FOOD AND
DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
(CDER)
Drug Safety and Risk Management
Advisory Committee (DSaRM)
Holiday Inn
May 18 & 19,
2005
QUESTIONS
You have seen the FDA portfolio of post-market drug
surveillance approaches and observational study methods. Please discuss the best use of these methods
and approaches to assess risks of marketed drugs.
DAY 2 THURSDAY MAY 19, 2005
Please comment on the following topics and questions:
1. Under
what circumstances are each of the following types of
studies best suited to detect or quantify a risk in the post-marketing setting:
a. An epidemiological
study?
b. A
clinical trial?
c. A
registry?
2. In
light of the time and effort entailed in conducting population-based studies:
a. What kinds of safety problems are best
studied by these methods?
b. What criteria should be used to
prioritize drug safety signals for quantification in
population-based
studies?
3. What
are the best avenues for FDA to strategically expand its access to data needed
to conduct population-based studies to evaluate the safety of marketed
drugs? Examples include, but are not
limited to, Federal organizations (VA, DoD, CMS, others), health care benefits
programs (such as Medicaid, managed care organizations, and FFS programs), and
foreign sources (GPRD,
4. Based on the discussions over the past two days, please
offer strategic advice on how our
data systems could be strengthened in the following
timeframes:
a.
Short-term (6 months - 18 months)
b. Long-term (18 months – 5 years)