Attitudes and opinions towards regulatory aspects of non-prescription medicines

The first part of this investigation developed and described quantitative answers to questions that FDA has posed through the administration of an electronic survey questionnaire. The goal of this part was to qualitatively probe these issues further by conducting telephone interviews with key opinion leaders in the United States, Canada, the United Kingdom and Australia. This study aimed to extend the earlier effort and gain additional insight into issues described above and explored the opinions of thirty six key opinion leaders and stakeholders in the area of OTC medicines regulation from the United States, United Kingdom, Australia, and Canada. Results suggest that potential improvements to the US regulatory framework can include creation of an intermediate, pharmacist-controlled class of OTC medicines, delineation of data requirements in a guidance document to support a switch petition, regulation of nontraditional medicines (dietary supplements and nutraceuticals) also as per current OTC standards of premarket demonstration of safety and efficacy, and, the development of global OTC monographs. Responses showed support for regulatory agencies to unilaterally switch drug products and such decisions to be based only on the overall public health benefit considerations.