"The abortion pill is safe, effective and legal. So why is the FDA keeping it locked away from women who need it?" said Julia Kaye, an attorney with the ACLU Reproductive Freedom Project. "The FDA's unique restrictions on medication abortion are not grounded in science — this is just abortion stigma made law."
The restrictions have been in place since the drug was approved for use in the U.S. in 2000. They stipulate that Mifeprex may not be sold in pharmacies and that all providers of the drug undergo a special certification process.
The Abortion Pill is Safe, Effective and Legal. So Why is The FDA Keeping it Locked Away
The FDA issued new guidelines for the use of Mifeprex last year, and said at the time that the restrictions continue to be necessary to ensure safe use of the drug.
The FDA confirmed this week that the agency's position has not changed since then. Regarding the lawsuit, it said the agency does not comment on pending or ongoing litigation.
The suit was filed on behalf of three health care associations and a physician, Graham Chelius. He works on the Hawaiian island of Kauai, which currently has no abortion providers.
Chelius, a family medicine doctor, says he is qualified and willing to provide medication abortion, but is unable to stock the abortion pill at the hospital where he works because of objections from some colleagues. As a result, he says, his patients must carry an unwanted pregnancy to term or make a 300-mile round trip flight to another island to get an abortion — boosting costs and sometimes delaying the procedure by several weeks. This could be avoided if the pill were available at pharmacies on Kauai.
The lawsuit is supported by the American Congress of Obstetricians and Gynecologists. Its CEO, Dr. Hal Lawrence, said there is no medical justification for the FDA restrictions.
According to a commentary earlier this year in the New England Journal of Medicine, 19 deaths have been reported to the FDA among the more than 3 million women who have used Mifeprex in the U.S. since 2000, a mortality rate lower than for pregnancy-related deaths among women.
The commentary suggested that lifting the FDA restrictions would likely increase the number of doctors willing to prescribe Mifeprex, since they would no longer have to stock the drug in their office and no longer have to be on a list of certified abortion providers. Easing the rules also might help make medical abortion more available via telemedicine to women in rural areas who live far from the nearest abortion facility, said the 10 co-authors, who included doctors and academics from Stanford, Princeton and Columbia universities.
According to the latest federal figures, medical abortions — generally a two-pill regimen using Mifeprex and the drug misoprostol — accounted for about 22 percent of abortions in the U.S. in 2013. Surgical procedures accounted for nearly all the other abortions.
Women using the pill generally take it in the privacy of their home. Noting that, Kaye said the legal case "is primarily about where a woman must be standing when she's handed the abortion pill that's been prescribed to her."
"The FDA restriction defies common sense," she said. "There's no medical issue in whether she's handed the pill at a pharmacy or at a clinic."
There is precedent for a federal court to overturn FDA restrictions. In 2013, a federal judge in New York ordered that the most common version of the morning-after pill must be accessible over-the-counter for all customers of all ages, instead of requiring a prescription for girls 16 and younger.
What would you do if you needed an abortion and you lived in place where there were no abortion clinics?
That’s a real-life question faced by women living in countries where abortion still isn’t legal — but it’s also faced by American women, even today. Dr. Graham Chelius, a doctor on the island of Kauai in Hawaii, knows exactly the level of hardship women face when they don’t have access to an abortion clinic. That’s because there isn’t one on his island. And he, along with the ACLU, is suing to make the abortion pill available in pharmacies.
The abortion pill was used in for 43 percent of abortions in Planned Parenthood clinics in 2014, a number that Reuters reports has most likely gone up in the last three years. It can be used to terminate a pregnancy up to 10 weeks. It’s also safe — safer than a lot of over-the-counter drugs, including Tylenol. In the first 18 months after it was approved in the United States, 80,000 women used it to terminate a pregnancy, according to the association of Reproductive Health Professionals. The same report found that of those women, only 139 — or 0.17 percent — “experienced an adverse effect.” Even more striking, in the first eight years, 850,000 women used the abortion pill to terminate a pregnancy and seven women died. However, there was no causal relationship found between their deaths and the abortion pill. In comparison, in the seven years between 1993 and 2000, the FDA received more than 4,000 reports of adverse effects — including 55 deaths — from Claritin.
Julia Kaye, a staff attorney with ACLU's Reproductive Freedom Project, told NPR that many women prefer the abortion pill to a surgical abortion because it “feels more natural to them, like a miscarriage.” Women can take the pill in the comfort of their own home, surrounded by loved ones if they choose. They don’t have to undergo a surgical procedure, which can feel scary and daunting.
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