The US Justice Department has announced its intention to challenge an appeals court ruling that restricted access to the abortion pill mifepristone. The case centres on a lawsuit filed against the Food and Drug Administration by anti-abortion groups which argues that the medication is unsafe and was approved without adequate scientific evaluation. The three-judge panel from the US Court of Appeals for the Fifth Circuit ruled that mifepristone should remain available while the lawsuit proceeds through the courts but also overturned several recent measures that expanded access to the pill. These included allowing it to be sent by mail and prescribed by some healthcare providers who are not doctors.
The Justice Department said it would appeal to the Supreme Court and defend the FDA’s scientific judgment. Danco Laboratories, which makes Mifeprex, the brand-name version of mifepristone, will also petition the court for emergency relief. The plaintiffs argue that mifepristone causes “cramping, heavy bleeding and severe pain,” and the FDA has ignored safety risks and never adequately evaluated the scientific evidence. The FDA and mainstream medical organizations dispute this claim and point to years of scientific studies that show that serious complications are rare. The medication is used in more than half of pregnancy terminations in the US.
The case has attracted widespread interest, with more than 400 pharmaceutical industry leaders and investors issuing a statement condemning the ruling and demanding that it be reversed. They argue that leaving the fate of medicines in the hands of jurists would have a chilling effect on drug development in the US, reducing incentives for investment and innovation. The case also has national implications for abortion access, with the ruling restricting access to the pill in several states. The appeals court opinion appeared to accept several of the claims of the anti-abortion plaintiffs, referring to medication abortion as “chemical abortion” and in one instance referring to a fetus or embryo as “an unborn child”.