FULL ARTICLE LINK: Genetic Engineering and Biotechnology News
Keep the Opportunities, Lose the Opportunists
Authors: Graham Parker, Ph.D. and Jeanne F. Loring, Ph.D.
A recent article focused attention on the proliferation of unregulated clinics in the U.S. that promise stem cell cures. The term “stem cell” used to have meaning only to scientists. It referred to cells that can both make new copies of themselves and turn into different types of mature cells.
The FDA has been slow to enforce their oversight of these clinics by any meaningful action, and this regrettably has, if not condoned, permitted the proliferation of sites offering perceived unregulated stem cell treatments. But happily this is changing. At the World Stem Cell Summit in 2015, Robert Califf, M.D., the FDA Commissioner, told the gathering of scientists, clinicians, and patient advocate attendees that the FDA is willing to consider complaints about any specific clinic.
On September 12th-13th (9AM-5PM) Eastern Standard Time, the FDA will hold a two day public hearing on their proposed changes to regulations of stem cell therapies. This meeting, called “Part 15 Hearing on Draft Guidance’s Relating to the Regulation of HCT/Ps [Human Cells, Tissues, and Cellular and Tissue-Based Products],” will be held at the NIH headquarters in Bethesda, MD. There are 54 clinics or organizations scheduled to speak at this meeting and forty individuals.
Persons (including FDA employees) seeking to view the hearing via a live Webcast are not required to register. A link to the Webcast will be made available on this web page.