Floyd E. Leaders Jr., Ph.D., a pharmacist and pharmacologist who researched botanical drug development, died Feb. 26 after a long illness. He was 7
In the early 1990s, Leaders became a regulatory consultant to the National Institute of Health's Office of Alternative Medicine. There, he helped manufacturers file Investigational New Drug applications for botanical products with the Food and Drug Administration Center for Drug Evaluation and Research. Leaders also co-chaired numerous workshops on developing botanicals as drugs.
"Floyd Leaders played a pivotal role in the historical evolution of U.S. regulatory policy at the FDA," said Freddie Ann Hoffman, managing member, HeteroGeneity LLC, a Washington, D.C.-based consultancy on regulatory policy and development of botanicals, and former deputy director of the FDA's Botanical Working Group. "In his collegial and pragmatic manner, Floyd quietly challenged the excessive safety requirements and 'combination rule' that the FDA had arbitrarily imposed on nutritional products and ingredients that could be found at your local supermarket or had been used by humans for thousands of years.
"He ignited the FDA into clarifying its regulations and policies, stimulating in the process its development of a Guidance for Industry document on botanical drugs. Had he not been outside of the agency, pushing inward, the FDA might not have realized it had to respond to this issue."
Mark Blumenthal, executive director of the Austin, Texas-based American Botanical Council, also believes Leaders was "instrumental in helping create a significant bridge of communication and understanding between the herb industry and botanical researchers, on the one hand, and many scientists and policymakers at the FDA on the other—especially at a pivotal time in the development of the herb movement, just after the passage of the Dietary Supplement Health and Education Act of 199
At the time of his death, Leaders was chairman and CEO of Botanical Enterprises Inc. in Rockville, Md., where he developed botanical drug products.
Leaders is survived by his wife, Madeline van Hoose, and his daughter, Terra Singletary.
Natural Foods Merchandiser volume XXVII/number 4/p. 12