The Supreme Court is set to make a decision on a case involving access to the abortion pill Mifeprex (mifepristone). The case originated from a Texas judge's ruling last year, which suspended the FDA's approval of the abortion pill based on two now-retracted studies claiming harms caused by the pill. These studies were recently retracted due to methodological flaws and undisclosed conflicts of interest.
The lead author of the studies, James Studnicki, denies any wrongdoing and rejects what he considers "baseless attacks" on the scientific research conducted by the Charlotte Lozier Institute, where he serves as vice president. Based on the findings from these retracted publications, Judge Matthew Kacsmaryk argued that the FDA's original approval of mifepristone in 2000 was flawed and suspended its approval, despite the drug being on the market for over two decades.
The judge's decision threatened access to the pill nationwide, but the Supreme Court subsequently blocked the order, maintaining the status quo until it reviews the case next month. The Biden Administration and the manufacturer of the branded version of mifepristone, Mifeprex, have appealed the ruling and are asking for a reversal.
Mifepristone, when used in conjunction with misoprostol, is approved by the FDA for medication abortion. The drug has been in use in Europe for nearly three decades with a minimal number of adverse events, and it has had a similar safety record in the US since its approval. However, some legislators and governors in Republican-led states argue that they can ban abortion drugs based on their authority to regulate the practice of medicine, even if it goes against the FDA's decisions.
While the Supreme Court will decide on access to mifepristone, there is an ongoing issue of states defying the FDA's authority and imposing restrictions on the drug. These restrictions are often justified under the guise of preventing medical risks, but they are often based on anti-abortion beliefs. It remains to be seen how the Supreme Court's decision will impact access to mifepristone, but it is clear that the issue of state restrictions will persist.