FDA Answers Public's Concerns

Pharmacy Times, Volume 0, 0

Plans are under way to develop anew independent Drug Safety OversightBoard to supervise the managementof drug safety issues, accordingto Department of Health and HumanServices (HHS) Secretary Mike Leavitt.The board's tasks include overseeingsafety issues such as recommendinginformation and updates for placementon the FDA Drug Watch; resolvingdisagreements over approaches todrug safety issues; evaluating the needfor MedGuides; and managing developmentand implementation of Centerfor Drug Evaluation and Researchdrug safety policies.

The board will include membersfrom the FDA and medical expertsfrom other HHS agencies and governmentdepartments. The board alsowill consult with outside medicalexperts and representatives of patientand consumer groups. Furthermore,the FDA will initiate a new DrugWatch Web page and share tailoreddrug safety information sheets withhealth care professionals and consumergroups.

"The public has spoken, and theywant more oversight and openness,"said Leavitt. "They want to know whatwe know, what we do with the information,and why we do it. We will addresstheir concerns by cultivating opennessand enhanced independence."