On Wednesday, Justice Samuel Alito of the Supreme Court prolonged a temporary stay of a lower court’s order restricting the use of the common ab0rtion dr*g mifepristone until Friday at 11:59 p.m.
The Supreme Court will have more time to consider the emergency requests from the Biden administration and dr*g maker Danco Laboratories to stop an appeals court decision that reversed a number of Food and Dr*g Administration actions since 2016.
The brief order issued by Alito preserves widespread access to mifepristone for two more days — his initial temporary hold was scheduled to expire Wednesday at midnight — and gives the court more time to consider the emergency requests.
These modifications lowered the number of in-person clinic visits necessary to obtain a prescription, raised the gestational age restriction for utilizing the medication from 7 weeks to 10 weeks, and expanded the pool of medical professionals qualified to do so.
Additionally, the FDA authorized the mail-order distribution of mifepristone in 2021 and approved a generic version in 2019.
Since Matthew J. Kacsmaryk, a federal district judge in Texas, revoked the FDA’s 23-year-old approval of the dr*g in a ruling on April 7 that would disrupt access to the dr*g nationwide, including in places where abortion is permitted, the legal environment for mifepristone has changed significantly.
The FDA’s policy revisions since 2016 that loosened the restrictions on the dr*g were reversed by the U.S. Court of Appeals for the Fifth Circuit, which later placed on hold the most crucial portion of the district court’s decision – stopping the approval of mifepristone.
The Biden administration and Danco requested the Supreme Court’s intervention in response to the three-judge panel of the 5th Circuit’s divided judgment.
“If allowed to take effect, the lower courts’ orders would upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the dr*g, and FDA’s ability to implement its statutory authority,” Solicitor General Elizabeth Prelogar said of the lower court judgments in a filing to the Supreme Court.
Alito granted an administrative stay, ensuring that mifepristone would remain available while the Supreme Court evaluated the matter, hours after the Justice Department asked the court to intervene.
Since the Supreme Court reversed Roe v. Wade less than a year ago, when it threw the legal system into disarray and resulted in near-total bans on ab0rtion in more than 12 states, the controversy over the FDA’s approval of mifepristone is the most significant ab0rtion-related case to come before the court.
15 states have laws in place that make it more difficult for people to get medication ab0rtions, such as ones that demand a doctor prescribe the medicines.
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According to the Centers for Disease Control and Prevention, medication ab0rtions are becoming increasingly popular. They will make up more than half of all ab0rtions performed in the United States in 2020. To end an early pregnancy, mifepristone is used with misoprostol, a different medication.
According to the FDA, over 5 million women have used mifepristone to abort their pregnancies.
In court documents, the Justice Department argued that there is very little chance of experiencing a severe adverse event when using mifepristone as prescribed.
It cautioned that the lower court orders “would scramble the regulatory regime governing a dr*g that FDA determined was safe and effective under the approved conditions.”
The 5th Circuit’s judgment, however, restores “a modicum of safety” for the pregnant women who use the dr*g, according to a filing made on Tuesday with the Supreme Court by anti-ab0rtion doctors and medical associations that sued the FDA over the clearance of mifepristone.
They also claimed that it would not stop anyone from accessing the dr*g. Instead, they argued, the pill would be bound by the same limitations in force for the 16 years following its approval in 2000.
“Both the Fifth Circuit and district court orders paint an alarming picture of this lawlessness — all to the detriment of the women and girls FDA is supposed to protect,” they claimed.
The Alliance Defending Freedom filed a lawsuit on behalf of medical groups and anti-ab0rtion doctors in November, sparking the legal struggle against medication ab0rtion.
The challengers claimed that when the FDA approved mifepristone in 2000, it did not sufficiently weigh the dangers to human health and safety. The case was filed at the federal court in Amarillo, Texas, where former President Donald Trump appointed Kacsmaryk to preside over cases.
Kacsmaryk’s ruling prevented the FDA from approving mifepristone and taking the following steps to increase access to the medication.
However, according to the 5th Circuit, “it appears that the statute of limitations bars plaintiffs’ challenges to the Food and Dr*g Administration’s approval of mifepristone in 2000.” The government, however, “relied on zero studies that evaluated the safety- and effectiveness consequences of the 2016 changes,” according to the appeals court.
The Biden administration’s appeal of the district court ruling was also expedited by the 5th Circuit, which scheduled arguments for May 17.
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