FDA and the Challenge of Alternative Medicine: Realistic Assessments and Regulatory Flexibility

Abstract

Alternative medicine has already established a role for itself in the health care of many Americans. FDA, however, has been slow to develop a meaningful and coherent regulatory response to this growing phenomenon. Reluctant to change its mind-set, FDA acts under the mistaken belief that the current regulatory scheme can accommodate any alternative medicine that will be useful to the public. Because of their conceptual and philosophical differences from conventional medicine, however, many alternative therapies simply cannot meet the demands of the current regulatory system. This reality does not imply that such medicines are not valuable. While it is true that many practices that are labelled alternative are nothing more than health fraud and often dangerous, there are also many medicines with great potential to improve how Americans think about and use medicine. A coherent policy toward alternative medicine and a more flexible regulatory scheme are required of FDA if Americans are to be given the freedom to choose different forms of health care safely and wisely.