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|Newsletters: Dr. Kelly Represents Oley Consumers at FDA Meeting|
Dr. Kelly Represents Oley Consumers at FDA Meeting (10/2013)
A week after Clinolipid was approved, the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) and the FDA co-sponsored a seminar on clinical trial design for IV fat emulsion products. Joan Bishop, Oley Executive Director, and Dr. Darlene Kelly, Oley Science and Medicine Advisor, were there to represent you, the home parenteral nutrition consumer. Also attending were approximately one hundred people from industry, research labs, and parenteral nutrition practices, and hundreds more joined via Webcast.
Historical background, the metabolism of various components of the emulsions, and clinical observations from Europe and other locations around the world that are using several different IV fat emulsion products were presented. A.S.P.E.N. notes, “During this forum, lively discussions on clinical endpoints and trial design were held.” Attendees discussed the challenges related to selecting populations for trials, and the problems associated with assessment methodologies.
There was limited opportunity for public discussion, but Dr. Kelly was able to make a short presentation. “I represent the 13,000+ members of the non-profit Oley Foundation for home parenteral and enteral nutrition,” she explained. “I recently retired as medical director of the Home Parenteral Nutrition Program at the Mayo Clinic, Rochester, after twenty-two years of managing over 1,200 patients on this therapy. Since home parenteral nutrition was introduced in 1967, the only lipids [IV fats] ever approved by FDA were soybean-safflower products, with approval granted twenty-two years ago. National shortage of Intralipid forced urgent release of a single newer product last week [Clinolipid], but until then only Intralipid was available. The inability to use newer alternate lipid emulsions has long frustrated clinicians who realize that a subset of patients appears to be sensitive to the lipid and these often develop liver complications.”
Dr. Kelly and several members of the audience encouraged the FDA to consider approving new lipid emulsions on a basis of non-inferiority compared to Intralipid as opposed to superiority to Intralipid. Furthermore, it was recommended that nutritional criteria rather than other therapeutic criteria be considered. This was regarded as the quickest and most efficient route to getting FDA approval for alternate lipids.
LifelineLetter, November/December 2013