11.01.02
The U.S. Senate recently confirmed the appointment of Mark McClellan, M.D., Ph.D., as commissioner of FDA. The nomination of Dr. McClellan, a 39-year-old medical doctor and economist, moved to the full Senate after he was approved by the Health, Education, Labor and Pensions Committee. Prior to the confirmation, The Consumer Healthcare Products Association (CHPA) submitted a list of questions concerning the self-care industry to U.S. Senator Tim Hutchinson (R-AK.). Senator Hutchinson agreed to pose those questions to Dr. McClellan as part of the confirmation process. Among the questions posed was one regarding dietary supplements. Senator Hutchinson asked Dr. McClellan, “Based on recent actions by FDA relating to dietary supplements, such as the development of a more rigorous adverse event surveillance system and several enforcement actions relating to safety and claims, do you agree that the Dietary Supplement Health and Education Act of 1994 provides FDA with adequate legal authority to regulate dietary supplement products?” In response to this question, Dr. McClellan stated, “While my examination of issues relating to dietary supplements has allowed me to appreciate the challenges the agency faces under the Dietary Supplement Health and Education Act of 1994, at this time I do not have specific statutory changes to recommend. As commissioner, I will work with the department and with Congress to implement the act in accordance with congressional intent.” An official swearing-in ceremony is the only step of the process that remains before Dr. McClellan can take over the long-vacant seat in the commissioner’s office. No date was set as we went to press, but confirmation was expected to happen after the November elections.