Medical Foods: Clinical Research and Product Development Opportunities

Why Should You Attend:

As a distinct, FDA-regulated category, medical foods represent a substantial nutritional market opportunity. However, they remain poorly understood by patients, pharmacists and physicians. The development and sales of medical foods involve fewer regulatory requirements than those needed for drug development and approval.

Unlike foods for special dietary purposes (such as a food allergy or difficulty in swallowing, or nutrients intended to meet ordinary nutritional requirements) the FDA views medical foods as an integral component of the patient's clinical management.

Medical foods are specifically formulated and processed for a patient who is seriously ill or requires use of the product as a major component of a disease or condition’s “specific dietary management.” Medical foods must be labelled for the “dietary management of a specific disease” rather than for a treatment of a disease or medical condition. A distinctive nutritional requirement based on recognized scientific principles must be established. Also, a patient must be receiving active or ongoing medical supervision and must be provided instructions on the use of the medical food.

FDA (1996) advised that the term "specific dietary management” means that medical foods can be an integral part of the clinical treatment of patients to help "ameliorate clinical manifestations of the disease," "favorably influence the disease process," and "positively influence morbidity and mortality (patient outcomes).” Thus, any pharmaceutical/nutritional company that is interested in developing products for medical conditions should be aware of the product opportunities for medical foods.

Areas Covered in the Webinar:

• Definition of Medical Food
• History of Medical Foods
• Regulation of Medical Food
• Categories of Medical Food
• Differences Between Medical Foods, Drugs, and Dietary Supplements
• Clinical Research of Medical Foods
• Examples of Medical Foods
• Product Development Opportunities

Who Will Benefit:

• Director of Clinical Research
• Director of Regulatory Affairs
• Director of Sales and Marketing
• Clinical Research Manager
• Regulatory Affairs Manager
• Formulation Manager
• Marketing Analyst/Manager

Free Materials:

• Reference documents
• Tables
• Articles

Alan S Ryan
President, Clinical Research Consulting

Alan S. Ryan, PhD is a recognized scientist with over 150 articles and 40 years of experience in preclinical and clinical research, including protocol development, report writing, publications, and FDA submissions. Dr. Ryan has published extensively on infant feeding practices, breastfeeding trends, childhood growth and development, body composition, cardiovascular disease, and omega-3 fatty acids. He supervised over 50 clinical trials involving the development of new infant formulas and medical foods. He managed the successful submission of two new drug applications (NDAs): one for Lovaza® (formerly Omacor®), an omega-3 fatty acid drug for the treatment of hypertriglyceridemia, and the second for NeoProfen®, an "orphan" IV drug for the treatment of patent ductus arteriosus in premature infants. As a consultant, Dr. Ryan has prepared protocols for Phase II and III trials, articles for publication, and regulatory materials for IRB approval including Type B meetings. He wrote protocols, articles and final reports for medical food, drugs, and dietary supplements for the treatment and management of cardiovascular disease, pain, CNS disorders, cognitive function, kidney stones, and drug abuse.

Topic Background:

The Orphan Drug Act of 1988 defines a medical food as “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements based on recognized scientific principles are established by medical evaluation.”

Unlike foods for special dietary purposes (such as for preventing a food allergy, making a food easier to swallow, or providing nutrients intended to meet ordinary nutritional requirements) the FDA views medical foods as an integral component of the patient's clinical management.

Efficacy claims for medical foods must be based on sound laboratory practices and clinical data from well-designed studies. Medical foods must be comprised of components designated as “Generally Recognized as Safe (GRAS).” The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition and agreement by experts in the field that the ingredient is safe. There is an expectation that a medical food will help in the treatment of a medical condition. It is not simply a part of an overall diet designed to reduce the risk of a disease or medical condition, to lose or maintain weight, or to ensure the consumption of a healthy diet.

Several pharmaceutical and dietary supplement companies are manufacturing and marketing medical foods. Preclinical safety information and results of well-designed clinical studies are needed for medical food development. In this webinar, examples of new medical food products will be described for a variety of medical conditions.

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