
Mon Sep 09 15:07:34 UTC 2024: ## Personalized Medicine: A Future Held Back by Regulation?
A new article by Eugene Volokh, a law professor and libertarian thinker, argues that personalized medicine, using technology like at-home DNA testing and personal omics profiling, has the potential to revolutionize healthcare. He points to the growing availability of real-time, at-home tests and devices, citing pregnancy tests, COVID tests, and wearables like Fitbits as examples.
Volokh highlights the potential of personal omics profiles, which can provide a comprehensive picture of a person’s health across multiple biological factors, to tailor treatments to specific individuals at specific times. He argues that this technology could optimize healthcare strategies in a way that traditional medicine hasn’t been able to achieve.
However, he notes that the progress of personalized medicine has been slowed by the U.S. Food and Drug Administration (FDA), citing the agency’s stringent regulations as a barrier to adoption and increased costs for these tests and devices. He uses the example of home pregnancy tests, which were initially banned by the FDA in 1972 but later became widely accessible after a court ruling that pregnancy is not a disease.
Volokh suggests that the FDA’s cautious approach to personalized medicine, stemming from its fear of potential risks, might be hindering the development of a valuable and potentially life-saving field. He argues that a more flexible and streamlined regulatory approach could pave the way for a future where personalized medicine plays a much larger role in healthcare.