The Supreme Court of the United States overturned Roe v. Wade in its ruling on Dobbs v. Jackson Women’s Health Organization, which returned abortion policy decisions to individual state legislatures. The end result has been a near abortion ban in 13 states.
After the ruling, abortion rights advocates filed suits attempting to block the bans and scrambled to champion non-traditional avenues for women in these states to continue accessing abortion related services. One avenue was to ensure patients nationwide could continue to access the drugs mifepristone and misoprostol, the two primary abortion drugs in the U.S.
On November 18, 2022, the Alliance for Hippocratic Medicine, a group of physicians opposed to abortion, filed suit in order to overturn mifepristone’s Food and Drug Administration approval.
Their basic argument is that 23 years ago, the FDA did not follow its own internal rules and protocol in approving mifepristone as part of a two-drug regiment for the termination of pregnancy.
This is a significant accusation which challenges the integrity of our drug approval process. While the accusation should be taken seriously, we must remember that the approval was granted two and a half decades ago.
The alliance’s approach to seek restrictions on abortion medications might be shrewd legal maneuvering but it is also deceitful, as mifepristone and misoprostol have had FDA approval since 2000 and 1988, respectively, and have been used successfully and safely in over five million cases of induced abortions over the last three decades.
In short, the drugs have gone way beyond the burden of the FDA approval process and have proven to be effective and safe for the mother. So even if the FDA did not follow the prescribed approval process, the evidence is already out there making the alliance’s legal argument pointless.
On April 7, Trump-appointed Judge Matthew J. Kacsmaryk ordered a stay of the FDA approval of mifepristone to take effect in seven days. Five days later, the U.S. Fifth Circuit Court of Appeals suspended part of the lower courts initial stay.
In addition, the appeals court ruled that the drug could continue to be available but only for the first seven weeks of pregnancy (when many women do not yet realize they are pregnant), and could not be mailed or dispensed in its generic form. Mifepristone’s generic form accounts for two-thirds of the supply of such drugs.
Apparently wanting more than the victory handed to them by the Fifth Circuit, the plaintiffs immediately filed an appeal to overturn the appellate court’s ruling.
On April 19, SCOTUS extended the deadline two days, and on April 21, it issued a 7-2 ruling, freezing the lower court ruling and allowing the drugs to remain available without additional restrictions. This decision sent the case back to the lower courts.
Abortion supporters had previously spoken out against the lower court and appellate court’s decisions, as either would greatly limit access to abortions for women living in many states.
There is more at stake here than abortion. The case has brought up questions related to judicial authority over the FDA and the process for the approval of drugs. In addition, it places justices in the position of making medical decisions.
Last week, Vice President Kamala Harris warned that the ruling was dangerous, arguing: “You can understand the implications of this ruling by just opening your medicine cabinet. … It is very likely that you rely on some type of medication, prescribed by a doctor, approved by the FDA, to alleviate your health concerns and improve your condition in life.”
This case has the potential to impact the process that ensures those drugs are safe. At a minimum, if mifepristone loses its FDA approval it will impact more than just women seeking abortions, as the drug is commonly used after a miscarriage and to block an excess production of cortisol in women.
While the drug is used in a different dosage and marketed differently, it is also used in the treatment of Cushing syndrome. In addition, the drug has several off-label obstetric and gynecological uses, and it is currently being used through the Compassionate Use Program in cancer and depression drug trials.
Beyond that, the ruling is a significant challenge to our nation’s drug approval and regulatory system. If the FDA is forced to revoke mifepristone’s status, then it will open a flood gate of challenges to existing drugs which have been on the market for decades.
This would also set a precedent that would place judges, most of whom did not go to medical school, in a dangerous position of authority outside their scope of practice. Judges would be supervising the drug approval process instead of doctors and scientists.
If the FDA did not follow the official process for approving mifepristone, then that needs to be investigated and prevented from happening again in order to ensure the integrity of the system. However, allowing a judge to make decisions about the nation’s drug approval process to the point of determining which drugs can stay on the shelf is not the solution.
Finally, such a move would create an open season on any politically or morally charged medication, ranging from hormonal birth control and HIV medications to vaccines and cancer drugs. All one would need to do is find a sympathetic judge and bring a case to have the drug removed from the market based on personal views about the medication.
The litigation alone would shut down the FDA approval system, preventing any new medications from coming to market. The new level of approval complexity would likely discourage the pharmaceutical industry from investing in new medication research or, even worse, move the industry overseas.
Regardless of one’s position on the moral permissibility of abortion or a woman’s right to choose what she wants to do with her body, this case needs to be reconsidered. If it isn’t, then the U.S. court system will probably become flooded with cases related to moral politics which in the end will only make matters worse.
Senior Staff Chaplain and Clinical Ethicist at the Baptist Health Medical Center in Little Rock, Arkansas.