Lawsuit Challenging FDA’s Approval of Abortion Pill Gains Ground

On April 7, a federal district court in Texas issued an injunction that effectively revokes the Food and Drug Administration’s (FDA) approval of the abortion pill, mifepristone. However, the judge issued a 7-day stay on his order to allow the FDA to seek a further stay from a higher court, the Federal Court of Appeals for the Fifth Circuit. The FDA filed a motion to extend the stay.

Before explaining the case further, it is important to understand how the abortion pill, also called a “chemical abortion,” works. It is actually a regimen of two different drugs. The first, mifepristone, is a synthetic steroid that inhibits the mother’s production of progesterone, a hormone that supports pregnancy. Mifepristone causes the baby in the womb to die. The second drug, misoprostol, stimulates uterine contractions, causing the expulsion of the dead baby from the womb. In this case, the plaintiffs are suing the FDA, claiming that it violated the law in approving mifepristone.

So what does the court’s decision mean? Let’s start from the beginning.

How Did This Case Get To Court?

The Food and Drug Administration is a government agency in the executive department that regulates foods and drugs in the United States. Although its mission is far-reaching, the FDA’s role, in this case, was to approve mifepristone as a “safe and effective” drug for its intended use.

In addition to the safety of the drug itself, the plaintiff in this case, the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), is challenging additional regulations issued by the FDA that have progressively loosened the conditions under which the abortion pill can be prescribed and dispensed. AAPLOG alleges that the FDA’s actions do not comply with the FDA’s core mission. Dr. William Lile, the ProLife Doc, is a member of AAPLOG.

Why is a court reviewing this decision 23 years after the drug’s approval in 2000? It’s a good question. After all, shouldn’t this lawsuit have been brought two decades ago? The answer is yes. But in this case, the plaintiffs had filed petitions with the FDA following regulatory requirements challenging the FDA’s rule back in 2002 and again when new regulations were issued in 2019. Even though the FDA is required by law to respond to petitions within 180 days, the FDA postponed responding to the plaintiff’s petitions repeatedly. The court concluded that the FDA had, by its inaction, delayethe plaintiff’s ability to file suit over the various rules for over 16 years!

There are numerous legal issues in this case, but the upshot of the court’s 67-page opinion is that AAPLOG prevailed on nearly every claim. Pro-abortion advocates are attacking this decision more by smearing the judge than by discussing the issues in the case. But the judge, in the 67-page opinion, exhaustively considered every argument raised by the FDA in this case. 

The FDA Did Not Follow Its Own Rules

One glaring issue is that the FDA used a particular provision of its enabling legislation, referred to as “Subpart H,” that allows the FDA to “fast-track” the approval process for certain drugs. To fall under this provision, a drug must have been “studied for [its] safety and effectiveness in treating serious or life-threatening illnesses.” In other words, the FDA claims that pregnancy is a “serious or life-threatening illness.” 

Other problematic actions taken by the FDA were to loosen restrictions on access to the drug in both 2016 and 2020, despite indications that each of these measures made it more likely that women would suffer adverse effects from the drug. These measures included:

  • Extending the maximum gestational age for use from 7 weeks gestation to 10 weeks gestation
  • Allowing non-physician “healthcare providers” to dispense and administer the drug without an in-person examination for verification of gestational age or the existence of an ectopic pregnancy
  • Lowering the dosage for mifepristone from 600 mg to 200 mg but raising the misoprostol dosage from 400 mcg to 800 mcg
  • Changing the pill regimen to allow women to take the second pill 24 to 48 hours after the first pill instead of 48 hours afterward
  • Eliminating the requirement that misoprostol be given in a clinical setting
  • Removing the requirement of an in-person medical examination after the abortion
  • Eliminating the requirement for prescribers to report all non-fatal adverse events from chemical abortion drugs

The AAPLOG contended that each of these measures resulted in greater risks to their patients. These risks are anything but speculative. The court pointed out some sobering data that the FDA discounted: 

  • Chemical abortion-related emergency room visits increased by over 500% from 2002 to 2015
  • Complications from a chemical abortion occur at a rate of about four times higher than for a surgical abortion
  • 60% of women who suffer complications as a result of a chemical abortion mislead Emergency Room personnel by characterizing their condition as a “miscarriage” rather than complications from a chemical abortion, leading ER physicians to initiate incorrect treatment protocols
  • To date, the FDA has not determined whether using the abortion pill can affect fertility long-term for girls who have not reached full reproductive maturity
  • FDA’s data shows that at least 97 women with ectopic pregnancies were prescribed and took the abortion pill, which is life-threatening

In short, in this case, the court found that the FDA ignored critical aspects of its congressional mandate to ensure that any drug it approves is safe and effective in itself and in how it is administered. Instead, the FDA shepherded mifepristone through its system to reach a predetermined outcome of making the abortion pill easy to access. 

Pro-Life Doc: Fighting for the Pre-Born on Every Front

One of the great things about working for the ProLife Cause is being part of a community of individuals who understand and appreciate the value and beauty of life. As a member of AAPLOG, the group that filed this lawsuit, I have the privilege of helping women and their unborn babies daily. I never tire of or lose my wonder in seeing the miracle of human life take form in the womb and, later, at the moment of birth. 

Every year, there are new medical breakthroughs in treating the unborn for conditions that, at one time, might have been life-threatening or life-limiting. Being part of a profession that saves babies’ lives is a joy. But in this case, there has been a legal breakthrough that could save pre-born babies’ lives. 

For more information about our ministry or to donate, contact Pro-Life Doc today.

UPDATE: On April 12, 2023, the U.S. Court of Appeals for the Fifth Circuit granted a partial stay in the case. The court has upheld that portion of the injunction that prevents the abortion pill from being sent through the mail.

UPDATE: On April 23, 2023, the U.S. Supreme Court, blocked the injunction by the U.S. District Court and remanded the case back to the Fifth Circuit. This action effectively maintains the status quo on the availability and distribution of abortion pill where it is legal.

The Fifth Circuit has scheduled an expedited hearing for May 17, 2023. Neither the Fifth Circuit’s nor the Supreme Court’s orders relate to the merits of the case – that is, they are procedural orders and have no bearing on the issue of whether the FDA acted lawfully in approving the abortion pill or in modifying the means of prescribing or distributing the drug.

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