www.fdanews.com/articles/148343-pharma-blog-watch
Pharma Blog Watch
August 1, 2012
Setting a Stage for the Stem Cell War (Pharmalot blog)
For the past few years, the FDA and Regenerative Sciences (RS) have been locked in a dispute — RS claiming it was medical practice to use stem cells to perform non-surgical procedures. “The FDA, however, argues the procedure actually amounted to the use of drugs that were never approved under a biologics license application or new drug application,” blogger Ed Silverman writes. Following FDA inspections, RS fired back a lawsuit claiming the FDA was out of jurisdiction. Silverman adds, “while calling it a close call, a federal judge last week ruled in favor of the FDA and agreed the agency has the right to regulate therapies made from a patient’s own processed stem cells, setting the stage for oversight of a largely unregulated field.”
For the past few years, the FDA and Regenerative Sciences (RS) have been locked in a dispute — RS claiming it was medical practice to use stem cells to perform non-surgical procedures. “The FDA, however, argues the procedure actually amounted to the use of drugs that were never approved under a biologics license application or new drug application,” blogger Ed Silverman writes. Following FDA inspections, RS fired back a lawsuit claiming the FDA was out of jurisdiction. Silverman adds, “while calling it a close call, a federal judge last week ruled in favor of the FDA and agreed the agency has the right to regulate therapies made from a patient’s own processed stem cells, setting the stage for oversight of a largely unregulated field.”