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Oregon and Washington sue FDA over restrictions on abortion pill

Mifepristone, a medication used to end pregnancy, is more tightly regulated than other medications and 12 state attorneys general are registering their objections
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Abortion pills. | PHOTO BY VALASIURUA/WIKI COMMONS
February 25, 2023

The Democratic attorneys general of Oregon and Washington have filed a lawsuit against the federal Food and Drug Administration. They are challenging its regulation of the drug mifepristone which is used in medication abortions and in managing miscarriages.

The drug is used in combination with the medication misoprostol to end pregnancies at up to 10 weeks gestation. Medication abortion is the most common form of abortion in the United States and it’s become a flashpoint for legal battles over access to abortion.

The drug is also at the center of a federal lawsuit in Texas in which a conservative group has sued the FDA for approving the medication more than 20 years ago. That’s the opposite of the concern from the Oregon and Washington Attorneys General, who say the drug is too tightly regulated.

“Our coalition stands by our belief that abortion is healthcare, and healthcare is a human right,” Oregon Attorney General Ellen Rosenblum said in a statement Friday, referring to a coalition of states suing the FDA.

Mifepristone is part of a FDA drug safety program that imposes special requirements on drugs the agency considers higher risk.

According to the FDA, the extra scrutiny is warranted due to a rare infection that might be associated with the drug and has caused nine deaths over the past 20 years.

Mainstream medical groups, including the American College of Obstetricians and Gynecologists oppose the regulations. In a position statement, the OBGYN association called the regulations medically unnecessary and said the FDA appears to be subjecting abortion medications to a unique and higher standard than other drugs.

In response to several other lawsuits, the FDA recently started rolling back some of the more unusual restrictions it placed on mifepristone, for the first time allowing retail pharmacies to dispense it to people with a prescription. But the agency still requires health care providers to get a special certification in order to prescribe it.

The attorneys general say mifepristone is safer than Tylenol and the FDA’s restrictions have made it harder for patients who need the drug to get it.

Twelve states have signed on to the lawsuit, which was filed in U.S. District Court for the Eastern District of Washington: Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, New Mexico, Nevada, Oregon, Rhode Island, Vermont and Washington.

This article was originally published by Oregon Public Broadcasting and is republished here with permission.

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