New post at M. Revolution:
Each of the leading nominees also understands that we are entering a brand new world of personalized medicine that may require changes in the way in which the FDA approves medical devices and drugs. Smartphones equipped with detectors perform ECGs, can monitor blood pressure and even examine DNA. Other devices being accessible or developed contain contact lens that can track glucose levels and eye pressure, devices for tracking and analyzing gait in head bands and real time that monitor and even fix your brain waves.
The FDA has an inconsistent even schizophrenic approach towards these brand new apparatus—some have been approved and yet at exactly the same time the FDA has banned 23andMe and other direct-to-consumer genetic testing businesses from offering some DNA tests because of “the danger that a test result could be utilized by a patient to self-manage”. If someone is looking for nearby sushi but their DNA test says they’re allergic to fish, will the FDA be able to provide insurers with this type of information in a way that it can impact the end consumer? But the FDA shouldn’t be restricting the information that patients may detect about the guidance which will be given based on such an info or their particular bodies. Interference of the sort breaks the first amendment and the longstanding doctrine that the FDA does not control the practice of medicine.
Srinivisan is an electrical engineer and a computer scientist who has additionally printed in the New England Journal of Medicine, Nature Biotechnology, and Nature Reviews Genetics. He’s a co founder of Counsyl, a genetic testing firm that now examines ~4% of all US births, so he understands the significance of the brand new world of personalized medicine.