FDA Advisory Committee Recommends Approval of Ella
Yesterday, FDA's Advisory Committee for Reproductive Health Drugs voted unanimously that federal drug regulators should approve the French emergency contraceptive drug, Ella (ulipristal acetate).
Ella is manufactured by HRA Pharma, but was developed in the United States by Research Triangle Institute (RTI) under contract with the National Institute of Child Health and Human Development (NICHD). HRA Pharma took over the drug in 2000, then in 2002 signed a collaborative research and
development agreement with NICHD which was renewed in 2006.
Ella is a selective progesterone receptor modulator developed specifically as an emergency contraceptive. Ella will prevent pregnancy up to five days after having unprotected intercourse or in case of failure of contraceptive.
Currently in the United States, the emergency contraceptive available is Plan B pill, which is beneficial only up to 72 hours after sex. It is available for sale without a prescription for women older than 17.
If the FDA approves Ella, the United States will join 22 countries where the drug is already available. The drug Ella is seen as a much needed additional form of emergency contraception by many U.S. advocates for family planning and reproductive rights.
As with Plan B, Ella is receiving opposition from pro-life groups who view it as a form of abortion rather than contraception. These groups argue the drug Ella has a chemical similarity to RU-486 which makes it more like the controversial abortion pill, which can terminate a pregnancy at up to nine weeks.
The FDA usually follows the advice of its advisory panels but not always.
French Emergency Contraception Drug Ella to be Reviewed by FDA
Ulipristal Acetate Works Up to Five Days as "Morning After" Pill
Approval for Plan B Over-the-Counter Sales Victory for Women's Health