Bioethicist Joins FDA to Help with Ped Trials

Article excerpt

Bioethicist Sara Goldkind has joined the Food and Drug Administration's Office of Pediatric Therapeutics in the Office of the Commissioner.

In 2001, when Congress reauthorized the statutory incentives for pediatric clinical trials, it mandated that the FDA establish the Office of Pediatric Therapeutics and include a bioethicist on staff.

The American Academy of Pediatrics drafted ethical guidelines for the study of drugs in pediatric patients, and several of the academy's recommendations were incorporated into the FDA's regulations. As part of her charter, Dr. Goldkind "will work with those regulations that relate to studies that are done with greater than minimal risk for generalizable information rather than for direct patient information or direct patient benefit."

She also will sit on several established FDA ethics panels, including a neonatal ethics working group and a pediatrics working group. Dr. Goldkind will work with the FDA's Office of Human Research Protections. Health and Human Services, and the National Institutes of Health, and play a consultative role with clinical trial designers at pharmaceutical companies. …