Monday, November 14, 2005

FDA Proposes New Rules for Condoms

The US Food and Drug Administration is proposing new rules for condom labeling. Of course, they can't just say that, so the document published in the Federal Register will make you pull your hair out while you wait for them to get to the point. And the point is that some congresscritters got all upset about condoms in 2000 (I'm thinking this was Dr. Tom Coburn, then Representative from Oklahoma, now Senator Coburn), and stuck a requirement in HR 4577, the Consolidated Appropriations Act for Fy 2000, now PL 106-554 (PDF, pp. 74-75) for a whole new look at condom labeling.

Here's what PL 106-554 says about condoms:

(1) IN GENERAL.—The Secretary shall prepare and distribute educational materials for health care providers and the public that include information on HPV. Such materials shall address—
(A) modes of transmission;
(B) consequences of infection, including the link between HPV and cervical cancer;
(C) the available scientific evidence on the effectiveness or lack of effectiveness of condoms in preventing infection with HPV; and
(D) the importance of regular Pap smears, and other diagnostics for early intervention and prevention of cervical cancer purposes in preventing cervical cancer.
(2) MEDICALLY ACCURATE INFORMATION.—Educational material under paragraph (1), and all other relevant educational and prevention materials prepared and printed from this date forward for the public and health care providers by the Secretary (including materials prepared through the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration), or by contractors, grantees, or subgrantees thereof, that are specifically designed to address STDs including HPV shall contain medically accurate information regarding the effectiveness or lack of effectiveness of condoms in preventing the STD the materials are designed to address. Such requirement only applies to materials mass produced for the public and health care providers, and not to routine communications.
(b) LABELING OF CONDOMS.—The Secretary of Health and Human Services shall reexamine existing condom labels that are authorized pursuant to the Federal Food, Drug, and Cosmetic Act determine whether the labels are medically accurate regarding overall effectiveness or lack of effectiveness of condoms in preventing sexually transmitted diseases, including HPV. [emphasis added]

The FDA is now doing its part to comply with this requirement by drafting new labeling requirements for condoms. As bad as the legalese is in the Federal Register announcement of the new rules, the document includes an extensive analysis of the current state of research on condom effectiveness and is worth a read by any who are concerned about the ongoing War on Condoms. As near as I can tell, however, the FDA is basically saying, "Duh! A barrier protects what it covers. What it doesn't cover, not so much."

Here is a summary of what the FDA is recommending regarding new labeling for condoms:

The labeling recommendations in the draft guidance are intended to provide information to users of latex condoms with and without spermicidal lubricant. The draft special controls guidance recommends labeling to inform users about the extent of protection provided by condoms against unintended pregnancy and against various types of STDs, as well as information about possible risks associated with exposure to N-9 contained in the spermicidal lubricant of some condoms. The labeling recommendations provide important information for condom users to assist them in determining whether latex condoms are appropriate for their needs and, if so, to determine whether a condom with or without N-9 lubricant is most suitable. Many of the labeling recommendations are similar to statements in existing condom labeling, but are being updated to reflect current information. The labeling recommendations related to N-9 are more comprehensive than existing labeling.

An interesting aside comes when the FDA notes what it will not recommend for the new labels:

The guidance for condom labeling does not recommend including information about other ways to prevent the transmission of STDs or to reduce the adverse clinical outcomes associated with these infections. There is important additional public health information about strategies to prevent transmission of HPV and to reduce serious clinical outcomes. These strategies include abstinence for men and women and regular cervical screening for women. However, the agency believes its primary role in this area is its jurisdiction over labeling for latex condoms and that its main goal must be to ensure that such labeling supports the safe and effective use of latex condoms by users who have chosen latex condoms for protection. At this time, the agency has concluded that it would not be useful to include in condom labeling additional educational information about social behaviors or public health programs that can reduce the risk and consequences of STD transmission. Additional information in condom labeling may confuse condom purchasers or cause them to overlook important messages. However, providing this information through other mechanisms not under FDA's jurisdiction may be beneficial.

No comments: