Supreme Court Could Rule Soon on Abortion Pill Regulations
Since 2000, the FDA has placed the chemical abortion protocol of mifepristone and misoprostol—allowed in the U.S. for abortions up to 10 weeks in a pregnancy—under its Risk Evaluation and Mitigation Strategy (REMS) list, requiring it to be prescribed in-person in a hospital, clinic, or medical office.
WASHINGTON — The Supreme Court could soon rule on a major abortion case, after the Trump administration appealed to maintain safety regulations of the abortion pill.
The Justice Department (DOJ) filed an Aug. 26 emergency motion at the Supreme Court to halt a federal district court’s decision from going into effect that would nullify federal regulations of the abortion pill during the new coronavirus pandemic.
In July, federal judge Theodore Chuang of Maryland ruled that the U.S. Food and Drug Administration’s (FDA) listing of the abortion pill regimen alongside higr-risk procedures and drugs posed an undue burden on women seeking abortions during the pandemic, because it required them to travel to a medical facility to obtain the abortion pills. Chuang, and a federal circuit court which upheld his ruling in August, said that women should be able to take abortion pills without a visit to a doctor’s office.
Since 2000, the FDA has placed the chemical abortion protocol of mifepristone and misoprostol—allowed in the U.S. for abortions up to 10 weeks in a pregnancy—under its Risk Evaluation and Mitigation Strategy (REMS) list, requiring it to be prescribed in-person in a hospital, clinic, or medical office. The patient must sign a form acknowledging that she has been adequately informed of the risks.
Pro-abortion groups, however, have pushed for the pill to be dispensed remotely via telemedicine during the coronavirus pandemic, due to apparent difficulties women could face traveling to a clinic in-person.
On July 13, Judge Chuang ruled that the REMS requirement of an in-person clinic visit doesn’t have to be applied during the pandemic, allowing for the abortion pill regimen to be prescribed remotely.
In its August emergency appeal to the Supreme Court, the DOJ said that “as a result of the injunction, the FDA cannot enforce longstanding safety requirements that have been judged necessary to mitigate serious risks to patients who use Mifeprex to effectuate an abortion.”
After Judge Chuang’s decision, pro-life leaders and senators asked the FDA to remove the abortion pill from the market altogether by classifying it as a public health hazard. Nearly two dozen pro-life leaders said that pro-abortion groups were “using the coronavirus pandemic as a ruse” in their efforts to deregulate the pill.
In its brief, the DOJ argued that in-person requirements do not pose an “undue burden” on women seeking abortions.
The DOJ said that “a regulatory requirement imposed on one abortion method is not unconstitutional when another safe abortion method remains readily available.”
The pro-abortion groups which brought the case to federal court responded to the DOJ’s motion on Tuesday.
They said that the FDA’s in-person dispensing requirement presented an “unnecessary COVID-19 risk” to women and that the FDA had already allowed for other drugs to be prescribed via telemedicine during the pandemic.
“Defendants have not, and cannot, offer any legitimate explanation why only clinicians prescribing a medication used for abortion care—not clinicians prescribing any other, far less safe drug—should be subject to this singular restriction that prevents them from exercising their medical judgment to provide care to their patients in the safest possible manner during the pandemic,” their brief stated.