Video: Panel backs 5-day 'morning after' pill

  1. Transcript of: Panel backs 5-day 'morning after' pill

    LESTER HOLT, anchor: We're back now with news about women's health and a new form of oral contraception that got the go ahead today from a government advisory panel. It's called Ella One , and it's already approved in 22 other countries. Today's decision isn't the final word, but it does move this new pill a big step closer to market here in the US. Our chief medical editor Dr. Nancy Snyderman is here now with details. Dr. Snyderman:

    Dr. NANCY SNYDERMAN reporting: Lester , in a unanimous vote, a panel of reproductive health experts deemed Ella One safe and effective for preventing pregnancy after a woman has unprotected sex . Now, there's a similar type of contraception called Plan B that's currently available in the United States , but it must be taken within three days after sex. And this new contraceptive not only lengthens that window, but it also reduces the chance of pregnancy for up to five days after sex. The pill is currently approved and sold in 22 countries and it is known as Ella One . While the FDA is not required to take the advice, as you said, of this advisory panel, it usually does so. And if it is expected to be approved and it does come to the United States , it will be marketed and sold under the name Ella .

    HOLT: And so what happens next, Nancy ?

    SNYDERMAN: Well, Lester , now the politicking begins because this is a close chemical cousin to the morning after pill RU-486 . And some abortion opponents will likely argue that this is nothing more than an abortion pill ; others may say that there's not enough testing been done. But so far, if you look at the track record in Europe , it looks pretty good. And so I think this -- the argument will be, `Let's let the science play out.'

updated 6/17/2010 5:10:11 PM ET 2010-06-17T21:10:11

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.

Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


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