
| Views Expressed Do Not Represent FDA |
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| Written by Dr. Michael Fleming |
| Tuesday, 25 August 2009 18:20 |
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Dr. Fleming is the former Consumer Representative on the Dental Products Panel of the Food and Drug Administration (FDA). He still receives many inquiries regarding his opinion on such issues as water fluoridation, dental filling materials, root canals and other important matters affecting the health and well being of Americans. It is important to understand any of Dr. Fleming’s statements about these issues are his personal opinions only but reflect many years of scientific study and involvement in a number of different public venues. They do not necessarily reflect views held by the FDA or any other regulatory body. Dr. Fleming’s position as the Consumer Representative does require him to interface on a regular basis with any and all interested stakeholders with respect to dental products and devices. These groups include health professionals, consumer and environmental advocacy groups, licensing boards, attorneys, news media outlets, industry, investment firms, trade and professional organizations, and federal, state and local government. An important part of Dr. Fleming’s responsibility is to engage the consumer public through various venues and offer help in understanding the complex process by which the FDA regulates products and devices. One of his chief obligations in this regard is to inform the public on methods that effectively communicate their concerns to the FDA. Advisory Panels do not regulate but only advise the FDA on matters related to the reasonable assurance of safety and effectiveness of drugs, biologics, and medical devices. Dr. Fleming’s specific role on the Products Panel is to bring the concerns of consumers to the FDA giving them a voice in a regulatory process that can directly impact their dental health care. Dr. Fleming also served as the Acting Consumer Representative on the Circulatory System Devices Panel that advises FDA on matters related to products and devices utilized within the heart and blood vessels. Dr. Fleming is a dental professional and, as such, cannot dispense medical advice with respect to devices reviewed before the panel or otherwise provide guidance that is the purview of physicians. Further information about Advisory Panels and their functions can be found at www.fda.gov. Dr. Fleming’s challenge to consumers of dental and medical services is to become a conscious consumer. That is, patients need to be proactive in their own health care choices and be vigilant and knowledgeable about the services and products offered in today’s competitive and rapidly changing environment. |