Food and Drug
Administration
Center for Drug Evaluation and Research (CDER)
Advisory Committee
for Reproductive Health Drugs
December 15, 2003
Hilton Grand Ballroom
620 Perry Parkway, Gaithersburg, MD
Questions to the Committee
- Are
further increases in folic acid intake, beyond what is available from
fortified cereals, likely to result in public health advances in
preventing further neural tube defects?
- Can we
define a subpopulation among women of reproductive age that needs
additional folic acid? If yes,
what subpopulation should receive additional folic acid and how would you
identify this population?
- Are there any safety issues associated with folic acid
supplementation targeted at reproductive-age women? If so,
a. What are
they?
b. Would
these safety issues not be a concern below a certain level of
supplementation? If so, what is that
level?
- Would
the benefit of prior folic acid use persist if conception occurs after
discontinuation of folic acid? If
so, for how long will the benefit persist?
- Is an
oral contraceptive pill a reasonable delivery vehicle if additional folic
acid supplementation is likely to provide public health advances in
preventing further neural tube defects?
a.
If so, would 400 mcg be a reasonable dose?
b.
If 400 mcg is not appropriate, what dose of folic acid should be provided?