FDA approves new 5-day emergency contraceptive

Wilson School professor James Trussell, the director of the University’s Office of Population Research and a visiting professor at Hull York Medical School, helped to monitor several effectiveness trials on the new pill, called ella, as an unpaid consultant for HRA Pharma, the drug’s manufacturer.

The new pill’s main competitor, Plan B, is effective for up to three days after sex. Plan B is available without a prescription to women aged 17 or older, while ella requires a prescription in all cases.

Though ella should become available in the United States by the end of the year, it is unclear whether University Health Services will offer the new option to women on campus. UHS already offers Plan B.

“We would need pricing information before deciding if the medication could become available through UHS, or if UHS clinicians would provide prescriptions for students to get filled at a local pharmacy,” John Kolligian, executive director of UHS, said in an e-mail.

UHS reduced its subsidies for contraceptives in April when the University cut “discretionary funding” at UHS.

Meanwhile, UHS has already begun spreading awareness about ella by training its students in the peer-advising Sexual Health Advisors program. Irfan Kherani ’11, president of SHA, said he was introduced to the pill by a member of SHA during adviser training this past year and received further education from UHS nurse practitioners.

Both Kolligian and Kherani stressed that ella should not be relied upon for routine use as contraception and that the effectiveness of emergency contraception decreases as time passes after sex.

“As students and as peers, we are still advising students not to depend on any sort of rule that this emergency contraception will work for five days,” Kherani said. “We always recommend, regardless of the situation, that if you’re going to use emergency contraception, you take it as soon and as quickly as possible.”

Ella functions by blocking the effects of progesterone, a hormone that causes ovulation. It has drawn criticism from some anti-abortion activists because it is chemically similar to the abortion pill RU-486.

“To the extent that we do take issue with ella’s availability, it is the use of an abortifacent — that is, a drug that expels an implanted embryo or prevents embryonic implantation — as ‘contraception,’ ” Addie Darling ’12, vice president of Princeton Pro-Life, said in an e-mail. “It needlessly clouds the debate on abortion to begin to conflate abortive and contraceptive measures.”

Trussell discounted claims that routine use of ella could cause an abortion. There has been some evidence that ella makes the womb less hospitable to a fertilized egg, but not that it causes an abortion.

“If you’re going to ask me how many pills you would need to take to cause an abortion, that question has never been studied but the answer is certainly a lot,” Trussell said. “And therefore it would become quite impractical — where would you get all these drugs?”

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Yet even as ella’s longer period of effectiveness has drawn significant attention to the new drug — both positive and negative — HRA Pharma cannot advertise that the drug is effective for five days or that it is a better product compared to Plan B because of the nature of the trials that supported its approval.

The drug’s maker funded “non-inferiority trials,” which aim to show that a drug is no worse than one that is already available, rather than trials to show that the drug is better than others currently available, Trussell said.

Superiority trials are more expensive and they require a higher number of test subjects.

European regulators, who approved ella last year, do allow the drug to be marketed as effective for longer than Plan B.

Trussell said he believes that due to these restrictions in the United States, approval of the drug could have an “isolated effect,” with uptake limited to smaller pockets. He said that Princeton’s campus could end up being one such area.