Plans are under way to develop a
new independent Drug Safety Oversight
Board to supervise the management
of drug safety issues, according
to Department of Health and Human
Services (HHS) Secretary Mike Leavitt.
The board's tasks include overseeing
safety issues such as recommending
information and updates for placement
on the FDA Drug Watch; resolving
disagreements over approaches to
drug safety issues; evaluating the need
for MedGuides; and managing development
and implementation of Center
for Drug Evaluation and Research
drug safety policies.
The board will include members
from the FDA and medical experts
from other HHS agencies and government
departments. The board also
will consult with outside medical
experts and representatives of patient
and consumer groups. Furthermore,
the FDA will initiate a new Drug
Watch Web page and share tailored
drug safety information sheets with
health care professionals and consumer
groups.
"The public has spoken, and they
want more oversight and openness,"
said Leavitt. "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."