Does the FDA need to protect you from information about your genome, especially if some of that information is potentially unreliable? Or should anyone be able to buy a tentative analysis of their genome based on the latest research?
It sounds great in principle, but the result is a major headache for the FDA, because modern genetic medicine is demolishing regulatory concepts and categories that the agency has long used to ensure that drugs and diagnostics are safe and effective.
Take genetic tests for instance. The two primary criteria the FDA uses to evaluate diagnostics are analytical validity and clinical validity. A typical diagnostic test is required to be both analytically and clinically valid, but for large-scale genetic tests this doesn’t make sense.
Read the full, original story: The FDA Is Not Anti-Genetics
- First FDA Authorization for Next-Generation Sequencer, New England Journal of Medicine
- Seeing Over the Health Care Horizon, Huffington Post
- Regulation: The FDA is overcautious on consumer genomics, Nature