FDA Committee Agrees Ella is Safe and Effective

Jodi Jacobson

An advisory committee of the Food and Drug Administration has found that a new emergency contraceptive is safe and effective, and labeling should not restrict access to product.

This afternoon, the Advisory Committee for Reproductive Health Drugs of the Food and Drug Administration confirmed that, based on the evidence, a new emergency contraceptive method, known as ella, is safe and effective at pregnancy prevention up to 120 hours after unprotected sex or contraceptive failure.

The committee also recommended that labeling not restrict access to the method.

In a statement, Planned Parenthood Federation of America (PPFA) applauded the committee’s vote.

According to PPFA:

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The full FDA approval of UPA, a medication that can be used safely and effectively up to five days after unprotected intercourse, would provide women with more options to prevent unplanned pregnancies. This promising new emergency contraception, which, if approved, will be sold under the brand name “ella,” is already being used in Europe by women to prevent pregnancy up to five days after unprotected intercourse.

“Today’s vote by the FDA advisory committee that ella is safe and effective as a form of emergency contraception is a commonsense recommendation made by scientific experts,” said Cecile Richards, president of PPFA. “There are many reasons why a woman may face the risk of unintended pregnancy — from failure or improper use of birth control, to sexual assault — and every woman deserves every option available to prevent an unplanned pregnancy.”

At Planned Parenthood, doctors, nurses and clinicians encourage women and men to consider their health and lifestyle factors when determining which contraceptive method is best for them and their partners.  We know that birth control is most effective when women and men make informed decisions and get the contraceptive method that is most appropriate for them,” said PPFA Vice President of Medical Affairs, Dr. Vanessa Cullins.

“We want all of our patients to have as many safe and effective options to chose from as possible when they are either trying to prevent pregnancy over the long term or in emergency situations.” 

Ella, or UPA, is safe and effective at preventing ovulation and therefore pregnancy in the five days after unprotected intercourse,” added Cullins. “Given the fact that half of all pregnancies in the U.S. are unintended, it is vital that women have an array of choices available to prevent unplanned pregnancy. Ella will become an important option for women.”

Kirsten Moore, President and CEO of the Reproductive Health Technologies Project, stated:

“We appreciate the committee’s unanimous consensus that labeling should not contain restrictions on access to the product. The ball is now in FDA’s court to quickly complete their review and approve this safe and effective product that gives women a chance to prevent unintended pregnancy.”

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