Abortion Pill Access Preserved by Appeals Court, With Limits (3)

A US appeals court on Wednesday ruled that 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 2-1 decision is the latest in a complicated legal saga over mifepristone, which remains available for women seeking to end their pregnancies 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.

While the majority said it was too late to challenge the legality of the initial approval of mifepristone by the US Food and Drug Administration in 2000, it upheld some limits imposed by the Texas judge. The appeals court said FDA decisions after 2016 — allowing the drug to be taken later in pregnancy and mailed directly to patients — were likely unlawful and should be rolled back.

“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 Justice Department said it disagreed with the ruling and plans to file an appeal with the Supreme Court.

Read More: What’s Mifepristone? What’s the Fight Over It About?

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 2022. 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.

Skeptical Judges

Wednesday’s 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 judges 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.

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. The government argued it had more than two decades of evidence showing the pill was safe to use.

Dissent

Circuit Judge James C. Ho, in his dissent, said he would have affirmed Kacsmaryk’s order blocking the sale of the abortion drug, adding that the FDA hadn’t properly vetted the pill.

The legal battle over mifepristone thus far has been limited to Kacsmaryk’s temporary order, not on the merits of the lawsuit itself. The Biden administration plans to appeal the 5th Circuit’s decision on the Texas order to the Supreme Court, a DOJ spokesperson said.

Once there is a final ruling on the temporary order, litigation on the merits of the case 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.

“Today’s ruling does not affect the availability of mifepristone,” Alexis McGill Johnson, president and Chief Executive Officer of Planned Parenthood Federation of America, said in a statement. “But the 5th Circuit’s opinion makes it clear that mifepristone’s approval is very much still at risk, as is the FDA’s independence.”

Legal Fight

Alliance Defending Freedom, the Christian legal advocacy group, challenged the FDA’s approval of mifepristone in a November lawsuit. The case has drawn a backlash from drug manufacturers and pharmaceutical executives, who say that it could undermine the FDA’s authority to regulate drugs.

Erin Hawley, senior counsel and vice president of the Center for Life and regulatory practice at ADF, said Wednesday that her group is still deciding whether they plan to appeal the decision to the Supreme Court.

“Today the Fifth Circuit rightly required the FDA to do its job and to restore crucial safeguards for women and girls,” Hawley said during a call with reporters after the decision was released.

Wednesday’s decision by the 5th Circuit also preserved the FDA’s 2019 approval of GenBioPro Inc’s generic version of mifepristone. GenBioPro makes most of the mifepristone sold in the US.

“We remain concerned about extremists and special interests using the courts in an attempt to undermine science and access to evidence-based medication, as well as attempts to undermine the US Food and Drug Administration’s regulatory authority,” GenBioPro CEO Evan Masingill said in a statement.

The appellate case is Alliance for Hippocratic Medicine v. US Food and Drug Administration, 23-10362, 5th US Circuit Court of Appeals.

(Updates with DOJ saying it will appeal ruling.)

--With assistance from Celine Castronuovo.

To contact the reporter on this story:
Madlin Mekelburg in Austin at mmekelburg@bloomberg.net

To contact the editors responsible for this story:
Misyrlena Egkolfopoulou at megkolfopoul@bloomberg.net

Steve Stroth

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