At M360, we believe that all women should have control over their reproductive healthcare, including abortion and contraception. Since the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization in June of last year, the reproductive health policy landscape has changed profoundly. Women today face drastic new barriers to accessing the full range of reproductive health care, with those who are most disadvantaged and discriminated against, disproportionately harmed.
Until recently, this uncertain and uneven landscape was a state-based problem, with different state governments working to pass laws that either limited or increased access to care. However, as we detail below, a federal judge in Texas ruled in April that the FDA’s approval of mifepristone was unlawful—a decision with the potential to drastically reduce access to critical reproductive care throughout the country. This court case—as well as state governments’ efforts in this space—continues to evolve rapidly.
The Future of Mifepristone Use Remains Uncertain
On April 7, a federal judge in Texas ruled in Alliance for Hippocratic Medicine et al v. U.S. Food and Drug Administration et al that the FDA’s approval of mifepristone was unlawful. Mifepristone—one of two drugs used in medication abortion—has been shown for 20 years to be safe and effective. Alongside contraception, it is part of the full range of reproductive health care that women in this country must have equitable access to ensuring that they have control over their lives and their futures.
On April 12, the Fifth U.S. Circuit Court of Appeals partially pulled back the Texas ruling from the previous week. The court paused the ruling—meaning mifepristone would still be available—but sought to reimpose outdated rules that would restrict access. The Department of Justice (DOJ) and the manufacturer of mifepristone, Danco Laboratories, asked the Supreme Court to intervene.
Medicines360 Signs Amicus Brief Alongside Other Pharma Companies
If the April 7 decision stands, it will diminish the FDA’s authority over drug and device approvals, endangering innovation and ultimately women’s health across the country. Medicines360 was proud to join other leaders in the pharmaceutical industry in filing an amicus brief with the Supreme Court as well as publishing an open-letter on this case.
On April 21, the Supreme Court granted the stay of execution, requested by the DOJ and Danco Laboratories, allowing mifepristone to retain its current FDA approval status as the case proceeds through the Fifth Circuit Court of Appeals. While the threat to unravel women’s rights and the scientific foundation of our drug and device approval process is far from over, it was reassuring to see our nation’s highest court issue a stay of execution on this case. As a result of this stay, mifepristone will remain accessible while the Fifth Circuit hears the appeal. Medicines360 released a statement on this decision.
We will continue to follow this case closely, and continue to work however we can, to stand up for women’s rights and the scientific process. Regardless of any developments in this judicial process, Medicines360 knows that it is critical to shore up efforts to sustain and strengthen sexual and reproductive health care resources; we stand with women—always.
