Texas Judge Rescinds FDA Approval of Abortion Drug Unless Appealed

UPDATE: Appeals Court Keeps Abortion Pills on Market but Tightens FDA Restrictions

A Texas judge rescinded FDA approval today of the abortion-inducing drug mifepristone. In seven days, the ruling will block the distribution of the abortion-inducing drug nationwide unless the decision is appealed.

Federal District Judge Matthew Kacsmaryk of the Northern District of Texas ruled today that the FDA failed to follow proper protocol and neglected its duty during the initial approval and subsequent changes to the rules for using mifepristone to end the lives of preborn children.

The U.S. Food and Drug Administration (FDA) approved a regimen in 2000 for chemical abortion, with mifepristone as the first drug in the process and misoprostol as the second. Mifepristone kills the preborn child by starving him or her to death, and misoprostol expels the deceased baby. Chemical abortions are committed early in pregnancies and have become the primary procedure for abortion nationally.

“The FDA exists to protect Americans from dangerous drugs, yet it repeatedly ignored its legislative purpose in order to promote elective abortion at the expense of pregnant women and their preborn children,” Texas Right to Life President Dr. John Seago responded.

Four national medical associations, four doctors, and Alliance Defending Freedom filed the lawsuit against the FDA, asserting the agency overstepped its authority, first in approving the two-step abortion process, and again in loosening safeguards on the procedure.

In today’s ruling, Kacsmaryk also criticized the FDA’s repeated efforts in the last 20 years to waive safety guidelines and protective measures. In 2016, the administration approved the abortion pills for use later in pregnancy, from seven weeks to 10 weeks, despite the increased risk of complications. In 2021, the FDA removed the requirement for pregnant women to visit a doctor in person in order to determine the age of the preborn child and examine the mother for ectopic pregnancy, Rh incompatibility, or other conditions that contraindicate the abortion pill regimen.

Every abortion ends the life of the innocent preborn child, but chemical abortion is additionally dangerous for the pregnant mother. Studies show that 1 in 5 women experience an adverse event following a chemical abortion, the rate of complications for chemical abortions are four times higher than surgical abortions, and they require follow-up surgical abortion in 3-8% of cases. This type of abortion takes much longer and involves more bleeding and pain, and complications increase exponentially with the baby’s increasing gestational age. 

With this ruling, Judge Kacsmaryk correctly deemed that the FDA overstepped its regulatory authority.

While the decision does not change the status quo in Pro-Life states like Texas, if the ruling stands after appeal, it could save lives in other states by effectively removing mifepristone from the market when used for elective abortion.

Doctors, however, should not be concerned about changing their protocol for treating miscarriages or ectopic pregnancies. This lawsuit does not ask the court to take mifepristone off the market for all purposes. Thus, the ruling can only apply to chemical abortions. While miscarriage treatment can indeed involve similar drugs and procedures as elective abortion, removing a deceased child who passed away by spontaneous miscarriage is legally and morally different than intentionally ending that child’s life, and it is therefore not defined as an abortion. 

Pro-Life laws in every state contain exceptions for instances in which the life of the mother is threatened. The law requires that the threat be foreseeable and doctors therefore may act within their reasonable medical judgment as soon as the threat is identified. Pro-Life policies do not require physicians to delay necessary care until the danger is imminent in order to treat a mother.

Today’s ruling will likely be appealed to the United States Court of Appeals for the Fifth Circuit and then to the Supreme Court. Judges will evaluate whether the FDA applied different standards for chemical abortions than it would for other drugs.

In the meantime, Texas Right to Life applauds this decision and is optimistic that lives will be saved through Judge Kacsmaryk’s ruling.

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