CNA Staff, Dec 10, 2020 / 17:01 pm
A federal judge on Wednesday refused to lift an order barring Food and Drug Administration requirements that the abortion pill be administered in person, after the US Supreme Court sent the case back to a lower court in October.
In July, Judge Theodore D. Chuang of the US District Court for the District of Maryland ruled that the FDA listing of the abortion pill regimen alongside higher-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 mifepristone. Justice Department attorneys appealed the order.
Chuang maintained that decision Dec. 9, writing that "particularly in light of the substantial spread of COVID-19 in recent weeks that increases the risk of all travel, the Court does not find that any changes to economic conditions or access to medical facilities, childcare, or transportation since the issuance of the (prior block on the rule) have been so favorable as to constitute changed circumstances" to justify lifting the block.
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 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.
A medical abortion, sometimes called a chemical abortion, is a two-step process that involves the ingestion of mifepristone and misoprostol. The first drug, mifepristone, effectively starves the unborn baby by blocking the effects of the progesterone hormone, inducing a miscarriage. Misoprostol is taken up to two days later and induces labor.
Under the FDA's guidance, mifepristone "may only be dispensed in clinics, medical offices, and hospitals by or under the supervision of a certified healthcare provider."
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, 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. The ruling allows health care providers to arrange for mifepristone to be mailed or delivered to patients during the pandemic, the AP reported.
After Chuang's initial 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.
The FDA has recorded 24 deaths of women associated with the drugs, as well as more than 4,000 cases with adverse effects since 2000.
The US Supreme Court in early October refused to reverse Chuang's order, sending the case back to the district court. The Supreme Court did not rule on the merits of the district court's decision, but said the government could present new evidence in the case and directed Chuang to issue a new ruling within 40 days.
Justice Samuel Alito, in a dissent, noted that the FDA adopted the regulation at issue in 2000, it has been enforced over the course of four administrations, and the agency "evidently decided that the mifepristone requirement should remain in force" during the pandemic.
"Nevertheless," Alito wrote, "a District Court Judge in Maryland took it upon himself to overrule the FDA on a question of drug safety."
A push for in-home medical abortions during the pandemic is also playing out abroad.
In March the British government announced that women would be allowed to receive abortion pills via mail and perform the full medical abortion at home for the duration of the pandemic.
The UK government opened a consultation period on the matter Nov. 26 which runs through February 2021, seeking feedback on whether to make the temporary allowal permanent.
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