The American Civil Liberties Union (ACLU) has filed a lawsuit against the federal restrictions imposed by the FDA against using Mifeprex, supposedly an abortion pill. Reportedly, the FDA has placed restrictions on the drug ever since the year 2000, when the drug was first approved. According to the restrictions imposed, Mifeprex is not supposed to be sold in pharmacies and all the other approved providers of Mifeprex would be required to go through a special certification process. Recently in 2016, the FDA issued new guidelines for using Mifeprex, and has unapologetically stated that the restrictions imposed on the drug access and usage would not undergo any change whatsoever. The agency reportedly stands firm on its decision, on the grounds of which the American Civil Liberties Union (ACLU) has filed a lawsuit, demanding lifting some of the restrictions on the drug usage.
The lawsuit has reportedly been filed in U.S. District Court, Hawaii, and targets the removal of the long-standing restrictions enforced by the Food and Drug Administration. The FDA mandates that the pill, commercially called Mifeprex in the United States, can be sold only to hospitals and clinics. The drug can apparently be used to induce abortions up to 10 weeks of pregnancy, and the lawsuit filed by the ACLU demands that it should be made available in all the pharmacies spanning the United States, as opposed to merely being available at clinics and doctors’ offices, which has considerably limited the access to this pill for the women populace.
Reportedly, an attorney with the American Civil Liberties Union Reproductive Freedom Project, Julia Kaye, states that Mifeprex is medically safe and effective, and that the FDA imposing restrictions on its marketing and making it inaccessible to women who need access to the drug is not based on medical science, but an abortion stigma.
A recent commentary published in the New England Journal of Medicine earlier this year, reports that the FDA has been notified regarding 19 deaths among the 3 million women who used Mifeprex since 2000 – this mortality rate is significantly lower than even pregnancy-related deaths occurring among women. The commentary also paved way for supporting ACLU’s lawsuit, stating that lifting the restrictions would enable many doctors to willingly prescribe Mifeprex without having to store the drug at their office and without having to fear being listed among certified abortion providers. Additionally, they conclude, that the restriction ban may also help to enable women residing in rural areas to have access to abortions, if the drug is made available via telemedicine.
The suit has been filed on behalf of 3 health care associations and Dr. Graham Chelius, noted physician working in Kauai, Hawaii. The lawsuit also has the support of the American Congress of Obstetricians and Gynecologists. In addition, the CEO of this organization, Dr. Hal Lawrence, was quoted stating that the FDA restrictions do not seem to be grounded on any suitable medical justification, which totally negates the necessity of enforcing the regulations.
Saipriya Iyer develops content for Market Size Forecasters. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her belt, she has dabbled with website content writing, content auditing, tech w...