The Pill Is Next

If you thought the FDA's recent decision not to approve OTC status for Plan B was dubious, brace yourself. There's more to come.

The FDA is hard at work on a "nonbinding" final guidance on proposed OCPs (oral contraceptive pills, or birth control pills) labeling changes.

Proposed labeling changes, which many industry leaders call overly restrictive and lacking in important information about health benefits associated with OC use, were initially distributed in July of [2000]. They were revised based on industry feedback and redistributed this year.

Do you think the feedback helped?

The revisions are misguided, said Dr. Philip Corfman, a gynecologist and reproductive health care consultant who previously was a medical officer with the FDA. He noted that the recommendation to exclude the prevention of endometrial and ovarian cancer as a potential benefit of OC use is particularly egregious, given the ample evidence for this benefit.

Women who use OCPs have a 40% reduction in the risk of developing ovarian cancer, and a 50% reduction in the risk of developing uterine cancer. But wait, there's more. For both cancers, the protection begins within one year of use, and lasts for at least 30 years (for ovarian cancer) and ~15 to 20 years (for uterine cancer) after the woman stops using OCPs.

Here are some of the other problems with the FDA's proposed guidance, as noted by Dr. Cullins (vice president for medical affairs at Planned Parenthood Federation of America):

- The linking of the need for an annual history and physical with the prescription of OCs. (The lack of an immediate exam should not preclude an OC prescription, she said.)

- The lack of thorough information about contraceptive-method failure rates, specifically information that distinguishes between failure rates in those who do not use OCs consistently and/or correctly from failure rates in those who do.

- The recommendation that nursing mothers use another form of contraception until the child is weaned, which is not in keeping with recent data that suggest combined OCs are safe after the 6th postpartum week in nursing mothers.

Great disservice to the health of American women: check.

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