The USA's Health and Human Services Secretary Kathleen Sebelius has over-ruled a Federal Drugs Administration (FDA) decision to allow the sale of a controversial drug from pharmacies and without the intervention of medical care.
The FDA, in the face of much criticism, decided to authorise the over-the-counter sale of Plan B One-Step, described as "an emergency contraceptive" in the past few days. But Sebelius overturned the decision in a move believed to be unprecedented in the FDA approvals process.
The FDA approved the sale of the drug to women and girls aged 17 and over. It is a one-time tablet that the manufacturer, Teva Pharmaceuticals, markets under the slogan "Every hour counts" and emphasises in its website "the sooner you take it, the better it works."
Based on the drug Levonorgestrel, Plan B One-Step "Plan B One-Step® isn't effective if you're already pregnant, and it won't terminate an existing pregnancy," according to the makers. It says that it is for use in the case of "known or suspected contraceptive failure or unprotected intercourse." And it says that it is effective for up to 72 hours after the event, but that effectiveness decreases over that timeframe.
But the company says that it "should not be used as routine birth control, as it isn’t as effective." It works by preventing fertilisation and, depending on the timing, ovulation. Because only fertilised eggs implant into the wall of the uterus, no egg or no fertilised egg means no pregnancy.
"It is common knowledge that there are significant cognitive and behavioural differences between older adolescent girls and the youngest girls of reproductive age," Sebelius said. "I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age."
In short, despite the warnings, Sebelius considers that it will increase promiscuity and the risk of sexually transmitted diseases amongst the young.
Libertarian women's health groups have expressed "outrage" at the decision.
Supporters of the decision argue that, when teenagers are browsing for condoms and creams that the presence of an "easy option" on the shelves will prove attractive. Some also appear to consider that ease of access might lead to sexually active younger children shoplifting the drug.
There remains heated debate about the availability alternative drugs which induce early abortion.
eZ publish™ copyright © 1999-2012 eZ systems as