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Commissioner Sebelius nixes sale of morning after pill without ID

Robin Wulffson MD's picture
Plan B One-Step, levonorgestrel, morning after pill, Kathleen Sibelius

Plan B One-Step is an emergency “morning after” contraceptive that prevents a pregnancy if taken within 72 hours of having unprotected intercourse. The drug’s manufacturer, Teva Pharmaceuticals had petitioned the Food and Drug Administration (FDA) to allow merchandisers to place the morning after pill on shelves with other family-planning products - and to sell it to anyone who wanted it. The manufacturer claimed that it had conducted a study, which revealed that girls as young as 12 could understand how to safely use the product.

The FDA agreed; in a statement released December 7, FDA Commissioner Margaret Hamburg, MD, said "there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of childbearing potential." However, in a surprising move, Health and Human Services (HHS) Commissioner Kathleen Sebelius, Dr. Hamburg's boss, overruled the FDA.

Sebelius claimed tha only about 10% of girls are able to get pregnant at age 11. In a statement, Commissioner Sebelius said her action "reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger without talking to a healthcare professional."
The studies submitted to FDA, as published, included girls aged 12 to 17. The study reported that at least 79% of the youngest girls could understand the instructions. Administration of the single-dose pill must be taken within 72 hours of unprotected sex; thus, if a prescription is required that time limit is likely to be exceeded before a girl can obtain one.

"The sooner Plan B is taken, the better it works," said Amy Niemann, vice president of Teva Women's Health. She added, "That is the entire rationale for having widespread availability for this product." Nancy L. Stanwood, MD, MPH, section chief of family planning at Yale School of Medicine, noted that full over-the-counter (OTC) status would have made emergency contraception available to many more people who need it. She noted, “The irony of Plan B not being OTC for women of all ages is that it has not been available for the women who need it the most… "Teens may be sexually active for a while before they see a doctor to get a prescription for contraceptives. ... [With emergency contraceptives] they don't just have to hope the condom doesn't break. There is something they can do."

Another group of women that may be in need of the morning after pills are rape victims. Dr. Stanwood said, "Many women who have been raped do not come in for medical care, and many do not see a doctor in a timely manner… With over-the-counter sale of Plan B, at least they could do this. And young women are more likely to be raped. We want these women to get medical care, but most do not do it quickly."

Plan B One-Step facts:

• Plan B should be taken within 72 hours (three days) of unprotected intercourse. When taken within 72 hours, it decreases the chance of getting pregnant by 89% (from 8% without Plan B to 1% with Plan B).

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• Plan B is even more effective when taken within 24 hours. Effectiveness decreases the longer a woman waits to take it.

• Plan B is not an abortion pill. It contains levonorgestrel, a synthetic version of the hormone progestin. The abortion pill RU-486 contains a completely different drug.

• Plan B works mainly by preventing release of eggs from a woman's ovary, although it may also prevent sperm from fertilizing the egg. However, if a fertilized egg already has been implanted, the pregnancy continues normally even if a woman takes Plan B.

• Plan B may cause side effects. The most common side effect is nausea, which occurs in about 25% of women after taking Plan B. Other side effects may include abdominal pain, fatigue, headache, and heavy menstrual bleeding.

• An older version of Plan B required a woman to take two pills 12 hours apart. The current Plan B One-Step formulation is a single pill taken only once, as soon as possible after unprotected intercourse but no longer than 72 hours later.

• Plan B is not the only emergency contraceptive. Ella, from HRA Pharma, is a different medication that prevents pregnancy when taken up to five days after intercourse. Ella is available only by prescription; HRA has not sought over-the-counter approval from FDA.

• Contrary to the fears of some, women and teens with access to Plan B or Ella do not use the drugs as a regular contraceptive, notes Dr. Stanwood. She adds that teens who can get these drugs do not have sex more than teens who cannot get them.

Source: HHS Commissioner Kathleen Sebelius statement