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Federal court suspends FDA approval of abortion pill

President Biden announced that the Department of Justice has appealed the ruling and called the ruling "an ideological attack."

A pregnant woman holds pills in her hand.

(Unsplash)

Published by
Israel Duro

Amarillo (North Texas) District Judge Matthew Kacsmaryk suspended the Food and Drug Administration's (FDA) approval of mifepristone from the year 2000. The ruling, which was immediately appealed by the Biden Administration, will force the sale of the abortion pill to be halted nationwide. President Biden and the Department of Justice issued statements criticizing the ruling, which they called an "ideological attack" for "endangering" women's health.

Several pro-life and medical associations, including the Alliance for Hippocratic Medicine, the Alliance Defending Freedom and Students for Life, filed a joint lawsuit arguing that the FDA mistakingly determined the abortion drug to be safe and efficient. They also pointed out that the approval process fraudulently used a federal rule that allows certain drugs that treat "serious or life-threatening diseases" to get expedited clearance from the agency. In addition, the plaintiffs allege that the FDA overstepped its regulatory authority in approving mifepristone and asked the judge to issue a preliminary injunction ordering the FDA to undo its approval of the drug.

"Political pressure" on FDA to approve abortion pill

In the sentence, the judge pointed out that the "FDA manipulated and misconstrued the text of Subpart H to greenlight elective chemical abortions on a wide scale." In addition, "the FDA has blocked from judicial review so far," and accused the agency of ignoring petitions against the approval of mifepristone for 16 years. Kacsmaryk also criticized the way the agency made its decision and condemned the political pressures to which the FDA was subjected "in order to waive your safety precautions."

The court does not second-guess FDA's decision-making lightly. But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions. There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased 'access; to chemical abortion — which was the 'whole idea of mifepristone.

"A significant victory for physicians"

Alliance Defending Freedom claimed that the ruling is "a significant victory for the doctors and medical associations we represent and, more importantly, for the health and safety of women and girls." The president of Students for Life, Kristan Hawkins, stated that "U.S. District Judge Matthew Kacsmaryk’s lifesaving injunction is what the country needs because the Biden Administration’s No Test, Online distribution scheme for Chemicals Abortion exposes women to injury, infertility, death, and abusers who use the drugs against mothers without their knowledge or consent."

Tough statement from the White House

As soon as the ruling was finalized, the White House issued a statement from President Biden accusing the judge of imposing his ideological criteria on that of the FDA, setting a dangerous precedent:

The court in this case has substituted its judgment for FDA, the expert agency that approves drugs. If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks. The prescription medication in question in this case is used for medication abortion, and medication abortion accounts for over half the abortions in America.  The lawsuit, and this ruling, is another unprecedented step in taking away basic freedoms from women and putting their health at risk.

DOJ appealed the suspension immediately

In the same statement, the president mentioned that the Department of Justice appealed the lawsuit as soon as it was notified of the ruling. In addition, Biden claimed that the only way to "protect a woman's right to abortion" is for voters to elect "a Congress that will pass a law that reinstates Roe v. Wade."

My Administration will fight this ruling.  The Department of Justice has already filed an appeal and will seek an immediate stay of the decision.  But let’s be clear – the only way to stop those who are committed to taking away women’s rights and freedoms in every state is to elect a Congress who will pass a law restoring Roe versus Wade.  Vice President Harris and I will continue to lead the fight to protect a woman’s right to an abortion, and to make her own decisions about her own health.  That is our commitment.
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