Is FDA putting gay men at risk?

[via Bay Windows]
Thursday Jan 10, 2008

"...the small amount of N-9 they (condoms) contain is dangerous if used rectally and offers no documented contraceptive benefit."

The Food and Drug Administration (FDA) announced in December that it is adopting a new rule that would require warning labels on contraceptive products that contain the spermicide nonoxynol-9 (N-9) but the federal agency is delaying the establishment of a similar rule on condoms containing N-9.

The Deputy Director for the Global Campaign for Microbicides, Anna Forbes, said it appeared to her that the FDA was "stalling" on the implementation of the N-9 rules.

Microbicides refer to a wide range of topically applied products including gels, creams and suppositories that prevent the transmission of AIDS and other STDs. The Global Campaign is a nonprofit organization that works with a network of over 285 non-governmental organizations to help accelerate the development of microbicides. It has called for the removal of N-9 from all condoms.

The FDA is considering labeling requirements for N-9 condoms separately from other N-9 contraceptive products because it classifies condoms as "medical devices." The two major manufacturers of N-9 condoms, Church and Dwight, the makers of the Trojan brand, and Ansell, the maker of the LifeStyles brand, wrote to the FDA suggesting that warning consumers about N-9 condoms could be confusing and could stop some consumers from using condoms at all. That objection was the major factor in causing the FDA to delay N-9 labeling rules.

Citing that reason, the FDA opted to study the issue further. The first phase of the planned N-9 condom study will be completed by February 2008 and the second phase, which will take about 17 weeks, will begin after the FDA analyzes the first study, according to FDA spokeswoman Peper Long.

A number of AIDS organizations have joined with the Global Campaign in calling for the removal of N-9 from condoms.

In an advisory letter to the FDA last year, Fred Dillon, who was then the San Francisco AIDS Foundation’s Public Policy and Communications Director, wrote: "[T]he San Francisco AIDS Foundation has joined with a broad coalition of women’s health groups, HIV/AIDS organizations, state and local public health officials, and research scientists calling on manufacturers to remove N-9 from condoms and lubricants, because the small amount of N-9 they contain is dangerous if used rectally and offers no documented contraceptive benefit. While there has been progress on this front, we are disappointed that some companies continue to produce N-9 condoms. The San Francisco AIDS Foundation strongly encourages the FDA to take immediate steps to end the manufacturing or sale."

Read the rest.

Read another LifeLube post on this topic.

Learn more about the development of safe and effective rectal microbicides.