The abortion drug mifepristone barely escaped the fate of losing its FDA approval – but it’s not over yet. Read here why this case remains worrying.
One can’t help but shake their head and wonder what the hell is going on in the United States. A little more than two weeks ago, a single rogue judge decided to suspend the US Food and Drug Administration’s approval of the abortion inducing drug mifepristone and set in motion a dramatic legal battle that not only endangered reproductive care all over the nation – but American drug safety as a whole.
So, what happened? Bone of contention is a case brought forward by a Christian conservative legal advocacy group in a Texan court. The anti-abortion activists seek to ban mifepristone on a federal level, claiming that the FDA exceeded their regulatory authority and ignored safety concerns when they approved the drug back in 2000. They claim that by easing some restrictions since 2016 (namely extending the gestational window during which the drug can be used to 10 weeks and allowing the drug to be dispensed via mail) the agency put women at risk. In a pretty bizarre move, they furthermore accuse the FDA of having violated federal law by allowing abortion drugs to be distributed via mail – referring to the Comstock Act, a long-forgotten 19th century law that forbade sending “obscene, lewd or lascivious” items like abortifacients and pornography through the mail.
Despite these claims being untenable – decades of worldwide research and close monitoring demonstrate that the drug is safe to use – Texas federal judge Matthew Kacsmaryk did indeed suspend the FDA approval. Not altogether surprising, as this particular judge has never made a secret out of his personal anti-abortion stance. The Biden administration immediately intervened and an appeals court blocked the full suspension. However, the court decided to reinstate the restrictions to mifepristone access that had been in place before 2016, limiting the use to 7 weeks of pregnancy and requiring in-person dispensing.
Following another appeal by the US justice department the case moved up to the supreme court – the very same supreme court that overturned the constitutional right to abortions in the US last year. Fortunately, the court decided on Friday to block Kacsmaryk’s ruling and the newly imposed restrictions, while the case returns to the appeals court. In clear terms: Mifepristone remains available as before – for now. It seems likely that the case will land before America’s highest court again.
The reaction to the original court ruling has been an overwhelming outcry of concern by politicians, legal experts, patient advocates and medical professionals alike. Since the overturning of Roe v. Wade last year, several US states have already banned or at least severely restricted abortions. Such a national ban of abortion drugs would have impacted reproductive care even further, also in states were abortion remains legal.
The progesterone antagonist Mifepristone is used as part of a two-drug regiment to induce abortions together with misoprostol. Misoprostol induces cramping and bleeding and can, in principle, be used without mifepristone to end a pregnancy – something doctors might be forced to do if mifepristone were pulled from the market entirely. However, the misoprostol-only approach has a lower rate of effectiveness (88 %) than the combination (98 %) and has more complicated side-effects and need for follow-up care. More patients would need to undergo surgical abortions if pills became unavailable, which would require more time and resources.
But there’s more to this story than “just another” attack on women’s health and right to choose: drug development and public access to safe medications as a whole was on the line – and still is, as the case isn’t closed yet. For the first time in US history a judge, a person with no expertise on drug safety, chose to ignore the FDA’s thorough and scientifically sound opinion to intervene and overturn a drug’s approval based on personal, political opinion. If upheld by the supreme court, this decision would set a truly worrying precedent. President of the United States Joe Biden commented: “If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.”
In an open letter more than 250 pharmaceutical and biomedical companies point out that arbitrary judicial orders like this could significantly upend the approval process as well as drug development. “If courts can overturn drug approvals without regard for science and evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone.” Any drug development or approval process could be stopped in its tracks on a whim. In an editorial in Science, former commissioner Margaret Hamburg and former principal deputy commissioner of the FDA Joshua Sharfstein second this: “Once courts dismiss core scientific judgements by the agency there is no reason to believe they will limit themselves to this one medication.”
Their worry is not without base: We all have witnessed how medicine can be politicized and become an ideological battleground detached from scientific evidence in the past three years. Mifepristone would be just the beginning, vaccines against COVID-19 and measles might be next. Hamburg and Sharfstein point out that political pressure is forming against antidepressants and cell-derived therapies as well – the list could probably be continued; there’s a fringe opinion to found for anything, really.
In conclusion one can only hope that the courts involved won’t let their political opinions cloud their judicial objectivity as the case continues to be battled in the lower courts. While Friday’s supreme court ruling is a victory for both women’s rights and scientific integrity, it does not affect how the case will be ultimately decided further down the road. “This is very welcome news, but it’s frightening to think that Americans came within hours of losing access to a medication that is used in most abortions in this country and has been used for decades by millions of people to safely end a pregnancy or treat a miscarriage,” said Jennifer Dalven, director of the Reproductive Freedom Project at the American Civil Liberties Union. “Make no mistake, we aren’t out of the woods by any means. This case, which should have been laughed out of court from the very start, will continue on.”
Image source: frank mckenna, Unsplash
