Supreme Court set to decide on abortion pill access

WASHINGTON, April 21 (BNA): The Supreme Court faces a self-imposed deadline Friday night to decide whether a woman’s access to widely used abortion pills will remain unchanged or restricted during a legal challenge to the FDA’s approval. On, the Associated Press (AP) reported.


The justices are examining arguments that allowing restrictions in lower court rulings to apply would severely disrupt the availability of mifepristone, which is used in the most popular method of abortion, in the United States.


It has been repeatedly found to be safe and effective, and more than 5 million women in the United States have used it since the Food and Drug Administration approved it in 2000.


The Supreme Court initially said it would decide by Wednesday whether the restrictions would go into effect while the case was ongoing. A one-sentence order signed by Judge Samuel Alito on Wednesday gave the judges two more days without explanation.


The justices are scheduled to meet for a private conference on Friday, where they can talk about the case. The extra time may be part of trying to craft a system that has broad support among the justices. Or one or more judges may write a separate opinion and request an additional two days.


The challenge to mifepristone, brought by abortion foes, is the first abortion-related controversy to reach the nation’s highest court since conservative majorities overturned Roe v. Wade 10 months ago and allowed more than a dozen states to outright ban abortion.


In the majority opinion, Alito said one of the reasons for dropping Roe was to remove federal courts from anti-abortion. “It is time to pay attention to the constitution and return the issue of abortion to the people’s elected representatives,” he wrote.

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But even after their victory in court, abortion opponents are back in federal court with a new target: medical abortion, which makes up more than half of all abortions in the United States.


Women seeking to terminate their pregnancy in the first 10 weeks without a further invasive surgical abortion can take mifepristone, along with misoprostol. The Food and Drug Administration has relaxed the conditions for use of mifepristone over the years, including allowing it to be sent through the mail in states that allow access.


Abortion opponents sued in Texas in November, arguing that the FDA’s original approval of mifepristone 23 years ago and subsequent changes were flawed.


They won an April 7 ruling by US District Judge Matthew Kacsmarek, an appointee of former President Donald Trump, to revoke the FDA’s approval of Mifepristone. The judge gave the Biden administration and New York-based Danco Laboratories, which makes mifepristone, a week to appeal and seek to keep its ruling pending.


In response to a speedy appeal, two Trump appointees to the Fifth Circuit to the US Court of Appeals said the FDA’s original approval would stand for now. But Justices Andrew Oldham and Kurt Englehart said most of the remaining provisions in Kaksmarek’s ruling could become effective by the time the case is decided in federal courts.


Their ruling would overturn changes made by the FDA from 2016, including extending the gestational age from seven to 10 weeks when mifepristone can be used safely. The court also said that the drug cannot be mailed or dispensed as a generic drug and that patients who seek it need to have three in-person visits with a doctor. Women may also be required to take higher doses of the drug than the FDA says is necessary.

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The administration and Danco said chaos would ensue if these restrictions went into effect while the case was ongoing. Adding to the potential confusion, a federal judge in Washington ordered the FDA to maintain access to mifepristone under existing rules in 17 Democratic-led states and the District of Columbia that filed a separate lawsuit.


The Biden administration said the provisions conflicted and created an intolerable situation for the Food and Drug Administration.


A new legal wrinkle threatens to add complications. GenBioPro, which makes the generic version of mifepristone, filed a lawsuit Wednesday to prevent the Food and Drug Administration from preemptively removing its drug from the market, in the absence of the Supreme Court’s intervention.


Currently, the Supreme Court is only required to block lower court decisions until the end of the legal case. But management and Danco have a backup argument if the court disagrees. They are asking the court to accept the challenge to mifepristone, hear the arguments and decide the case by early summer.


The court rarely takes such a step before at least one appellate court has carefully examined the legal issues involved.


The New Orleans-based Fifth Circuit has already ordered a fast-track schedule for hearing the case, with arguments set for May 17.


AOQ






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