Planned Parenthood: Amend abortion pill suit challenging Arkansas law

It says FDA rule OKs drug regime

In light of the U.S. Food and Drug Administration's decision late last month to update its protocol for administering medication abortions, Planned Parenthood is asking to amend its lawsuit challenging an Arkansas law.

A motion filed in federal court in Little Rock notes that the new protocol, announced March 29, is consistent with the regimen used by Planned Parenthood clinics in Little Rock and Fayetteville, as well as the majority of abortion providers across the country, so it moots the lawsuit's chief complaint.

The lawsuit was filed Dec. 28 to prevent the implementation of Act 577 of 2015, which was to take effect Jan. 1. It required abortion providers in the state to adhere to the FDA's protocol, which at that time Planned Parenthood said was outdated and less safe than the clinics' practices.

U.S. District Judge Kristine Baker granted a temporary restraining order Dec. 31 to prevent the state from enforcing the new law while the claims in the lawsuit were litigated. Baker then issued a preliminary injunction March 14 to extend the prohibition against enforcing the new law.

While the FDA's update has mooted the protocol complaint in the lawsuit, Planned Parenthood says in court documents that it still intends to pursue the lawsuit's other complaint -- that Act 577 requires abortion providers to contract with a physician who has admitting privileges at a designated hospital.

Planned Parenthood also wants to add a challenge to another provision of the law that requires follow-up visits within 14 days of taking the medication, to ensure the abortion is complete.

Planned Parenthood says the section of law requiring the physician contract is an impossible condition and would essentially stop it from providing abortions. Planned Parenthood clinics in Arkansas only provide medication abortions, not surgical abortions.

The follow-up visit requirement is burdensome to patients and unnecessary, according to Planned Parenthood.

The motion says attorneys for Arkansas have indicated they don't object to the complaint being amended to drop the protocol challenge but that they do object to it being amended to add the challenge to the law's follow-up provision.

Planned Parenthood says in the motion that it isn't seeking "any immediate relief" on its complaint about the required follow-up visit; in other words, it isn't seeking to add that complaint to the injunction.

The FDA in March approved a new label for a common abortion-inducing drug that undermines restrictions on medication abortions passed by several states. The label allows women to take the abortion drug later in a pregnancy and with fewer required office visits.

The FDA notified the manufacturer of Mifeprex in a letter March 29 that the drug is safe and effective for terminating a pregnancy in accordance with the new label. Also known as mifepristone, the drug is used in combination with another drug, misoprostol, to end a pregnancy.

Laws in states such as North Dakota, Ohio and Texas -- like the Arkansas law that hasn't yet taken effect -- have required providers to follow the requirements on the original FDA labels for the drug when administering medication abortions, despite complaints from many doctors that those labels were outdated. Doctors have said the state laws contradicted accepted medical practices and made it harder for women to get abortions.

Under the new FDA-approved label, mifepristone can be used up to 70 days after the beginning of a woman's last menstrual period, instead of the 49-day limit in effect under the old label.

Mifepristone blocks the production of progesterone, a hormone that prepares the lining of the uterus for a fertilized egg. A day or two after taking that drug, the woman takes the second drug, misoprostol, which causes the uterus to contract and expel the pregnancy.

Under the new label, the second drug can be taken at home and is not required to be administered at a clinic, which would reduce the number of trips women have to make to a doctor for a medication-induced abortion from three to two in most states, experts say.

The new label also reduces the dosage of mifepristone from 600 milligrams to 200 milligrams. Medical experts have said the previous dosage was too high, while abortion-rights advocates have said it increased the cost and the side effects of the procedure.

The label also relaxes prescriber guidelines to allow, for example, a nurse practitioner to administer the drugs rather than a physician.

Metro on 04/29/2016

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