A US appeals court on Wednesday ruled access to the abortion pill should be preserved with some limits, rejecting part of an order from a judge in Texas that would have effectively banned the sale of the drug across the country.
The decision, however, won’t have an immediate impact on access to the medication, mifepristone. The pill remains available under an April order from the US Supreme Court that will stay in effect until the high court rules again on the matter or refuses to hear the case on appeal.
In its 2-1 ruling, the majority affirmed some limits, saying decisions made by the US Food and Drug Administration to expand access to the pill after 2016 should be rolled back, upholding part of the Texas order.
“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” Judge Jennifer Elrod wrote for the majority.
The decision follows a contentious hearing in May when the Republican-appointed judges on the US 5th Circuit Court of Appeals in New Orleans appeared skeptical of the government’s assertions that mifepristone is safe and that it was lawfully approved.
During the hearing, the justices expressed skepticism that the FDA appropriately considered the safety risks of mifepristone before the agency approved it for use in 2000 and again when it took steps to loosen restrictions on the drug in later years.
FDA Decisions
The judges also bristled at assertions from government lawyers that courts should not second guess FDA decisions regarding the safety of a drug.
In his April ruling, US District Judge Matthew Kacsmaryk in Amarillo, Texas, blocked the decades-old federal approval of mifepristone — in what appeared to be the first time a federal judge has challenged the agency’s determination that a drug is safe for use.
Kacsmaryk sided with the group of anti-abortion doctors behind the lawsuit and said the agency fast-tracked approval of the drug without sufficient scientific evidence because it was facing significant political pressure to expand abortion access.
Circuit Judge James C. Ho, in his dissent, said he would had affirmed Kacsmaryk’s order blocking the sale of the abortion drug, saying the FDA hadn’t properly vetted the pill.
The legal battle over mifepristone has thus far has been limited to Kacsmaryk’s temporary order, not on the merits of the lawsuit itself. Once the question of the order is resolved, litigation will continue in district court in Texas and Kacsmaryk will rule on whether federal approval of mifepristone should be permanently revoked. The outcome of the high-profile case has the potential to upend access to medication abortion across the country, even in states where it remains legal.
Medication abortion has become the most popular method for terminating a pregnancy in the US and has emerged as a key target for anti-abortion advocates in the wake of Roe v. Wade being overturned in June. Mifepristone is used as part of a two-pill regimen to terminate pregnancies and treat miscarriages. It is followed by misoprostol, which can also be used on its own to terminate a pregnancy.
Alliance Defending Freedom, the Christian legal advocacy group, challenged FDA approval of mifepristone in a November lawsuit. The case has drawn backlash from drug manufacturers and pharmaceutical executives, who say that it could undermine the FDA’s authority to regulate drugs.
The appellate case is Alliance for Hippocratic Medicine v. US Food and Drug Administration, 23-10362, 5th US Circuit Court of Appeals.
