…Researched and contributed by Henry George for TDPel Media
The US Supreme Court issued a temporary block on a lower court’s order that sought to ban the abortion pill, mifepristone.
As a result, the drug remains available and legal under current regulations until the case progresses through the appeals process, which could take months.
Impact on Reproductive Rights
The ruling on this case could be the most consequential decision on reproductive rights since Roe v Wade was overturned by the Supreme Court in June 2022.
Background on Mifepristone
The FDA approved the use of mifepristone in 2000.
It is the first of two doses in a medication abortion, which accounts for over half of all abortions in the US.
However, 15 states already have limited access to medication abortion.
Court Ruling and Plaintiffs
On April 7, Judge Matthew Kacsmaryk of the Northern District of Texas issued a ruling to rescind the pill’s FDA approval nationwide.
The plaintiffs in the case, anti-abortion doctors, argued that the drug is unsafe and that the FDA’s authorization was improper because pregnancy is not an illness.
However, the drug has a long track record of safety, and a comprehensive review conducted by the National Academies of Sciences confirmed that it has a very low rate of serious complications.
Partial Block by Fifth Circuit Court of Appeals
The following week, the Fifth Circuit Court of Appeals partially blocked Kacsmaryk’s decision, allowing the pill to keep its FDA approval but rolling back several changes that the agency made in recent years to expand access to it.
These changes included pandemic-era provisions that made it easier to prescribe and distribute the pill remotely and a 2016 change that extended the period for taking the pill up to the tenth week of pregnancy.
Department of Justice and Danco Laboratories Intervention
The US Department of Justice and Danco Laboratories, the manufacturer of mifepristone, asked the Supreme Court to intervene.
Over the past week, the court issued two short-term holds as it considered the matter. The court had given itself a deadline of Wednesday by midnight to decide whether the pill would face tighter rules while an appeal moved forward, but it extended the deadline to Friday.
GenBioPro Lawsuit
The manufacturer of a generic form of mifepristone, GenBioPro, filed a lawsuit against the FDA this week.
If mifepristone’s approval is revoked, the generic version would also be suspended.
The company alleges that if the FDA complies with Kacsmaryk’s ruling, it would violate the established legal process for withdrawing a previously-approved drug from use.
Commentary
The block on the ban of mifepristone by the Supreme Court is a win for reproductive rights advocates.
The drug is a critical component of medication abortion and is used in over half of all abortions in the US.
The attempts by anti-abortion doctors to remove the FDA approval of the drug are not based on scientific evidence but rather on ideology. The potential consequences of this ruling extend beyond abortion rights and could impact the FDA’s ability to regulate drugs.
The intervention of pharmaceutical and biotech companies is an indication of the concern this case has generated among industry players.
The temporary block on the ban maintains the status quo until the appeals process is complete, which could take months.