A US health panel voted unanimously to allow the sale of a controversial French birth control pill, which can prevent pregnancy for up to five days after unprotected sex.
The final decision by the Food and Drug Administration (FDA) is not expected for several months, but the so-called morning-after pill "Ella" got the nod of approval by 11 medical experts on an FDA advisory panel who deemed it safe.
The move is likely to stir controversy from the anti-abortion movement, because of the way it works. The manufacturers, France's HRA Pharma laboratory, say it delays ovulation, while opponents maintain it works by stopping a fertilised egg from implanting in the walls of a woman's uterus.
"We are delighted the committee was able to confirm our product's effectiveness," top US executive Erin Gainer from HRA Pharma told AFP.
Green light for sales
"We're optimistic" Ella will get the FDA's green light for sale in the United States, she added. The panel's advice is not legally binding on the FDA, but it is usually followed.
HRA said it hopes to market Ella in the United States by the end of the year through its US partner Watson Pharmaceuticals. As in Europe, it would be sold by prescription on the US market. In the United States, it would be in competition with Plan B, already available over the counter here, and its generic version, Next Choice.
Is it abortion?
But the longer contraceptive period offered by Ella - five days as opposed to three days for Plan B - could raise controversy with anti-abortion groups who consider its effects more akin to abortion than birth control.
As a precaution, two police officers were posted at the hotel outside Washington where the public, medical debate over the new pill was held. There was no trouble.
Ella's chemical composition is also similar to the RU-486 abortion pill that prevents pregnancy for up to nine weeks after intercourse. Introduced 10 years ago in the United States, RU-486 raised the hackles of the anti-abortion crowd.
"The big elephant in the room is whether or not this medication is inducing some sort of abortion," said a member of the FDA panel. "This drug is not to be used if already pregnant," said Gainer from the manufacturers.
Ella's yearly sales in Europe reach 36.5 million euros and its US potential is "several hundred million dollars," according to Gainer.
Question over effectiveness
The FDA panel asked many questions about the drug's apparently reduced effectiveness in overweight women, and its side effects.
"The most common adverse reactions were nausea, headache, dysmenorrhea, abdominal pain, fatigue, and dizziness," the FDA advisory committee reported on the results of Ella's clinical trials with 4,700 women.
Several women's aid groups testified before the committee and largely backed the marketing of Ella in the United States.
"The US has one of the highest teen pregnancy rates in the developed world. We have more than six times the pregnancy rate of the Netherlands, almost four times that of Germany and almost three times that of France," Advocates for Youth manager Sarak Audelo told the panel in support of the French pill.
Concerned Women for America president Wendy Wright however compared Ella to the abortion pill RU-486 which she said has caused seven deaths since it was introduced in this country. "Ulipristal or Ella is similar to mifepristone (RU486) a drug that causes an abortion," she said.
"RU-486 was approved without adequate trials and even with restricted distribution has resulted in thousands of complications including deaths." - (Virginie Montet/Sapa, June 2010)