Regulatory Focus™ > News Articles > Criteria for Evaluating the Safety of Rx-OTC Switch Candidates

Criteria for Evaluating the Safety of Rx-OTC Switch Candidates

Posted 01 September 2009 | By

As the baby boomer population ages, demands for self-medication options will grow. There is a wide spectrum of drivers for this growth: cost shifting from governments and insurance carriers to consumers, increased consumer access to medical information and interest in managing their health, and greater industry awareness of lifecycle management for "old" drugs that are past patent protection but still play a therapeutic role. Underlying these factors is the recognition that a switch from prescription (Rx) to over-thecounter (OTC) status benefits public health by increasing consumer access to, and utilization of, effective pharmacotherapies.

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