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FDA says medication abortion drug can be distributed by mail during pandemic

The move, freeing up a type of non-surgical abortion effective earlier in pregnancy, further expands abortion access under President Joe Biden and marks a victory for the slew of abortion rights groups, medical groups and congressional Democrats that have put pressure on the administration in recent months to go further in reducing barriers to abortion.
Access to mifepristone has been at the center of a legal fight during the pandemic. In response to a lawsuit last summer, federal courts blocked the requirement the drug be dispensed in person, citing dangers of Covid-19 transmission. The Supreme Court, siding with the Trump administration, later reinstated the requirement.
The Food and Drug Administration on Monday lifted the requirement, it said in a letter to the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine.
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The FDA reviewed several studies concerning the health implications of the regulations and found that the outcomes “do not appear to show increases in serious safety concerns … occurring with medical abortion as a result of modifying the in-person dispensing requirement during the COVID-19 pandemic,” according to the letter.
“Given that the in-person dispensing of mifepristone for medical termination of early pregnancy may present additional COVID-related risks to patients and healthcare personnel because it may involve a clinic visit solely for this purpose,” the letter continues, the FDA’s Center for Drug Evaluation and Research “intends to exercise enforcement discretion during the COVID-19 (public health emergency) with respect to the in-person dispensing requirement.”
Medication abortion, a nonsurgical procedure effective until about 10 weeks into a pregnancy, typically entails taking two drugs several days apart. The contested regulation concerns mifepristone, the first drug, which works to block the hormone progesterone necessary for a pregnancy to continue.
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The FDA information page on mifepristone states that the drug “may only be dispensed in clinics, medical offices, and hospitals by or under the supervision of a certified healthcare provider,” but does not specify where the patient must take it. The second drug taken in a medication abortion, misoprostol, causes cramps and heavy bleeding as the uterus expels its contents. It can be taken “at a location appropriate for the patient,” according to the FDA.

Long legal fight

The current legal battle over mifepristone dates back to the early months of the pandemic, following several states’ efforts to limit abortion access in labeling it an elective procedure that could be limited under state orders professing to protect stores of personal protective equipment.
Several reproductive health groups, represented by the American Civil Liberties Union, sued the FDA, arguing that it was unconstitutional for the agency to maintain the rule for the abortion drug while lifting it for other drugs in light of the pandemic. A federal court sided with the groups and temporarily blocked the requirement in July, and a federal appeals court denied the Trump administration’s efforts to overturn the ruling in August.
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The Trump administration asked the Supreme Court to step in, but the then-eight-member court declined to do so in October and sent the case back to the lower court. After the lower court upheld its own block on the rule in December, the Trump administration returned to the Supreme Court, which granted its request to reinstate the restrictions for patients seeking to obtain the drug while the case on the regulations before the appeals court plays out.
Biden Justice Department lawyers are due to indicate this week to a federal appeals court this week whether they intended to continue the litigation.
Support for fundamentally reassessing the medication abortion regulation has been building on the left for months. The Congressional Pro-Choice Caucus, as well 55 groups including Planned Parenthood and the Center for Reproductive Rights, have urged the Biden administration to review the in-person requirement both during and after the pandemic.
Abortion rights and civil liberties groups cheered the policy change and called for further review of the requirements extending past the pandemic. In a statement following the announcement Georgeanne Usova, senior legislative counsel at the ACLU, said that “we cannot stop here: the restrictions on medication abortion are outdated and have obstructed patients’ access for far too long,” criticizing “medically unnecessary, harmful obstacles.”
Anti-abortion groups, however, slammed the administration for removing regulations on the procedure. March for Life President Jeanne Mancini said that medication abortions “should have more medical oversight, not less.”
The President has previously moved to support abortion rights across a slew of different policies. The Biden administration asked the Supreme Court in March to dismiss a dispute over a Trump-era rule barring federally funded health care providers in the Title X family planning program from referring patients for abortions. Later that month, the Department of Health and Human Services announced that it would issue a new proposed rule for the program in light of directives to ensure against “undue restrictions” on “federal funds or on women’s access to medical information.”
In a January memorandum, Biden fulfilled a campaign promise to rescind the so-called Mexico City Policy, a ban on US government funding for foreign nonprofits that perform or promote abortions, and directed the Department of Health and Human Services to immediately move to consider rescinding the Title X rule.
Many other court cases are making their way to the conservative-leaning Supreme Court, outside of the Biden administration’s purview. In February, South Carolina Gov. Henry McMaster signed a bill prohibiting an abortion if a fetal heartbeat is detected during an ultrasound with few exceptions, becoming the latest Republican to sign a so-called heartbeat bill. And in March, the Arkansas state House and Senate moved to make it the first state to enact a near-total abortion ban in 2021.
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