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
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.