WHAT Is The HHS and Biden Considering Doing?

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Health and Human Services (HHS) Secretary Xavier Becerra said Sunday that the Biden administration is considering defying a conservative federal judge’s order that suspends the approval of mifepristone, the nation’s most widely used abortion drug.

“We want the courts to overturn this reckless decision,” Becerra said on CNN’s “State of the Union” of the ruling issued Friday by U.S. District Court Judge Matthew Kacsmaryk. “We want, yes, that women continue to have access to a drug that’s proven itself safe. Millions of women have used this drug around the world.”

Kacsmaryk, who was appointed to the Northern District of Texas by President Donald Trump in 2019, ordered the U.S. Food and Drug Administration (FDA) to put a hold on its approval of mifepristone while a civil lawsuit over the medication’s safety proceeds.

Mifepristone received FDA approval in 2000 alongside another drug called misoprostol.

In a typical chemical abortion, the pregnant woman first takes mifepristone to block the hormone progesterone and thereby deprive the unborn child of nutrients needed to stay alive, and then takes misoprostol to induce labor to expel the dead child.

The lawsuit, filed by conservative advocacy group Alliance for Hippocratic Medicine, accused the FDA of failing to study the safety of those drugs under the labeled conditions of use, disregarding the potential negative effects the hormone-blocking regimen has on pregnant girls, and removing the few safeguards that were in place. Kacsmaryk found those arguments plausible.

“The Court does not second-guess FDA’s decision-making lightly,” he wrote in the decision (pdf). “But here, FDA acquiesced on its legitimate safety concerns—in violation of its statutory duty—based on plainly unsound reasoning and studies that did not support its conclusions.”

Kacsmaryk’s order gave the federal government seven days to appeal. Becerra pledged that, in the mean time, his department will “do everything” to make sure women have access to mifepristone.

“We intend to do everything to make sure it’s available to them not just in a week, but moving forward, period, because mifepristone is one of the safest and most effective medicines that we have seen over the last 20 years to help women with their health care, especially abortion care,” he said.

When asked whether the Biden administration would recommend that the FDA ignore the court order, Becerra replied that, “Everything is on the table.

“The president said that way back when the Dobbs decision came out,” he said, referring to last summer’s U.S. Supreme Court decision that ended nearly 50 years of federal protection of abortion and sent the abortion question back to individual states to decide. “Every option is on the table.”

Becerra further argued that Kacsmaryk’s order could undermine the legality of any FDA-approved drug on the market because it seeks to invalidate the agency’s approval process.

“First and foremost, when you turn upside down the entire FDA approval process, you’re not talking about just mifepristone, you’re talking about every kind of drug,” Becerra told CNN’s Dana Bash. “You’re talking about our vaccines, you’re talking about insulin, you’re talking about the new Alzheimer’s drugs that may come on.”

HHS later on Sunday tried to walk back on Becerra’s suggestion that the FDA should ignore the ruling.

“People are rightly frustrated about this decision — but as dangerous a precedent it sets for a court to disregard FDA’s expert judgment regarding a drug’s safety and efficacy, it would also set a dangerous precedent for the Administration to disregard a binding decision,” Kamara Jone, HHS spokesperson, wrote in a tweet.

The Biden administration has already filed an appeal, which came out the same day an Obama-appointed federal judge in Washington state ruled that the FDA has placed “burdensome” and “unnecessary” dispensing restrictions on mifepristone.

In his ruling, U.S. District Court Judge Thomas Rice sided with a group of 17 Democratic state attorneys general who challenged the FDA’s dispensing restrictions in an effort to expand access to the pill. Rice partially granted their request by blocking the FDA from making any changes to the drug’s access in the 17 states that sued, saying that a nationwide injunction is “inappropriate where there is the potential for competing litigation.”

The existences of two dueling federal court orders is expected to increase the odds that the Supreme Court may intervene.