FDA proposes new labels for condoms

Conservatives urged wording on risks

November 11, 2005|By JONATHAN D. ROCKOFF | JONATHAN D. ROCKOFF,SUN REPORTER

WASHINGTON — Prompted by conservative lawmakers, the Food and Drug Administration is proposing that condom packages carry labels saying that condoms greatly reduce but don't entirely eliminate the risks of pregnancy and certain sexually transmitted diseases.

The agency acted after a Republican senator held up the appointment of an FDA commissioner until assured the issue would be addressed. Liberals complain that conservatives are trying to undermine safe sex practices.

Most labels say only that condoms reduce the chances of pregnancy or acquiring a sexually transmitted disease, such as HIV. The FDA, which doesn't require the labels but recommends wording, is proposing adding language and charts showing that condoms aren't completely effective at reducing the risks.

Sen. Tom Coburn, a Republican from Oklahoma who has been particularly vocal in calling for changes in condom labels, said yesterday that the proposal was an improvement, but did not go far enough.

"While the new guidance should ensure condom labels are more medically accurate by toning down the claims of protection, FDA still embraces some inconclusive and exaggerated claims of condom effectiveness," he said.

Coburn, a physician, has pressed for labels warning that condoms do not prevent transmission of human papilloma virus, which can cause cervical cancer. He said the FDA is endangering Americans by failing to include that information.

Rep. Mark Souder, an Indiana Republican, agreed and called the FDA recommendations "misleading" and "dangerous."

Liberal groups praised the FDA for sidestepping conservative efforts to promote abstinence. But they said the proposed rewording might confuse and perhaps alarm consumers.

"For sexually active people, condoms are the best things we've got, so you don't want to emphasize the problems with them," said Deborah Arindell, vice president for health policy at the American Social Health Association.

Marilyn Keefe, vice president of public policy at the National Family Planning and Reproductive Health Association, said wording about the human papilloma virus "fails to convey" that most women who are sexually active acquire the virus but naturally fend it off without developing cervical cancer.

"The FDA's guidance fails to make that clear and we are concerned that this lack of clarity might dissuade people from using condoms," she said.

In its proposal, the FDA will also recommend that condoms with the spermicide nonoxynol-9 carry a warning that use can increase the risk of getting HIV/AIDS from an infected partner. The agency also will recommend a warning that people with HIV/AIDS not use condoms with the spermicide.

In April, the Government Accountability Office issued a report criticizing the FDA for failing to publicize scientific evidence that N-9 doesn't protect against HIV.

Federal law directed the FDA to review condom labels five years ago. Coburn held up the confirmation of former FDA Commissioner Dr. Lester M. Crawford over the delay.

jonathan.rockoff@baltsun.com

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