The Food and Drug Administration has announced plans to
hand over management of drug safety issues to an
independent Drug Safety Oversight Board, through which
it will release information on the “emerging” risks and
benefits of medicines.
The Department of Health and Human Services said creating
the board is consistent with FDA reforms promoting
greater oversight, openness and “enhanced independence.”
“They want to know what we know, what we do with the
information and why we do it. We will address their
concerns by cultivating openness and enhanced independence,”
said Leavitt in a recent meeting with FDA employees.
According to HHS, the board will oversee the management
of safety issues such as the “drug watch,” resolving
disagreements over how to approach safety issues,
assessing the need for MedGuides and overseeing the
development and implementation of center-wide drug
safety policies.
FDA members and medical experts from other HHS agencies
and other departments, such as Veterans Affairs will
consult with outside medical experts and representatives
from patient and consumer groups, according to HHS.
