Diane Hoffmann, Director of the Law and Health Care Program and Jacob A. France Professor of Health Care Law at the University of Maryland Francis King Carey School of Law, co-authored an article that was published in the December issue of Science providing the framework for an improved regulatory scheme governing fecal microbiota transplants (FMT).
Placing an article in Science is a noteworthy achievement in itself, but the story of interprofessional collaboration that underlies that article is just as significant.
Professor Hoffmann’s co-authors from the University of Maryland, Baltimore (UMB) are: Dr. Francis Palumbo from the School of Pharmacy; Dr. Jacques Ravel, Dr. Mary-Claire Roghmann, and Dr. Erik von Rosenvinge from the School of Medicine; and Virginia Rowthorn from UMB’s Center for Global Education Initiatives.
FMT has only recently become the standard of care for recurrent Clostridium difficile infection (colloquially referred to as C.Diff), and, as with any emerging medical technology, there is a need for a regulatory regime that balances innovation and practice with patient safety.
To that end, the authors reviewed existing regulatory frameworks the US Food and Drug Administration utilizes and weighed the risks and benefits associated with each. The article, “Improving Regulation of Microbiota Transplants,” takes the best fitting regulatory regimes, and advocates for a three-tier approach to regulating FMT, including the first regulation of stool banks.
A Decade of Collaboration
In 2008 the National Institute for Health (NIH) established the Human Microbiome Project to fund research on the nascent field. A portion of that funding was set aside to study the ethical, legal and social issues related to research on the human microbiome. When that call for proposals went out, Director of the Institute for Genome Sciences at UMB’s School of Medicine, Dr. Claire Frasier, got in touch with Karen Rothenberg, then dean of Maryland Carey Law, seeking partners for a potential project. That first contact would be the catalyst to a decade of collaboration.
Almost immediately the duo became six. Professor Hoffmann explains, “Dr. Fraser brought her colleague Jacques Ravel, I invited Frank Palumbo from the School of Pharmacy as well as Jack Schwartz, a law school adjunct professor, to the team. Virginia Rowthorn, from Maryland Carey Law, also worked with me on the project.”
Years after the first partnerships were formed, Professor Hoffman describes the assembly of the team for the latest NIH grant and Science article, “Although Dr. Fraser was unable to participate, I reached out to Mary-Claire Roghmann who I had gotten to know through other campus committees. As an infectious disease doctor, she was a great addition to our team. Dr. Roghmann then suggested Eric von Rosenvinge, a gastroenterologist at the Medical School who had actually performed fecal microbiota transplants on his patients. His input was invaluable to our work. The fact that I had known Prof. Palumbo from the School of Pharmacy because he is a member of the adjunct faculty at Carey Law, made that connection very easy.”
Professor Hoffmann’s work on the Human Microbiome Project has spawned a multidisciplinary working group that includes “about 25 individuals, some who were human microbiome scientists, others who were clinicians, food & drug law attorneys, legal academics, bioethicists, patient representatives, regulators, and industry representatives.”
Work continues at the end of February when the group of scholars meets again to review the Science article, discuss emerging areas of microbiome research and practice, and hear presentations from two microbiology companies offering personalized microbiome testing.