On Friday, April 7, 2023, a federal district court in Texas issued a decision that, if sustained, would invalidate the approval of mifepristone, a medication approved in 2000 by the US Food and Drug Administration (FDA) for prescription use in the United States, and which is used in conjunction with misoprostol to induce a medication abortion (the judge stayed his own order for seven days). A judge in Washington State has issued a countervailing order blocking the enforcement of the Texas court, and there will likely be more legal maneuverings over the coming days.
But let’s be clear. The Texas court’s decision represents an unprecedented attack on the role of science, regulatory authority, personal freedom, and reproductive health. No medication has ever been removed from the market over the scientific objections of the Food and Drug Administration. Even if this were a legitimate pathway to regulate products, the data and evidence establishing mifepristone as a safe and effective method for terminating a pregnancy has only been further strengthened in the 20+ years since its FDA approval, which was obtained by the Population Council after we conducted clinical trials to evaluate the use of mifepristone. The medication continues to have a remarkably safe track record — and has been safely used by millions of individuals seeking to end a pregnancy in the United States and around the world.
The real agenda of the plaintiffs of this lawsuit is to oppose the right to decide whether or not to have an abortion. The Population Council firmly asserts that safe abortion care is a part of comprehensive sexual and reproductive health. Restricting access to safe abortion threatens people’s autonomy, agency, and health. In addition to the obvious lack of standing of these plaintiffs in this case, the false statements made regarding the FDA review process (which, in reality, was careful and thorough), should have been summarily rejected by the District Court, whose verdict was properly countermanded by the Washington State Court and should be summarily rejected upon appeal.
The FDA’s role is to regulate medications in the United States, and their evaluations should be based on the scientific evidence of the safety and efficacy of the medications. Mifepristone should not be singled out because of the views of a subset of people who do not support its use for abortion. In addition, this Texas ruling, if enforced, could also affect another use of mifepristone – to help manage miscarriages.
Evidence from around the world consistently shows that making abortion less accessible increases unsafe abortion and maternal disability and death. It is unconscionable to inject political aims into the drug regulation process, particularly when the lives and health of so many people will be compromised. The Population Council condemns this effort in the strongest possible terms and will steadfastly continue our mission toward ensuring sexual and reproductive health, rights and choices for everyone, everywhere.