In summer 2019, the Congressional Appropriations Committee voted to reinstate a rider to the Consolidated Appropriations Act that prohibits the FDA from reviewing clinical applications in which a human embryo would be intentionally created or modified to include a heritable genetic modification. Prior to this vote,...
Tag: Genomics
Public Comments to Singapore’s Bioethics Advisory Committee on Mitochondrial Replacement Therapy
posted by: Katherine Drabiak, J.D.
July 26, 2018
In the Spring of 2018, Singapore issued a call for Public Comments on the topic of whether it should repeal the country’s current prohibition against germline modification of embryos and permit an exception for Mitochondrial Replacement Therapy. See the story here and here. ...
Engineering Consensus in the Development of Genome Editing Policy
posted by: Katherine Drabiak, J.D.
March 14, 2017
This commentary was originally published as an Essay on the Hastings Center Bioethics Forum here. In the past few weeks media outlets have been reporting on the release of Human Genome Editing: Science, Ethics, and Governance from the National Academies of Science, Engineering, and...
The Problem of Transparency and Human Genome Editing
posted by: Katherine Drabiak, J.D.
June 4, 2016
In the past several weeks, human genetic modification has been dominating headlines. This time, the controversy surrounded the closed door meeting between 130 scientists, attorneys, entrepreneurs, and government officials to discuss the creation of a synthetic human genome. The project, called “Human Genome Project-Write...
Read the Fine Print Before You Send Your Spit to 23andMe
posted by: Katherine Drabiak, J.D.
April 7, 2016
Our genomic sequence constitutes the most sensitive and personal of information: uniquely identifying us, revealing our propensity to develop certain diseases and conditions, and exposing familial connections of close genetic relatives. In recent years, Big Data has taken firm hold in numerous sectors, revolutionizing the volume and...
Laboratory Developed Tests Under Scrutiny: FDA Questions Validity and Utility of Oncotype Dx and Prolaris Tests for Personalized Cancer Treatment
posted by: Katherine Drabiak, J.D.
March 8, 2016
In November 2015, FDA published a startling report, The Public Health Evidence for FDA Oversight of Laboratory Developed Tests, which enumerated serious concerns with the current framework it uses to oversee laboratory developed tests (LDTs). LDTs are tests used by physicians to diagnose disease, predict...