Friday, June 15, 2007

The FDA Cockblocks America, Again

This utterly fucking shocking announcement from the FDA needs no explanation. Except, of course, that the only reason anyone is confused about condom effectiveness rates is because religious conservatives claim that condoms are far less effective than the FDA itself. Read the article. (Emphasis mine)

Condom packaging may change to point out limits

Bloomberg News, New York, 6/15/07

The FDA is planning a survey to evaluate the effectiveness of current condom packaging and possibly to impose new packaging requirements.

Condom packaging may be redesigned to emphasize the devices' limits in preventing pregnancy and sexually transmitted diseases such as AIDS, U.S. regulators said.

The Food and Drug Administration plans to survey 1,200 people in shopping malls about how well they understand condoms' effectiveness based on the current labeling and proposed new precautions, the agency said in a notice posted today on its Web site. Responses will help regulators draft new labels that all packages of latex condoms would have to carry.

The regulatory agency has been drawn into a long-running dispute between makers of condoms and religious groups that say people are misled about how well the products work as an alternative to abstinence and monogamy. Manufacturers include Church & Dwight Co., maker of Trojans, and SSL International Plc, producer of the Durex brand.

The survey "will be considered in FDA's condom labeling recommendations to provide important risk/benefit and use information associated with condoms in easily understood language," according to the agency's notice.

Congress directed the FDA in 2000 to "determine whether the labels are medically accurate regarding the overall effectiveness or lack of effectiveness." The agency proposed in 2005 that condom boxes and wrappers should show data on unintended pregnancies and varying levels of protection against sexually transmitted diseases so that consumers can make informed decisions about their sexual behavior.

The changes would apply only to male condoms made with natural rubber latex, which account for almost 98 percent of U.S. sales, the FDA said.

Market Share

Church & Dwight Co., based in Princeton, New Jersey, controls about 73 percent of the market, according to its annual report. SSL International Plc, based in London, and Ansell Ltd, the Australian maker of LifeStyles condoms, are its biggest competitors.

Regulators said they plan to issue guidelines for products made with lambskin or synthetic materials at a later date.

Latex condoms have been used for almost 100 years to guard against pregnancy and more recently have been promoted as protection against AIDS, genital herpes and other sexually transmitted diseases.

Religious groups oppose advocacy of "safe sex" using condoms.

Catholic Bishops

"This is poor and inadequate advice, given the failure rate of prophylactics and the high risk that an infected person who relies on them will eventually transmit" AIDS from doing so, said the United States Conference of Catholic Bishops in a statement on AIDS approved in 1989.

The FDA, in its 2005 review, found that many people who use condoms aren't aware of how often they fail to prevent pregnancy with typical use, or that they provide less protection from certain STDs, such as genital herpes, that can be transmitted by contact with skin not covered by a condom.

The agency suggested that all boxes of condoms and individual wrappers clearly state that the products "greatly reduce, but do not eliminate" the risk of pregnancy and STDs. The FDA also recommended that condoms with the spermicidal lubricant nonoxynol-9 carry a warning that the lubricant can cause irritation that increases the risk of HIV/AIDS transmission.

1 comment:

meredith said...

let's hope that the FDA takes the recommendations borne out of this survey as seriously as they originally took the recommendations of all the professional medical associations on EC. in other words, with total disregard.