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: FDA
As Genetic Testing for Breast Cancer Gene Mutation Expands, Questions Arise About Treatment Decisions
posted by: Katherine Drabiak, J.D.
May 18, 2018
This post originally appeared on The Conversation on May 3, 2018. The Food and Drug Administration recently announced its authorization that permits genetics testing company 23andMe to market a test for gene mutations associated with risk of breast and ovarian cancer. In response, 23andMe CEO Anne Wojcicki asserted that...
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...
Questions about Deaths in Cancer Trials using Gene-Altered Cells
posted by: Katherine Drabiak, J.D.
January 9, 2017
This article was originally posted on The Center for Genetics and Society’s site here. In the past month, the media has reported seven patient deaths of subjects enrolled in separate gene therapy clinical trials being conducted by Juno Therapeutics and by Ziopharm Oncology, Inc., both...
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...