The U.S. Food and Drug Administration (FDA) and New York’s attorney general have announced new policing strategies against for-profit clinics that offer expensive and unapproved stem cell treatments for a variety of conditions.
The FDA sent 20 letters to stem cell companies, asking them to cease selling unapproved products, which is a violation of federal laws. The FDA also sent a formal warning letter to Cord for Life, a company based in Altamonte Springs, Florida, that has sold umbilical cord blood products to stem cell companies. In the letter, the cord-banking company was cited for lapses in safety measures, including failing to follow specific sterility procedures or properly document its tests and equipment.
In New York, the attorney general filed a lawsuit against Park Avenue Stem Cell, a clinic in Manhattan that is accused of engaging in “fraudulent and illegal advertising regarding its stem cell procedures.”
The latest steps are part of an ongoing effort on behalf of the FDA and state-level regulators to rein in a quickly growing industry that, according to the agencies, has injured at least two dozen patients and cheated countless others.
However, critics question whether the warning letters will have a substantial impact on these clinics’ operations. “It’s not that these letters are inconsequential,” said Leigh Turner, PhD, a bioethicist from the University of Minnesota who has studied the industry’s growth. “But if you’re trying to tackle this one business at a time, you’re not going to make a dent.”
Sources: The Wall Street Journal, April 3, 2019; The Scientist, April 8, 2019.