Criteria Used by the FDA to Determine What Classes of Drugs are Appropriate Switch Candidates

Abstract

Although many of us have a strong belief that the availability of additional medications over-the-counter could make treatment more available and more economical, there has been no groundswell of support for them. Indeed, no consumer group or medical group has come out wholeheartedly for the concept of switches. Professional societies representing largely private medical practitioners have generally commented negatively on individual switches. Support from pharmacy seems confined to the advocacy of a third class of drugs. Indeed, the proprietary association has been something of a lonely advocate and even they had trouble finding a common ground on ibuprofen. FDA criteria for switching drugs from prescription to over-the-counter status are an overall evaluation of safety of the drug, including toxicity and other potentiality for harmful effect, abuse/misuse potential, benefit/risk assessment, as well as an assessment of whether the condition being treated is amenable to self-diagnosis and self-treatment and whether adequate labeling can be written for safe and effective self-treatment.