Federal judge rules women can get the abortion pill without visiting a doctor

SILVER SPRING, Md. (AP) — A federal judge Monday agreed to stay a rule that requires women to visit a hospital, clinic or doctor’s office to receive an abortion pill during the COVID-19 pandemic.

U.S. District Judge Theodore Chuang in Maryland concluded that the “personal requirements” for patients desiring medical abortion treatment present a “significant impediment” to abortion patients and are likely unconstitutional in the circumstances of the pandemic.

“Particularly given the limited time frame in which medical abortion or abortion must occur, such a violation of the right to an abortion would constitute irreparable harm,” the judge wrote in his 80-page decision.

Chuang’s decision will allow healthcare providers to arrange for the shipment or delivery of mifepristone to patients during the public health emergency declared by the Secretary of the US Department of Health and Human Services. The US Food and Drug Administration has approved mifepristone for use in combination with a second drug, misoprostol, to terminate an early pregnancy or treat a miscarriage.

“By forcing certain patients to choose between forgoing or significantly delaying abortion treatment or risking exposure to COVID-19 for themselves, their children and family members, the personal demands of many abortion patients place a serious burden” , Chuang wrote.

READ MORE: Doctors are suing to block FDA rule on abortion pill during pandemic

The American College of Obstetricians and Gynecologists and other groups sued HHS and the FDA in May to contest the rule.

Skye Perryman, chief legal officer of the American College of Obstetricians and Gynecologists, said the FDA’s restrictions on mifepristone are not medically necessary and “do not promote the health and safety of patients.”

“Today’s ruling recognizes the hardship and undue burden many women have faced to obtain essential health care during the COVID-19 pandemic,” Perryman said.

Attorneys for plaintiffs from the American Civil Liberties Union argued that the FDA’s personal requirements violate a woman’s constitutional rights to an abortion and violate the due process clause of the Fifth Amendment.

Government attorneys have argued the requirements are necessary to ensure patients use mifepristone safely. FDA regulation requires patients to pick up the individual mifepristone tablet at a hospital, clinic, or doctor’s office and sign a form that provides information about the drug’s potential risks.

The judge said the suspension of the requirements was in line with public health guidance to avoid unnecessary travel and face-to-face contact.

Chuang granted the ACLU’s request for a due process injunction. He noted that federal agencies have waived personal requirements for many other drugs “for the specific purpose of protecting public health.”

The group’s lawsuit states that mifepristone is the only one of more than 20,000 FDA-regulated drugs that patients must receive in person at a hospital, clinic or doctor’s office, “yet they self-administer, unsupervised, at a location of their choice.” be able”.

The judge did not place any geographic restrictions on the injunction. Referring to the nature of the pandemic, he said that “it is simply impossible to create relief efforts that attempt to address both the unpredictable changes and the nuanced regional differences across 50 different states over an extended period of time.”

The states of Indiana, Louisiana, Alabama, Arkansas, Idaho, Kentucky, Mississippi, Missouri, Nebraska and Oklahoma had asked to intervene in the lawsuit. The 10 states argued that the case could impact how they enforce their own state laws that refer to or reference the FDA’s mifepristone regulation.

Chuang turned down her application last month. The judge said the federal case would not deprive any state of the ability to regulate medical abortion “above and beyond FDA requirements.”

More than 4 million people in the US have used mifepristone and misoprostol to terminate an early pregnancy; The two-drug combination accounted for 39% of all U.S. abortions in 2017, the lawsuit says.

The lawsuit states that the FDA rule has “particularly severe implications for low-income people and people of color, who account for a disproportionate proportion of affected patients and who are already suffering and dying from COVID-19 at substantially higher rates.”

In March, dozens of anti-abortion activists signed a letter to HHS Secretary Alex Azar calling for abortion practices to be halted during the pandemic. “Their continued operation is depleting much-needed personal protective equipment and creating complications that will further overwhelm already-overwhelmed emergency rooms,” the letter said.

Azar and FDA Commissioner Stephen Hahn were also named as defendants in the lawsuit.

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