FDA panel unanimously backs safety and effectiveness of new morning after contraceptive

FDA panel backs new emergency contraceptive

WASHINGTON — Federal health experts said Thursday a new type of morning-after contraceptive that works longer than existing drugs is safe and effective.

The Food and Drug Administration’s panel of reproductive health experts voted unanimously that the pill ellaOne successfully reduces the chance of pregnancy up to five days after sex. Plan B, the most widely used emergency contraceptive pill, is only effective if women take it within three days of sex.

In a separate vote the panel unanimously ruled that the drug appeared safe, according to an FDA spokeswoman.

The positive recommendation moves the pill, which is already approved in Europe, one step closer to the U.S. market. The FDA is not required to follow the panel’s advice, though it often does.

Studies by the drug’s manufacturer, HRA Pharma, showed ellaOne prevented pregnancies longer and more consistently than Plan B.

In a head-to-head trial between the two drugs, women who took ellaOne had a 1.8 percent chance of becoming pregnant, while women who took Plan B had a 2.6 percent chance.

Experts tracked nearly 1,700 women who received emergency contraception within three to five days of having unprotected sex.

Plan B is made by Teva Pharmaceuticals and also marketed in generic versions by Watson Pharmaceuticals among other companies.

Privately held HRA Pharma is based in Paris and specializes in women’s health products.

EllaOne has drawn criticism from anti-abortion groups who argue the drug is closer to an abortion pill than emergency contraception. Groups presenting at the meeting said the drug is chemically similar to the abortion drug Mifeprex, which can be taken to end a pregnancy up to 50 days into the gestation period.

That drug has been associated with severe infections and bleeding after abortion. However, FDA reviewers found no major medical side effects with ellaOne.

HRA is only seeking FDA permission to sell its drug with a prescription. Plan B and generic versions are available without a prescription for women 17 years old and older.

HRA scientists told the FDA panelists that additional options for emergency contraception are needed to reduce unplanned pregnancies.

The FDA is scheduled to make a decision on ellaOne by late July.