February 13, 2006

The Food and Drug Administration,

Center for Devices and Radiological Health

The Division of Small Manufacturers, International

And Consumer Assistance

1350 Piccard Drive

Rockville, MD 20850

**RE: Comments on FDA Condom Labeling Guidelines**

** (Docket No. 2004D-0555)**

To Whom It May Concern:

The AIDS Institute is pleased to offer comments to the Food and Drug
Administration on the Class II Special Controls Guidance Document:*
Labeling for Male Condoms Made of Natural Rubber Latex *published in the
*Federal Register* on November 14, 2005.

The AIDS Institute is a national public policy research, advocacy, and
education agency in Washington, DC. As an organization that is dedicated
to sound HIV/AIDS and Hepatitis public policy, including policies that
prevent the spread of HIV and Hepatitis, the proper labeling of condoms
are vitally important. It is of utmost importance that all labeling be
based on sound scientific evidence and is medically accurate. We are
pleased that the proposed labeling guideline changes appear to be
consistent with the current published scientific evidence about condom
effectiveness. The AIDS Institute hopes the final guidance for condom
labeling will continue to reflect these same principles.

**[Recommendations for Condom Labeling Guidelines]{.underline}**

Both FDA labeling guidelines and condom package information should
adequately inform users of the risks and benefits. Label information
should continue to convey the fact that condoms remain a highly
effective form of protection against HIV and STDs, such as Hepatitis
B.  Any confusion regarding risks and benefits that might scare sexually
active individuals away from condom use poses a serious threat to the
public's health.

When used correctly and consistently, the male condom is a safe and
effective means of reducing the risk of HIV, sexually transmitted
infections (STIs), and other sexually transmitted diseases (STDs). In
the words of a 2000 NIH report on condom effectiveness, the male condom
is "essentially impermeable" to even the smallest of sexually
transmissible viruses. The NIH's report proves that condoms do work when
used correctly and must remain a key component of HIV and STI prevention
efforts both in the United States and globally. Therefore, we support
the FDA statement that for HIV/AIDS, condom "labeling should indicate
that latex condoms can greatly reduce, but do not eliminate, the risk of
HIV transmission."

For other STDs, such as Hepatitis B, that are transmitted in various
ways, including

transmission to or from the penis and transmission by other types of
sexual contact, we agree with the FDA statement that condom "labeling
should indicate that latex condoms

can help reduce the risk of STD transmission to or from the penis, but
that some STDs can also be transmitted by other types of sexual
contact."

For STDs, such as chlamydia and gonorrhea, that are transmitted to or
from the penis by contact with the vagina and genital fluids, we support
the FDA statement that condom "labeling should indicate that latex
condoms can reduce the risk of STDs transmitted to or from the penis by
contact with the vagina or genital fluids, such as chlamydia and
gonorrhea."

Finally, for STDs, such as genital herpes and human papillomavirus (HPV)
infection, that can be transmitted by contact with skin outside the area
covered by a condom, as well as by contact with the penis, we support
the FDA statement that condom "labeling should indicate that latex
condoms provide less protection for those STDs that can also be
transmitted by contact with skin outside the area covered by a condom,
such as genital herpes and HPV. Labeling should clarify that consistent
use of condoms may provide some benefit for these STDs, such as reduced
risk of herpes infection or reduced risk of developing HPV-related
diseases."

The AIDS Institute recognizes that the FDA has been under pressure to
completely minimize the role condoms can play in preventing HPV
infection. We thank you for basing your draft guidelines on scientific
evidence, rather than on these unscientific pressures.