This article explores the role of the Food and Drug Administration (FDA) in drug approval and restrictions to mifepristone access in the context of historical regulation and current litigation.

Legal challenges to the FDA’s approval of mifepristone have destabilized patients’ ability to access controversial medicines like medication abortion. We argue that federal courts’ receptiveness to this litigation undermines the coherence and integrity of prescription drug regulation in the U.S.

The Supreme Court decided Box v. Planned Parenthood of Indiana and Kentucky in 2019. Justice Clarence Thomas’s opinion in the case claimed there was a direct connection between the legalization of abortion, in the late 20th Century, and the beginnings of the birth control movement a full three quarters of a century earlier. “Many eugenicists,” Thomas argued, “supported legalizing abortion.”Justice Samuel Alito highlighted similar claims in Dobbs v. Jackson Women’s Health, citing a brief entitled “The Eugenic Era Lives on through (...) the Abortion Movement.” That brief was an echo of Justice Thomas’ misguided attempt at history in the Box opinion. Similar claims reoccur in Judge Matthew Kacsmaryk’s opinion in the Texas mifepristone case, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration.These false claims are the focus of this article. There is no evidence that early leaders of the eugenics movement supported abortion as part of the movement for birth control. It is accurate to describe those leaders as anti-abortion, and their followers as people who condemned abortion for moral, legal, and medical reasons. (shrink)

After the US Supreme Court’s reversal of Roe v. Wade, a number of states have immediately banned abortion. Pro-choice activists are responding by promoting medication abortions – a do-it-yourself form of abortion. Women can take pills at home to induce an abortion in the first few weeks of pregnancy. -/- The Biden Administration [1] has backed the abortion pill, too. Attorney-General Merrick B. Garland and Health and Human Services Secretary Xavier Becerra both issued statements endorsing it. -/- “We stand ready (...) to work with other arms of the federal government that seek to use their lawful authorities to protect and preserve access to reproductive care,” said the Attorney-General. “In particular, the F.D.A. has approved the use of the medication mifepristone. States may not ban mifepristone based on disagreement with the F.D.A.’s expert judgment about its safety and efficacy.” -/- As the New York Times [1] has noted, this sets the scene for legal battles. The obvious one is: will anti-abortion states prosecute medication abortions? -/- But – based on experience in the United Kingdom - the use of the abortion pill could give pro-life doctors headaches as well. -/- In the past year, UK has witnessed the saga of two Catholic doctors who have been brought in front of the professional regulator, the General Medical Council, after accusations of professional misconduct. Their crime? They had supplied abortion pill reversal (APR) treatment to women. Accusations of this misconduct have been brought forward by pro-choice organisations [2]. -/- The problem is that some women might panic when they discover that they are pregnant or are pressured to make a rash decision. They obtain abortion pills, often without seeing a doctor faceto- face, and soon after taking the first pill, they regret their decision. -/- Is it too late for them to save their pregnancy? Not necessarily. -/- A treatment developed in the US works about half the time. It involves the woman taking progesterone after the first abortion pill to counteract the abortifacient action of the drug. -/- Seventy-three women in the UK are reported to have taken a full APR course, of whom, 38 – more than half — successfully remained pregnant. Admittedly, the procedure is controversial [3], with pro-choice writers denouncing it as unproven, unscientific, and unethical. This has triggered some healthcare practitioners and scholars to analyse the commitments of the pro-choice movement to APR. In a recently published paper in The New Bioethics [4], two colleagues, Dominic Whitehouse and Steven Bow, and I argue that those espousing a pro-choice worldview should actually support abortion pill reversal and that the current evidence indicates that they should actually be doing it. -/- While some pro-choice activists might be happy simply to expand women’s reproductive choices, some might also want to ensure that these choices are safe and effective at achieving the desired outcome, which in principle includes maintaining a pregnancy. -/- We then review the scientific evidence with respect to the ability of APR to halt an abortion, look at the potential impact of APR on mental health, as well as its procedural safety. While highlighting that gold-standard evidence is lacking, we note that APR is associated with about two times higher rate of embryo survival compared to not completing the full early medical abortion course, that there is large agreement in the literature that women who are ambiguous about abortion are at risk of poorer mental health outcomes after abortion (and argue that women who request APR fall into this category), and highlight that there is no evidence that APR is more dangerous than abandoning an initiated early medical abortion. -/- The latter fact is important, as the results of the only randomised-controlled trial of APR have been at times misrepresented in the media [5.6], creating the impression that APR is not safe while most of the adverse effects occurred in the study group that did not receive APR. As our paper argues, with respect to APR the two UK doctors were “champions of women’s choice and should be congratulated, not condemned, by pro-choice advocates”. -/- While the cases against the two doctors have now been dropped (and there have even been accusations against a member of one of these pro-choice organisations that they pressurised a patient into complaining about one of the doctors and twisted the patient’s experience of the treatment [7]), we argue that it is important to set-up systems to facilitate the future provision of APR to protect both patients and healthcare staff. -/- Our conclusion is that, while being open to any change in evidence, those espousing a pro-choice outlook should “support calls for an APR framework that will protect women and the healthcare professionals caring for them” “and certainly not oppose” APR. -/- The debate over abortion pill reversal will be heading to the United States soon. It is quite possible that it will be denounced as dangerous misinformation. It’s not. But pro-life defenders should be prepared to defend their ground. -/- This article was first published by Mercatornet. (shrink)

Between 1983 and 1990, at least 163 Western drugs were tested in the GDR. On the basis of archival documentation, relevant literature, and interviews we examined the clinical trials of five drugs more thoroughly; two of these individual case studies are introduced in this article. In the case of the clinical trials of the synthetic human growth hormone Saizen we found extensive trial and patient documentation, which allows for a detailed analysis of ethical aspects such as parent information and informed (...) patient consent. In the case of the clinical trials of the „abortion pill“ Mifepristone for the World Health Organization we uncovered irregularities with regard to the ethical evaluation. However, taken together, we could not find any serious violation of ethical norms in connection with our cases studies. (shrink)

Jansen expresses concern as to the legal implications of both selective reduction of pregnancy and unsuccessful attempts at termination of pregnancy using mifepristone. This commentary examines the legality of both procedures and concludes that Jansen is over-optimistic in his belief that neither procedure is likely to fall foul of the criminal laws on induced abortion. By contrast his anxieties about civil liability arising from the subsequent live birth of a damaged infant are, it is suggested, unnecessarily pessimistic. Such an (...) action is most unlikely to succeed if brought by the infant herself and any claim on the part of the mother will normally be dependent on proof of negligence. The commentary focusses on the law in England with relevant references to other common law jurisdictions. (shrink)

In England, Wales and Scotland, the vast majority of abortions take place in the first trimester of pregnancy. In 2009, for example, 91% of abortions were carried out at under 13 weeks gestation for women resident in England and Wales. 1 Early abortion opens up the opportunity for a woman to have a medical abortion rather than a surgical abortion. Medical abortion is considered to be less invasive and less expensive than surgical abortion, and is increasingly becoming the preferred method. (...) 1 The proportion of medical abortions to surgical abortions has doubled in the last five years with 52% of abortions being medical abortions under 9 weeks gestation in 2009. A medical abortion typically involves taking mifepristone to block the hormones that help a pregnancy to continue, and then later on misoprostol, which makes the womb expel the embryo/fetus, usually within 4–6 h. Current legislation requires that both sets of drugs are administered in an NHS hospital or approved place, but women can go home after taking the second dose of drugs to complete the abortion. There has long been disagreement between the Department of Health and the British Pregnancy Advisory Services about what constitutes ‘any treatment for the termination of pregnancy’ under the Abortion Act 1967, specifically whether a woman taking the second set of drugs is considered to be undergoing the ‘treatment’ and is therefore required to be present in premises permitted under the Act. At the end of 2010, BPAS went to the High Court to challenge the Department of Health's view that the legislation requires women to take both sets of drugs in an approved place. BPAS argued that ‘treatment’ stops at the point of prescription and women should be able to go home, …. (shrink)