Emergency contraceptive proves controversial in US
pharmafile | August 16, 2010 | News story | Sales and Marketing | Ella, Plan B, Watson, emergency contraceptive
The FDA has approved HRA Pharma’s emergency contraceptive pill Ella but has been criticised by conservative ‘pro-life’ groups.
French company HRA Pharma has gained approval for Ella (ulipristal acetate) and is working with Watson Pharmaceuticals to launch the drug as a prescription-only medicine in the coming weeks.
The issue of abortion is hugely controversial and is traditionally divided along religious and political lines.
The first ever ‘morning after pill’ in the US, Teva’s Plan B, was launched in 2006, despite huge opposition from pro-life groups. After further legal wrangling, Plan B was approved as an over-the-counter product for over 17s last year.
HRA already markets its product in Euroe, where it is known as EllaOne.
The drug prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. This is longer than the three day window in which Plan B can be taken, which could give Ella a competitive edge, despite its prescription-only status.
Erin Gainer, chief executive of HRA Pharma, said: “As a pioneer and a leader in the field of emergency contraception, HRA Pharma is committed to providing women and their health care providers highly effective contraceptive options.”
“Ella, an effective and well-tolerated new generation emergency contraceptive, fulfills a significant and previously unmet need in this field by reducing pregnancy risk up to five days after intercourse.”
The safety and efficacy of Ella were demonstrated in two phase III clinical trials. One study was a prospective, multi-centre, open-label, single-arm trial conducted in the US; the other was a randomised, multi-centre, single-blind comparator-controlled trial conducted in the US, UK and Ireland.
Its active ingredient is a synthetic selective progesterone receptor modulator and it is the first molecule to have been specifically designed and developed for use as an oral emergency contraceptive.
Criticism
Despite a unanimous decision to approve the drug by the FDA this month, a number of pro-life groups have come out against Ella.
Jeanne Monahan, director of the centre for human dignity at the US Family Research Council (FRC) has said that the FDA were “misleading” in calling this drug an‘emergency contraceptive’, and said it should be labelled as an abortion drug.
Monahan said: “The FDA opted against including the critical fact that Ella can cause an abortion on a baby already implanted in its mother’s womb in the drug labelling information.
Ben Adams
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