opinion
Does the FDA even know how to regulate MDMA therapy?
Thomas Insel, who once led the National Institute of Mental Health, was not at all surprised last month that an FDA advisory committee voted against approving MDMA-assisted psychotherapy for PTSD. Opining for STAT, Insel writes that the FDA generally overlooks the significant role psychotherapy plays in the efficacy of psychiatric drugs — and that this must change.
"The combination is the overlooked innovation of this new drug application," Insel writes. "People with severe mental illnesses need a regulatory process that addresses this innovation as a feature, not a bug."
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opinion
DOJ misconstruing kickbacks for rare disease testing
Advances in genetic testing are making it easier to identify rare diseases — but the testing is rarely covered by insurers. When biotechs step in and offer to pay for testing, however, the Department of Justice has begun to call these "kickbacks" to the physician making the orders. This impedes care for many rare disease patients who are already on a painful diagnostic odyssey, opines Emil Kakis, CEO of Ultragenyx, a biotech specializing in ultra-rare disease.
Ultragenyx and other biotechs are under DOJ investigation, Kakis notes, for sponsoring testing for a rare disorder.
"There were no kickbacks or false claims," he writes. "Without the tests we sponsored, many patients ultimately diagnosed with the disorder would continue to suffer from an unknown disease without proper care."
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