After the United States’ Supreme Court revoked the constitutional right to abortion last year, now the distribution of a key pill to terminate pregnancies has come under threat in the country.
A federal judge in Texas heard the lawsuit on Wednesday (15 March) that seeks to overturn the US Food and Drug Administration’s (FDA) approval of the widely used abortion drug – mifepristone.
The federal judge of the Northern District of Texas, Matthew Kacsmaryk, said he would give a ruling “as soon as possible,” without elaborating further, reported Associated Press (AP).
People, who are against the lawsuit had gathered outside the federal court in Amarillo, Texas, holding placards that read: Defend Medication Abortion.
How does mifepristone work? What is the case against the abortion pill and how will the ruling impact access to abortion in the US? Let’s take a closer look.
Medication abortion
More than half of women in the US who terminate pregnancies adopt the method of medication abortion.
Mifepristone was approved by the FDA in 2000 in combination with another pill – misoprostol – to end pregnancies until the 10th week of conception.
A patient takes one mifepristone pill which causes the uterine lining to break down. Around 24 hours later, a four-pill dose of the second drug – misoprostol – is taken to expel the embryo or fetus, reported The Washington Post. This second pill also has other medical purposes.
Misoprostol can also be used alone for abortion but studies show it is less effective than the two-step regimen.
Mifepristone has been used in Europe for nearly three decades now and it is considered a safe way of terminating a pregnancy.
Between September 2000 and December 2018, 24 of the more than 3.7 million women who opted for medicated abortions died, according to Forbes.
Case against mifepristone
Last November, Alliance Defending Freedom, a Christian legal advocacy group, filed the lawsuit against the FDA in Texas on behalf of four anti-abortion medical organisations and four doctors.
The conservative group makes three points about why mifepristone should be pulled off shelves.
Firstly, the lawsuit says the FDA misused its authority when it gave nod to mifepristone in 2000 which had reviewed the drug under its “accelerated approval” program.
It also claims that the drug was not checked for safety properly at the time, alleging the government ignored the pill’s “harmful side effects”, as per The Washington Post.
The lawsuit also claims that it is illegal to sell the drug under the Comstock Act of 1873 which prohibits mailing anything “designed, adapted or intended for producing abortion, or for any indecent or immoral use.”
However, in December 2022, the US Department of Justice’s Office of Legal Counsel said the Act does not prevent the mailing of abortion drugs intended for legal use, reported BBC.
Erik Baptist, senior counsel at Alliance Defending Freedom, said “the goal of this lawsuit is to protect American women and girls from dangerous chemical abortion drugs”, reported NBC News.
“We are not seeking a nationwide abortion ban — we’re focusing on one means of abortion here because it’s dangerous, and we are holding the FDA accountable for failing America’s women and girls,” Baptist added.
ALSO READ: The sharp decline in women’s rights across the world
What does the FDA say?
The FDA has rejected the charge that it had expedited the approval of the drug, which was done after four years of deliberation.
President Joe Biden’s administration has said the approval was backed by science and that removing the pills from the market would lead to worse health outcomes for people seeking abortions, reported NBC News.
The US Justice Department said in a court filing that the lawsuit can undercut the nation’s process for regulating pharmaceuticals.
“The injunction request is extraordinary and unprecedented,” the Justice Department said, as per The Washington Post.
“Plaintiffs have pointed to no case, and the government has been unable to locate any example, where a court has second-guessed FDA’s safety and efficacy determination and ordered a widely available FDA-approved drug to be removed from the market.”
Last July, the Justice Department set up a reproductive rights task to monitor state legislation and enforcement actions that threaten to “infringe on federal legal protections” related to reproductive healthcare. This came a month after the Supreme Court overturned the landmark 1973 Roe v Wade.
Now the officials of this task force are keenly watching the Texas lawsuit.
“We are vigorously defending the FDA in unprecedented litigation that is seeking to withdraw mifepristone from the marketplace — an action that would work severe harm to all who rely on the medication,” Associate Attorney General Vanita Gupta, who chairs the reproductive task force, had said in January, as per The Washington Post.
The many impacts of the Texas verdict
Kacsmaryk was appointed by former US president Donald Trump and is known for his anti-abortion and conservative views.
Abortion rights advocates say if he rules in favour of anti-abortion groups, the result would be “catastrophic”, with further limiting abortion access in the US.
It will also have far-reaching consequences for states where abortion is still legal and not just those that want to restrict the procedure, noted The New York Times (NYT).
It could lead to mifepristone being removed from the market in all 50 states.
If this happens, NARAL Pro-Choice America estimates that 64.5 million American women would lose access to medication abortion care, reported Time magazine.
While some blue states continue to protect access to abortion, legal experts say they do not protect any “particular form of abortion”.
Fearing the worst-case scenario, some providers say if mifepristone goes off the market, then they would have to prescribe only misoprostol for medication abortion.
Speaking to The Washington Post, Amy Hagstrom Miller, chief executive of Whole Woman’s Health, said if Texas bans mifepristone, it could trigger “a huge amount of congestion and waiting” at abortion clinics as more pregnant people would have to depend on surgical procedures.
There is little legal precedent for a single judge to overturn decades-old FDA approval.
If Kacsmaryk grants the preliminary injunction, it would be appealed by the Justice Department at the conservative US Court of Appeals for the 5th Circuit, and could eventually reach the Supreme Court.
With inputs from agencies
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