to pay.
  • Marketing and Advertising: Marketing strategies need to be revamped during the switch. Unlike prescription drugs, OTC products require consumer-focused marketing and advertising campaigns for driving consumer awareness and adoption.
  • Reimbursement and Insurance: Remember that insurance companies often do not cover OTC products, which in turn may affect consumer acceptance and usage of the product. Your switch strategy should therefore include plans to address this potential obstacle.
  • Pharmacovigilance: Post-marketing Surveillance (PMS) and ongoing safety monitoring continue to play an important role after the switch. You will need a robust pharmacovigilance system to monitor adverse effects and usage issues of the product in the larger consumer population.
  • Patient Education: As part of the switch, consider the need for patient education programs to ensure that consumers understand the correct usage, potential side effects, and when to seek professional medical advice.

The above considerations can be streamlined with one step – Regulatory consultation from a proven Regulatory partner. The consultation process involves Regulatory assistance, submission support, navigation through the Health Authority (HA) process post submissions, and post-switch responsibilities.


In conclusion, the Rx-to-OTC switch can increase patients’ access to effective treatments and reduce healthcare costs. Pharmaceutical companies must carefully consider Regulatory, educational, pricing, and competitive considerations when making Rx-to-OTC decisions. Having an expert Regulatory partner can enable you to address any hurdles that may come in the way of making a successful switch. At Freyr, our highly skilled Regulatory affairs consultants have complete knowledge of different HAs and can partner with you to help you accomplish your Regulatory and business objectives. Consult us to get assistance from our experts!


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