Dockets Management Branch (HFA-305),

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Dear Sir/Madam,

I am pleased to submit these comments on behalf of the National Family
Planning and Reproductive Health Association regarding the proposed new
labeling warning for all over-the-counter vaginal contraceptive drug
products containing nonoxynol-9 \[21 CFR Part 201\].

The National Family Planning and Reproductive Health
Association(NFPRHA), based in Washington, D.C. represents the majority
of the 4,600 clinics nationwide that provide publicly funded family
planning services to low income women and men served at Title X family
planing clinics. Through advocacy, policy analysis, and regulatory
analysis, NFPRHA works to ensure that low-income women and men have
access to a full range of safe, affordable, and voluntary reproductive
health services.

NFPRHA congratulates the FDA on its effort to provide users with
accurate and reliable information regarding the benefits, limitations
and potential risks posed by OTC contraceptive products containing N-9.
The decision to add warning labels to these products strikes the
appropriate balance between preserving women's access to an important
non-hormonal contraceptive option, while countering the widespread
perception that N-9 provides protection against STDs and HIV. NFPRHA
would also like to emphasize, however, that at this point in time,
vaginal spermicides containing N-9, either alone or in combination with
cervical barriers, represent the only non-hormonal, form of
contraception that is fully within the control of women. Thus, despite
the risks posed by N-9 to some users, we believe that it is critical for
women to have access to spermicides currently on the market until safe
and effective alternatives become available.

At the same time, we share the FDA's concern that women may be
inadvertently putting themselves at risk, either because they mistakenly
believe that N-9 products provide protection from HIV and/or STDs or
because they are using N-9 birth control products with a frequency that
could exacerbate any underlying risk of HIV infection. As a result, we
support the FDA's decision to provide additional information to users
via the product label and package insert.

We welcome the opportunity to give input on the FDA's proposed strategy
for re-labeling N-9 containing contraceptives. To increase the chances
that individuals will take notice of the warning, we suggest adding
labeling to the outside package in addition to the warning that appears
on the tube or package insert. In addition, we support the FDA's
addition of a warning regarding the possible danger of frequent use of
N-9 containing contraceptives for women at risk of HIV. We are somewhat
concerned that the definition of "frequent use" as more than once a day,
while having the benefit of providing concrete guidance, overstates the
risk for many women. For example, because the risk results from a
combination of the woman's underlying risk of HIV/AIDS *and* the
prospect of frequent use, a woman at low risk of HIV could safely use
N-9 on multiple occasions in single day. Presumably if a woman is not at
risk of HIV (because she is in a mutually monogamous relationship with
an HIV negative partner), then frequent use of N-9 poses no additional
hazard. And while we generally prefer to err on the side of caution, we
are not completely convinced that the once per day limit for vaginal use
is supported by the available scientific evidence.

Also, the current reference to "vaginal irritation" many leave women
with the mistaken impression that if they do not subjectively perceive
"irritation," they are safe. The FDA could alter the wording to suggest
that frequent use of this product can damage the cells lining the
vagina, a condition which may increase one's risk of becoming infected
with HIV or other STDs if exposed to an infected partner.

We also suggest that, rather than urging women to seek guidance on N-9
use from a physician, that the label explicitly state that women who may
be at risk of HIV and who plan to use the product frequently consider
another form of birth control. The label could clarify that vaginal
contraceptive products containing N-9 remain a safe contraceptive option
for women at low risk of HIV. Language should also be added to reinforce
that correct use of a latex condom with every sexual act will help
reduce the risk of contracting HIV and other STDs.

Finally, we strongly suggest that this language be altered to offer an
explicit warning against using these products rectally. Even though the
products are designed for vaginal *contraceptive* use, they can and are
used during anal intercourse. Studies confirm that N-9 is even more
toxic when used rectally. Given the high likelihood of harm posed by the
*[misuse]{.underline}* of OTC contraceptive products rectally, we
recommend that the label include an explicit warning against rectal use
of these products. Because of this danger, we request FDA to take action
to address the potential health risks posed by N-9 as an additive on
condoms and in sexual lubricants. N-9 is not necessary to the
functioning of these products either as lubricants or in the case of
condoms, in their role as physical barriers against pregnancy and
disease.

In closing, we would like to emphasize the urgent need for products that
unlike N-9, *[do]{.underline}* hold promise for providing safe and
effective protection against sexually transmitted infections, including
HIV. Additionally, given the complex safety profile of N-9, we need new
vaginal contraceptive products that can be used alone, or in combination
with the diaphragm or other cervical barrier, to prevent unwanted
pregnancy.

Thank you for the opportunity to comment.

Sincerely,

Marilyn Keefe

Vice President for Public Policy Association

National Family Planning and Reproductive Health

1627 K St. NW

Washington, D.C. 20006