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Executive Summary

A seven-year exclusive marketing period for medical foods approved through a new FDA review process is being urged by an advocacy group called the Foundation for Innovation in Medicine. Seeking a new class of FDA-regulated product between drugs and foods, the advocacy group is taking the first steps to develop a public awareness campaign for its cause. The initial outline of its proposed regulatory scheme is contained in a Dec. 2 "white paper." As part of the plan to establish a new regulated category, the white paper calls for consideration of a "Nutraceutical Research and Development Act" by Congress. "Using the Orphan Drug Act as a model," legislation could grant seven years exclusivity "for health claims based on approved proprietary research." The foundation defines nutraceuticals as "any substance that may be considered a food or part of a food and provides medical or health benefits, including the prevention and treatment of disease." Such legislation also should provide for the "creation of appropriate channels for the review, approval and regulation of new products and claims," the white paper states. Specifically, a "Nutraceutical Commission (NUCOMM)" could be established "within the FDA under a Nutraceutical Commissioner, who reports to the Commissioner of the FDA." The Commission would "administer the review and approval requirements of nutraceuticals as well as to work across government lines with the FDA, FTC, USDA and their respective functions." The foundation believes that "the current U.S. economic and regulatory system is a powerful deterrent to the discovery, development and availability of innovations" in the "vast category" of nutraceuticals. Because the U.S. regulatory system has no "guaranteed exclusive rights as the fundamental incentive for companies to invest" in nutraceutical research and development, the foundation argues, the U.S. has fallen behind Europe and Japan. The head of the foundation Stephen DeFelice, MD, maintains that Sanofi, Sigma Tau, and Glaxo are all working on nutraceutical research. He contends that Japanese firms hold over 50% of the medical patents on plants worldwide. The "white paper" was developed with the help of the foundation's Nutraceutical Advisory Group, which includes Louis Lasagna, MD, dean of the Sackler School of Graduate Biomedical Science at Tufts University, and two former senior FDA attorneys, Stephen McNamara and Thomas Scarlett, both of whom are now with the law firm of Hyman, Phelps and McNamara. Under the proposed regulatory scheme, sponsors would submit a New Nutraceutical Application, or NNA, which initially would be reviewed by NUCOMM. If the commission deemed the application reviewable, it would be sent "for review by appropriate outside experts drawn from a list of authorities in various specialities." The paper adds that "because regimented guidelines and subcategories are difficult to formulate in the area of nutrition, submissions will be reviewed on a case-by-case basis." The agency's treatment of medical foods and dietary supplements has been the focus of two FDA task forces established by FDA Commissioner Kessler in April. The activity was precipitated by the agency's ban on the marketing of the amino acid L-tryptophan ("The Pink Sheet" July 22, T&G-2). Reports from those task forces in the form of "option papers" are due by the end of the year.At a Dec. 5 meeting of FDA's Orphan Products Board, John Kelsey, MD, the executive secretary of the two FDA boards, said the question of whether FDA currently has sufficient statutory authority to regulate dietary supplements will be addressed in those papers. An example of the controversies faced by the agency in this area is L-carnitine, which currently is sold OTC as a dietary supplement. Sigma-Tau Pharmaceuticals has orphan exclusivity for its carnitine supplement Carnitor as a drug. National Organization of Rare Disorders Executive Director Abbey Myers reported at the meeting that doctors often recommend patients with carnitine deficiency buy a less expensive OTC supplement because Carnitor often is not reimbursable by third party payers.

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