With Stem Cell Therapy Guidelines, FDA Aims To Boost Innovation But Crack Down On Rogue Clinics
As the promising field has taken off in the past few years, unregulated clinics have sprung up, charging patients thousands of dollars for untested treatments.
The New York Times:
F.D.A. Speeds Review Of Gene Therapies, Vowing To Target Rogue Clinics
The Food and Drug Administration on Thursday issued new guidelines to speed the introduction of treatments involving human cells and tissues, including gene therapy. But the agency also said it would crack down on rogue clinics offering dangerous or unproven versions of those treatments. The therapies aimed at diseases like leukemia are known as regenerative medicine and have quickly grown into a booming industry worldwide. (Kaplan and Grady, 11/16)
Stat:
FDA Lays Out Long-Awaited Guidelines For Stem Cell Treatments
The Food and Drug Administration on Thursday unveiled a series of guidelines that aim to encourage the development of promising and legitimate stem cell therapies while distinguishing them from the largely untested stem cell treatments hawked by unregulated clinics around the country. The FDA’s guidelines have been expected and eagerly awaited by the stem cell community given the rapid proliferation of untested — and potentially unsafe — therapies around the country. Clinics promoting these therapies claim to be able to treat ailments from autism to neurodegenerative disorders to erectile dysfunction. (Joseph, 11/16)
San Francisco Chronicle:
US Sets Rules On Stem Cell Therapies
The carefully worded guidelines underscore the narrow path regulators walk between allowing, and even hastening, approval of potentially life-changing cellular therapies and preventing providers from selling unproven and possibly dangerous cell products directly to patients. “The promise of this technology is why the FDA is so committed to encouraging and supporting innovation in this field,” agency Commissioner Scott Gottlieb said in a statement released with the guidelines. “But the rapid growth and promise of this field has increasingly sowed the ground for the entry of some unscrupulous actors.” (Allday, 11/16)
In related news —
The Washington Post:
In A First, Scientists Edit Genes Inside A Man’s Body To Try To Cure A Disease. What’s Next?
Scientists have attempted to cure a patient with a rare genetic disorder by rewriting the DNA inside his body, in a first-of-its-kind therapy they hope could one day be applied to numerous other conditions including hemophilia and sickle cell disease. The procedure, which took place on Monday at the University of California at San Francisco's Benioff Children's Hospital in Oakland, Calif., involved sending what the Associated Press described as “billions of copies of a corrective gene and a genetic tool to cut his DNA in a precise spot” into the patient's body. These edits are designed to enable the patient, 44-year-old Brian Madeux, to produce an enzyme that would counteract a metabolic disease he suffers from known as Hunter syndrome. (Cha, 11/16)
