Friday, November 11, 2005

The Story Behind Proposed Changes to Condom Labels

When I first read the news about the FDA's proposed draft guidelines for male latex condoms something didn't sound right to me.

New draft guidelines for male latex condoms published on Thursday call for packaging to include information they reduce, but do not eliminate, the risk of pregnancy and sexually transmitted diseases.

The U.S. Food and Drug Administration guidelines also specifically say condoms that contain the spermicide nonoxynol-9 must specify that they can cause irritation and increase the risk of HIV, the virus that causes AIDS.

They also specify that consistent condom use may help protect against some other sexually transmitted diseases, such as human papilloma virus, or HPV, that are transmitted through skin contact.

The article makes it sound like condom labels lack information about the risk of pregnancy and the degree of protection from sexually transmitted diseases (or lack thereof). Not true. The information is already included in the packaging. Also, proposed FDA guidelines for labeling warnings about nonoxynol-9 (N-9) date back to 2003; they were issued shortly after the 2002 CDC guidelines.

A short excerpt from the CDC:

Recent studies have found that frequent use of N-9, a spermicide contraceptive, can cause genital lesions (in the vagina) and, therefore, may increase the risk of HIV transmission. It has also been found to cause damage to the lining of the rectum, providing an entry point for HIV and other STDs. According to the guidelines, spermicides -- especially those that contain N-9 -- should not be used for STD prevention. Furthermore, N-9 lubricants should not be used during anal intercourse.

While the level of N-9 used as a lubricant in condoms is much lower than the level found to be harmful, condoms lubricated with N-9 spermicide also are not recommended because they have a shorter shelf life, cost more and have been associated with urinary tract infections in women. However, previously purchased condoms with N-9 can be used, provided they have not passed their expiration date, since the protection provided by the condom against HIV outweighs the potential risk of N-9.

Returning to the new draft guidelines, another area affected by the labeling changes would be that of proper condom use:

The draft labels, required by law, also address incorrect or inconsistent use, saying condoms should be thrown away -- not flipped over -- if not unrolled correctly.

But, again, condom labels already contain this information. According to current FDA requirements for condom labeling:

Latex condoms must also include adequate directions for use to avoid being misbranded (section 502(f) of the Act, 21 U.S.C. 352(f); 21 CFR section 801.5)....The following set of statements is an example of acceptable directions for use for latex condoms:

  • If the condom doesn't unroll, the wrong side was placed against the penis. Do not flip over. Throw it away and start over with a new condom.

  • So far it's not clear what is behind these FDA proposed draft guidelines for condom labels. [Possibly a desire to refine some of the language about N-9? But, according to the FDA draft, the guidelines would apply to latex condoms, with or without N-9. And why bury the N-9 language in so much redundant information?]

    The article continues:

    Congress called for the new FDA proposal to ensure condom labels were "medically accurate," but there has been debate between lawmakers and FDA scientists about what should be included.

    Pardon my poor reading comprehension skills, but does this say that Congress asked the FDA to issue a proposal, or does it say that, once the FDA issued it, Congress called for it to be medically accurate? And why on earth is the FDA debating medical accuracy with politicians? Medical guidelines are not some pork-laden bill, to be arrived at through negotiation and compromise. FDA's action doesn't make much sense.

    "The new guidance for condom labels issued today by the FDA recognizes that current condom claims do not meet this medical standard," said Sen. Tom Coburn, an Oklahoma Republican and physician who has pressed for the changes.

    Coburn said he welcomed the new nonoxynol-9 warning but rejected the claims about HPV, a virus that can cause cervical cancer. "The agency continues to promote inconclusive assurances that put women unknowingly at risk for cervical cancer, or worse," he said.

    Really: N-9 warning--good, HPV protection claims--bad? Did Sen. Coburn look deeply into the FDA's eyes (or maybe he viewed a tape) and divine that the agency is deliberately placing women at risk for HPV-related diseases? Because the medical literature doesn't support his statement.

    Briefly, from the review studies. No conclusive evidence that N-9 use increases your risk of HIV infection. Consistent evidence that genital lesions are more common in N-9 users. [These lesions are potential portals of entry for the HIV virus.] Conclusive evidence that condom use reduces the risk of HPV-related diseases (genital warts, precancerous lesions, etc.). No consistent evidence it prevents HPV infection.

    Thus, the following language from the FDA guidelines

    Using a condom also may lower your risk of developing HPV-related diseases, such as genital warts and cervical cancer....N-9 can irritate the vagina. This may increase the risk of getting HIV/AIDS from an infected partner.

    accurately reflects the available scientific evidence. In contrast, Sen. Coburn's statement reflects crass ideology. [In my opinion, a serious transgression for a physician.]

    Long story short, in order to figure out what is really going on with the proposed FDA guidelines, I had to go googling for the actual draft. [Curiously, this is not an easy document to locate.] Here it is, in all its glory (.pdf). [And may I just say "Ha!"; my instincts were correct.]

    From the Introduction (emphasis mine):

    This draft guidance will be issued in conjunction with a Federal Register notice announcing the proposal to amend the two existing classifications for condoms from class II (performance standards) to class II (special controls)....If a final rule to amend the classification for condoms is not issued, the final guidance document will not be issued.

    So much for the intrinsic value of the new label changes.

    Bottom line: The story isn't that the FDA is proposing changes to condom labels. It's that there is a (possibly politically instigated) push to reclassify condoms from performance standards devices to special controls devices.

    Anyone who really believed that a politically negotiated (mandated?) FDA action would have anything to do with science, as opposed to, you know, an attempt to exert even more control over our lives and medical decisions, raise your hand.

    Update: Welcome Pandagon readers!


    At 5:47 PM, Blogger Andrea said...

    Don't get too up in arms about Congress mandating FDA actions. It's already clear that at this point the FDA is a political puppet. Besides, there's another bill in Congress now that would require OTC sales of Plan B within 30 days if the FDA doesn't take action on approval of Plan B.

    That bill definitely makes me happy :)

    At 9:59 PM, Anonymous Anonymous said...

    What do those categories mean, in layman terms?

    At 6:52 AM, Anonymous Anonymous said...

    I second HW's question.

    A condom does seem like the sort of thing I'd call a "special control" rather than a "performance standard" if it was just a word choice issue, but there's probably something more important at work involving legal definitions, which you're assuming we've picked up on but nobody really understands

    At 4:11 PM, Blogger ema said...

    Briefly, the categories have to do with the degree of FDA regulation. Up to now, condom manufacturers, in order to be able to sell their product, had to show that the product was up to a certain set of "performance" standards (composition, strength, integrity, etc.). For condoms there are additional requirements: general controls (good manufacturing practices), registration and listing, adverse event reporting, etc. Also condoms have general and specific labeling requirements (expiration date, latex sensitivity warning, etc.). [All this is Class II "performance standards" device.] When you reclassify a device, to a Class II "special controls" device in our case, you introduce new regulatory requirements. So, now, unless the manufacturer can show that their product complies with whatever "special controls" the FDA decides to impose, they won't be able to sell the device:

    We propose that latex condoms cleared for marketing on or after this effective date (but submitted in 510(k)s filed before the effective date) comply with the requirement of special controls by following the recommendations in the special control or providing equivalent assurances of safety and effectiveness no more than 60 days after the effective date of any final rule based on this proposal. Premarket notification submissions (510(k)s) for new latex condoms with or without spermicidal lubricant, filed after the effective date of any final rule based on this proposal, must address the issues covered in the special controls guidance document when the 510(k) is submitted.

    Here is a more detailed explanation (sorry, I wasn't able to find anything less technical.)

    At 4:46 PM, Blogger ema said...

    I forgot to point out something. In the document I linked above the FDA does offer its side of the story, so to speak. In all fairness, you should be aware of it (scroll down to ~the lower 1/3 of the document page; it's under the heading of "Other options the agency considered."):

    One option the agency considered was to publish its conclusions as a regular guidance
    document, rather than as a special controls guidance document. This approach would have made the information available to the public through agency publication, but it would not have required that manufacturers address the labeling issues FDA has identified....
    The agency also considered rulemaking that would mandate specific new language on all condom labeling to address the concerns FDA has identified. The agency rejected this option because a labeling rule deprives manufacturers of any flexibility with respect to the way they provide the information to consumers and because a labeling rule is
    difficult to change or amend as new scientific information becomes available to update the public health message.
    The benefit of the option the agency has chosen is that establishing the labeling guidance as a special control means that manufacturers will be required to address the concerns identified in the guidance, although they will not be bound to use the particular language FDA is recommending.

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