Bioethics expert R. Alta Charo is joining the U.S. Food and Drug Administration as a senior adviser to FDA Commissioner Margaret Hamburg. In an interview Wednesday, Hamburg said that Charo will be involved in many cutting-edge fields. "I expect that we will quickly make use of her as we think about strategies on how to address the review of products in the arena of personalized medicine, in-vitro diagnostics, stem-cell therapies, where she's already done important work," Hamburg said.
Charo, on the law faculty of the University of Wisconsin, Madison, has written extensively on the ethics of embryonic stem cell research, served on President Barack Obama's FDA transition team, and was a member of President Bill Clinton's bioethics advisory council. Charo's influence at FDA will be "broader than bioethics," said Hamburg."She also is an expert on food and drug law," areas in which her advice will be welcome. The FDA director said that she and her staff are looking forward to working with the National Institutes of Health on establishing a regulatory framework for assessing new medical diagnostics and treatments. "I think that, working together, we will be able to put in place a strategic framework to make sure that the scientific opportunities can translate into available products, with appropriate regulatory review." Charo has said that she hopes to focus on developing a comprehensive approach to regulating genetic tests.