Expanding emergency contraception options

Repro rights
By DEIRDRE FULTON  |  July 1, 2010

A new "morning-after pill" is on the verge of being approved for prescription use in the United States; this one could be safely and effectively taken for five mornings after unprotected sex.

The manufacturer, the Paris-headquartered HRA Pharma, calls ulipristal acetate a "next-generation emergency contraceptive" that "prevents more pregnancies than a widely-used alternative" — Plan B, the emergency contraceptive sold over the counter to women over the age of 17 at drugstores throughout America. Plan B is known to work for up to five days — but its efficacy decreases after 72 hours. An HRA Pharma-funded study published in the medical journal The Lancet and another article in Obstetrics & Gynecology claim that ulipristal maintains its efficacy throughout the five-day period after unprotected sex or contraceptive failure (i.e., a broken condom).

For sale in more than 20 European countries under the name "EllaOne" (just plain "Ella" is the proposed trademark for use in the US), ulipristal acetate works by delaying ovulation (releasing of the egg). According to a Planned Parenthood fact sheet, this chemical compound is more effective than progestin-only EC (like Plan B) at preventing "imminent ovulation" during "a woman's fertile period."

Steve Trombley, CEO of Planned Parenthood Northern New England, calls Ella "a promising development" in reproductive-health medicine, one that increases options for women and their doctors. Currently, the only other option for women at the tail-end of the five-day window is the insertion of a copper IUD into the uterus, which is rather more involved than writing and filling a prescription.

On June 17, the US Food and Drug Administration (FDA) Advisory Committee for Reproductive Health Drugs voted 11-0 to recommend approval for sale in the United States. The full FDA is expected to make a decision on Ella by the end of July. While the manufacturer would have to make a separate request for over-the-counter status, observers are fairly certain that Ella will get FDA approval for prescription use.

"We are optimistic about the prospects of providing US women with a new emergency contraceptive option," says Fred Wilkinson, executive vice president of Watson Pharmaceuticals, the New Jersey-based company that will be responsible for selling and marketing Ella in the United States.

Unsurprisingly, the United States Conference of Catholic Bishops voiced "grave concern" about Ella, saying that it is "more similar in effect" to the abortion drug RU-486 (which is a different chemical compound entirely — mifepristone).

"Ulipristal is a close analogue to the abortion drug RU-486, with the same biological effect," wrote Cardinal Daniel NiNardo, chairman of the USCCB's committee on pro-life actions, in a letter to the FDA opposing approval. "That is, it can disrupt an established pregnancy weeks after conception has taken place."

But these objections are merely another attempt by pro-life activists to confuse abortion and contraception: medical experts say Ella is so effective at blocking ovulation that the drug would rarely interact with a fertilized egg. And the indicated dosage is too low to prevent implantation of a fertilized egg.

"People who are opposed to abortion have long been opposed to contraception," Trombley says. "We're all entitled to our own opinions in this debate; we're not entitled to our own facts."

  Topics: This Just In , Politics, sex, emergency contraception
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