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Morning after pill controversy heats up

Robin Wulffson MD's picture
morning after pill, emergency contraception, Plan B One Step, levonorgestrel

WASHINGTON, DC—On December 13, a federal judge rejected a request to hold the Food and Drug Administration (FDA) in contempt of court over its policy on the morning after pill: Plan B One Step. However, U.S. District Judge Edward R. Korman said he would consider reviewing the government’s refusal to make it easier for girls and women to get the drug. The judge agreed with the government that the request to hold the FDA in contempt was “moot” because the agency had reviewed a petition by family planning groups to make the morning after pill available without a prescription and had concluded on December 12 that there was insufficient evidence to do so.

Despite the foregoing, Judge Korman said he was willing to hear arguments over whether the FDA should have allowed the sale of the morning-after pill to girls younger than 17 without a prescription. Furthermore, he instructed advocacy groups to file the appropriate legal motions and specifically suggested adding Kathleen Sebelius, the Health and Human Services Secretary, to the lawsuit.

The Center for Reproductive Rights, which is leading the court challenge, noted that it would comply with the judge’s request. The center’s CEO, Nancy Northup, said “This fight is far from over. We intend to take every legal step necessary to hold the FDA and this administration accountable for its extraordinary actions to block women from safe, effective emergency contraception.” When asked about the judge’s decision, FDA spokeswoman Erica Jefferson said, “This matter remains under consideration by Judge Korman, therefore FDA has no comment.”

The legal posturing marks the latest development in the long, contentious battle over the morning after pill. Last week, the Obama administration shocked many women’s health advocacy groups by rejecting a request to make Plan B One-Step available to anyone without a prescription. At present, the morning after pill is available to individuals aged 17 and older without a prescription. Furthermore, they must furnish proof of age.

Also on December 13, Democratic senators, led by Senator Patty Murray (D-Wash.) entered the fray. They asked Secretary Sebelius to explain the rationale behind her decision, which had enraged many members of Congress and women’s health advocates.

"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:

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• 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).

• 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.

See Also:
Commissioner Sebelius nixes sale of morning after pill without ID
Obama backs Sebelius’ decision to limit sale of morning after pill