Health Care

ACLU sues FDA over abortion pill restrictions

ACLU sues FDA over abortion pill restrictions”

The American Civil Liberties Union (ACLU) [advocacy website] filed a lawsuit [complaint] in the US District Court for the District of Hawaii [official website] Tuesday against the US Food and Drug Administration (FDA) [official website] related to regulations for the administration of the abortion pill Mifeprex.

Under the current regulatory system, the pills are dispensed at a qualified medical facility, and a woman takes the medication at home. These restrictions are imposed by the FDA when "necessary because of the "inherent toxicity or potential harmfulness" of a drug". In addition, the providers must be pre-registered with the drug manufacturer, must have the medicine in stock, and must be able to provide a surgical abortion if any complications caused by the pills arise.

The ACLU said that as a result, the FDA's restrictions delay and in some cases block a woman's access to abortion by requiring her to be handed Mifeprex by healthcare providers who have arranged to stock it in their facilities.

The University of California, Berkeley has a Self-Induced Abortion Legal Team, a nonprofit group that "envisions a world" where abortion drugs are as easy to buy as the morning-after pill, according to the Christian Science Monitor. The ACLU notes that there are several other prescription abortion drugs which are not subject to these requirements. Regarding the lawsuit, it said the agency does not comment on pending or ongoing litigation.

Although plaintiff Dr. Graham Chelius, a family medicine doctor on Kaua'i, is qualified and willing to provide medication abortion, he can not stock the abortion pill at the hospital where he works. "Unfortunately, because of the FDA's restrictions, my patients are forced either to fly to a different provider on another island-resulting in serious delays-or to carry a pregnancy to term against their will". This could be avoided if the pill were available at pharmacies on Kauai. This lawsuit argues that the FDA's burdensome restrictions on medication abortion fail that test.

Because of the high failure rate and the risks involved with the abortion drug in later pregnancies, the FDA limited approval for use only in the first 49 days from the start of a woman's last menstrual period.

Julia Kaye, a staff attorney with ACLU's Reproductive Freedom Project, argues that it's time for the FDA to allow women to fill those prescriptions at pharmacies - a move that could substantially expand access to medication abortions.

Mifeprex, manufactured by Danco Laboratories, was approved in 2000 to terminate early pregnancy when given in combination with misoprostol, an anti-inflammatory drug that was originally approved to prevent gastric ulcers.

In a statement previous year, ACOG's past president, Dr. Mark S. DeFrancesco, said that while fatal infections have been reported in rare cases, "it is important to note that no specific connection exists between medication abortion and these infections, which can also occur with other obstetric and gynecologic processes and procedures".

"The FDA restriction defies common sense", she said.

"Is the pharmacist going to answer her call at 5 in the morning when she's suffering or needs some help?" In 2013, a federal judge in NY 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.



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