Hearings began last week on a reproductive health lawsuit that has wide-reaching implications for the FDA’s drug approval process. Mifepristone, the first part of a two-drug regimen to induce an abortion, is under attack by anti-abortion activists who claim the drug was not proven safe nor properly regulated during the past two decades its been prescribed.
Mifepristone is safe
Mifepristone is a safe and effective drug to take when inducing abortion and miscarriage. It has been repeatedly scrutinized over its two decades on the American drug market (it’s been approved in Europe since the 1980s) and has time and time again been found to be effective and safe. A robust analysis of over 11,000 patients in California found a 0.31% major complication rate, and another systematic review of over 45,000 patients had similar findings. This is significantly lower than the complication rates of other drugs the FDA has approved. With Aduhelm, for example, around 40% of patients experienced dangerous side effects.
Mifepristone is typically part of a two-drug regimen for medication abortion, alongside the drug misoprostol. While misoprostol on its own works as an abortifacient, research has shown that it is more effective and causes fewer side effects when taken alongside mifepristone.
What’s behind the lawsuit
The plaintiffs argue that the FDA fast-tracked approval of mifepristone and has not sufficiently tracked adverse events and thus, its approval should be rescinded. The government asserts that mifepristone’s approval occurred four years after the application and did not involve an official accelerated review. A core part of the lawsuit is the Administrative Procedures Act Subpart H. The plaintiffs say the FDA had no right to utilize subpart H; the FDA firmly disagrees, arguing subpart H actually helped maintain safety by restricting the manufacturer’s distribution of mifepristone. In 2011 the FDA implemented a Risk Evaluation and Mitigation Strategy (REMS) to the dispensing requirements as an extra safety measure. The plaintiffs also argue that although they are not abortion providers, mifepristone patients experiencing complications will take up so much of their time and energy and detract from other patients’ care, despite the demonstrated low complication rate.
Regulatory chaos
If Judge Kacsmaryk rules in favor of the plaintiffs, this could open the door to drug regulatory chaos. Currently, the FDA’s process for approving and withdrawing drugs is largely self-contained– their job is to evaluate evidence from clinical trials, convene advisory groups and hold hearings to discuss evidence, and eventually make decisions on whether or not a drug is effective and safe. Drugmakers, outside experts, and patient groups have many opportunities to give their input, but they cannot overrule the FDA’s decision.
The mifepristone case could change all that. The decision could set a precedent for anyone to challenge an FDA approval based on the existence of any adverse events, even in drugs that are overwhelmingly more beneficial than harmful. This would essentially put every drug on the market at risk of withdrawal by a legal challenge– especially those that have become politicized such as hormone treatments or COVID-19 vaccines.
This would also lead to big ripple effects within the drug development pipeline. Why would a pharma company bother to invest millions into research and development for a new drug for birth control or an HPV vaccine if they thought that it might be withdrawn later through a legal challenge?
If millions of patients and decades of research are not enough to support the FDA’s decision, what will be? While the morality of abortion can be debated, the safety of mifepristone is clear. If we start using personal mortality to decide whether or not a drug can be on the market, we should all start hoping there’s nobody out there with a strong moral stance against other safe and effective drugs like ibuprofen.