UW-Madison medical ethicist heading to FDA

UW-Madison professor of law R. Alta Charo has accepted a position as senior adviser in the Office of the Commissioner at the Food and Drug Administration, effective Aug. 30.

Charo, who will remain a UW–Madison employee during her one-year tenure, says the FDA “regulates products that represent 25 cents of every dollar spent by consumers, it’s not just drugs and medical devices, but the blood supply, vaccines, nutritional supplements, most foods except for meat, and even cosmetics.”

Charo, a national expert on bioethics, will be joining “a small group of people who will form a think tank within the commissioner’s office to step outside the pressure of day-to-day business and think more strategically about comprehensive approaches to new challenges for the agency.”

One likely topic will be the largely unregulated genetic tests that are now being marketed directly to consumers, Charo says. “We now have a very limited system for ensuring analytic quality. How often does the test tell you what it claims to tell you? And there is no system for evaluating clinical utility. How can you know whether the test results mean anything?”

Charo, who served on the Obama administration’s FDA transition team and was a member of President Clinton’s bioethics advisory council, says any future regulation should not hinder legitimate scientific and medical uses. “Genetic testing can be used to figure out if the swine flu virus in Wisconsin is the same as the virus in Mexico, and we don’t want regulation to slow the response to an epidemic,” she says.

Charo says she found the FDA offer irresistible. “It is an intellectual feast; it’s impossible to resist the chance to take what I find fascinating at a scholarly level and use it to make my own little corner of the world a better place.”

If mutually agreed, the position may be extended for a second year, Charo adds.