A legal battle has begun in New Orleans over the Food and Drug Administration’s 2000 approval of mifepristone, a drug used in the most common method of abortion. The case revolves around the FDA’s approval of mifepristone, which doctors administer along with the hormone progesterone to terminate pregnancies. Anti-abortion groups argue that mifepristone blocks progesterone, which they refer to as a hormone needed for the development of pregnancy. The group aims for the drug’s approval to be reversed.
The lawsuit has faced criticism from various health organizations, which argue that mifepristone has been subject to repeated legal challenges despite being approved by the FDA 21 years ago. The FDA vehemently rejected the criticisms of the drug, meaning the case could have a wider impact on drugs that require FDA approval, as well as online pharmacies.
Fourteen US states have banned abortion at all stages of pregnancy since the Supreme Court overturned the Roe v. Wade ruling, which had established abortion rights, last year. These rulings have been widely debated, with many organizations arguing that they disproportionately affect low-income and rural women.
The Biden administration recently stepped in to appeal a ruling from a Trump-appointed federal judge in Texas that imposed new restrictions on mifepristone. The US Court of Appeals for the Fifth Circuit is currently considering the issue, which means this case is likely to go to the Supreme Court in the future.
Online access to medical abortions has featured heavily in the legal battlegrounds surrounding abortion. A Texas law that would have banned medication-induced abortions was recently blocked by the US Supreme Court, marking its second time in a year considering a major effort to curtail access to abortion. The ruling, which permits mail delivery of mifepristone, could have implications for states where abortion is legal, as well as the FDA’s regulatory authority over other drugs.
The debate around mifepristone comes less than a year after the Supreme Court’s conservative majority overturned Roe v. Wade, allowing more than a dozen states to effectively ban abortion outright. Many providers fear that restrictions on mifepristone will require surgical abortions, leading to a surge in demand on clinics.
Recently, the US Supreme Court temporarily blocked restrictions on mifepristone requested by four anti-abortion groups and supported by the Christian legal group Alliance Defending Freedom, while a full lawsuit targeting the drug continues. The FDA has rejected the group’s criticisms and maintains that the drug has been repeatedly reviewed. A Trump-appointed federal judge had previously suspended the FDA’s approval of mifepristone, issuing a preliminary injunction, which the high court then temporarily blocked.
The US Supreme Court recently ruled to preserve access to mifepristone and reject lower court restrictions in a similar lawsuit administered in Texas late last year. The FDA approved the use of the drug over 20 years ago, and more than five million women have used it to safely terminate pregnancies since. Despite its approval, Texas opponents argue that the FDA’s approval was flawed, leading to further legal battles.
As debates surrounding abortion continue to heat up in the US, the Supreme Court faces increasing legal challenges and criticisms around access to medically induced abortions. The mifepristone debate is likely to have future implications for other drugs that require FDA approval, as well as the ability for healthcare providers to operate under reasonable scrutiny.
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