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ACLU files lawsuit to challenge FDA regulation that ban sales of abortion pills in pharmacies

(Reuters/Jason Reed)FILE PHOTO: A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. Picture taken August 14, 2012.

The American Civil Liberties Union (ACLU) has filed a lawsuit on Tuesday in an attempt to challenge the U.S. Food and Drug Administration regulation that prohibit the sales of the abortion pill Mifeprex in retail pharmacies.

In a lawsuit filed in U.S. District Court in Hawaii on Tuesday, the ACLU argued that the FDA is restricting women's access to abortion by limiting the dispensing of the pill to clinics, medical offices or hospitals rather than retail pharmacies.

Under the FDA regulation, the pill must be provided at a medical office or hospital under the supervision of a medical professional, and only under the terms that the physician has registered with the pill's manufacturer, the ACLU noted in the lawsuit.

The woman seeking an abortion is also required to sign an agreement that she has received counseling on the risks associated with taking the drug.

The law group contends that Mifeprex, which can be used for abortions up to 10 weeks into a pregnancy, has been considered safe and even recognized by the FDA as "meaningful therapeutic benefit."

"The unique and harmful restrictions the FDA imposes on where and how a patient may receive Mifeprex deny women meaningful access to this safe and effective treatment with no medical justification," the ACLU stated in the complaint.

Reuters noted that the drug has been approved in 2000 for abortions in early stages of pregnancy when given in combination with misoprostol, an anti-inflammatory drug that was originally approved to prevent gastric ulcers.

In March 2016, the FDA announced a decision to ease restrictions on the use of the abortion pill that have been in place for over a decade.

The FDA changed the guidelines for the drug, allowing it to be used up to 70 days of gestation instead of just 49 days, cutting the recommended dose of the drug and reducing the number of required visits to the doctor.

Dr. Graham Chelius, an OB-GYN in Waimea, Hawaii, claims that pregnant women on his island must travel elsewhere for abortions due to the lack of abortionists. The doctor, who is one of the plaintiffs in the case, stated that if the FDA regulations were lifted, he would be willing to write a prescription for the women, thus making abortion more readily available.

The ACLU is seeking a court order to remove the FDA restrictions as well as an injunction against the agency's Risk Evaluation and Mitigation Strategy (REMS) on Mifeprex.

"Lacking any medical basis, they do not improve women's health. Rather, by delaying and blocking access to abortion care, they harm women's health. The restrictions thus violate both the due process protections of the U.S. Constitution and the statutory authority under which the FDA must operate," the law group wrote in a blog post.

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