Controversial court rulings in Texas and Washington state could limit access to the widely-used abortion pill, mifepristone, for millions of women. The pill, which has been allowed for over 20 years, is used in most abortions. But a Trump-appointed federal judge in Texas has ordered a hold on its longstanding approval, arguing that the Food and Drug Administration (FDA) approval had violated federal rules that allow for accelerated approval of certain drugs. The judge also said the FDA had failed to consider the “psychological effects” of mifepristone.
The ruling has been criticised by legal analysts, who say it threatens to upend the entire foundation of America’s drug regulatory system. In response, an Obama-appointed judge in Washington state issued a competing injunction, ordering that no change be made to mifepristone’s availability. With duelling court orders in place, the issue is likely to escalate to the US Supreme Court.
The Texas ruling comes after the Supreme Court removed constitutional protections for abortion last year, triggering a wave of state-by-state bans. A lawsuit filed by an anti-abortion group in Texas argued that the drug’s safety was never properly studied. The Alliance Defending Freedom, the group behind the lawsuit, called the Texas ruling “a significant victory” for women and doctors. Jeanne Mancini, president of another anti-abortion group, March for Life, hailed it as “a major step forward for women and girls”.
However, the competing injunction issued in Washington state protects access to the drug for the 18 Democratic-run states that brought the lawsuit. Washington Attorney General Bob Ferguson called the counter-ruling a “huge win…protecting access for the 18 plaintiff states”.
Mifepristone is part of a two-drug regimen that induces abortions, effectively stopping the pregnancy. The second drug, misoprostol, empties the uterus. It was first approved for the termination of pregnancy up until seven weeks gestation, and in 2016, its approved use was extended to 10 weeks of pregnancy. Mifepristone is also used to treat women who have suffered miscarriages and Cushing syndrome, a hormone-related condition.
The FDA, the American College of Obstetrics and Gynaecologists (ACOG), and other mainstream medical organisations say both mifepristone and misoprostol are safe for use. The Texas ruling could limit access to the drug for millions of women and legal analysts fear that this could set a dangerous precedent for America’s drug regulatory system. The Department of Justice has confirmed it will appeal against the Texas ruling.