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FDA decision will boost access to medication abortions in Fargo, elsewhere

BISMARCK - Abortion opponents suffered a blow Wednesday when the U.S. Food and Drug Administration approved a new label expanding the authorized use of a drug used in medication abortions, making the option cheaper and accessible to "many more wo...

BISMARCK – Abortion opponents suffered a blow Wednesday when the U.S. Food and Drug Administration approved a new label expanding the authorized use of a drug used in medication abortions, making the option cheaper and accessible to “many more women,” a lawyer for North Dakota’s sole abortion provider said.

State lawmakers passed a bill in 2011 banning medication abortions involving the “off-label” use of a prescription drug. That prompted the Red River Women’s Clinic in Fargo to temporarily halt the service in October 2014 after an unsuccessful legal challenge that ended with the state Supreme Court upholding the law.

The clinic had offered medication abortions at up to nine weeks of pregnancy since 2007 using two prescription drugs: Mifeprex and misoprostol, an anti-inflammatory drug that was originally approved to prevent gastric ulcers.

The clinic resumed medication abortions after several months. But the option was limited to women at seven weeks of pregnancy or less because the new law forced the clinic to follow a more restrictive FDA label for Mifeprex that had been in place since 2000, said Autumn Katz, an attorney with the New York-Based Center for Reproductive Rights, which has represented the clinic in court.

Women also were required to return to the clinic to take misoprostol instead of taking it at home, which opponents of the law said discouraged medication abortions because women begin to experience bleeding, cramping and other symptoms soon after ingesting the drug.

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“It precluded a lot of women who might otherwise have been interested,” Katz said.

On Wednesday, the FDA increased the authorized use of Mifeprex to 10 weeks of gestation from the current seven weeks, cut the recommended dose of the drug and reduced the number of required visits to a doctor.

The changes are expected to allow greater access to medication abortions, particularly in North Dakota, Texas and Ohio, which have laws banning off-label use. Similar laws in Arizona, Arkansas and Oklahoma have been blocked by the courts as legal challenges proceed.

The FDA updated the Mifeprex requirements to bring them in line with the most up-to-date scientific studies, which have shown that a third of the dose works as well.

“Given the restrictions on medication abortion enacted at the state level in recent years, updating the label to reflect best medical practice represents a significant step forward for science, for women, and for health care providers who want to give women the highest quality care,” Amy Jacobson, North Dakota manager of advocacy and development for Planned Parenthood Minnesota, North Dakota, South Dakota, said in a statement.

As far back as 2001, an estimated 83 percent of U.S. providers were no longer using the old FDA-approved regimen, according to the Guttmacher Institute, which backs abortion rights but whose research is used by both sides of the debate.

The National Right to Life organization warned that the FDA decision doesn’t make medication abortions safer and only benefits the abortion industry.

“It is clear whose interests it is the FDA is serving. It isn't the women, and it isn't the babies,” education and research director Randall O’Bannon said in a statement.

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Katz said she sees no need for new legal challenges to the North Dakota law, though the center still feels parts of it are unnecessary. She called the FDA decision a “very positive development” that will allow the clinic to provide safe and high-quality care, which includes not limiting the options available to women.

“And unfortunately that’s what the Legislature of North Dakota decided to do,” she said.

 

Reuters contributed to this article.

Related Topics: ABORTION
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