Ruling Against Abortion Pill Mifepristone Could Affect Other FDA-Approved Drugs, HHS Secretary Warns

Topline

Health and Human Services Secretary Xavier Becerra said Sunday a Texas federal judge’s unusual decision to halt abortion pill mifepristone’s Food and Drug Administration approval could have an effect on other FDA-approved drugs or vaccines, promising “every option is on the table” to keep the drug available.

Mifepristone (Mifeprex), one of the two drugs used in a medication abortion, is displayed at the … [+] Women’s Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 15, 2022.

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Key Facts

Speaking on CNN’s State Of The Union, Becerra said the ruling by Judge Matthew Kacsmaryk—who took the highly unusual step of overriding a 23-year-old federal drug approval—“turn[ed] upside down the entire FDA approval process.”

The decision is not about “just mifepristone,” Becerra said: “You’re talking about every kind of drug. You’re talking about our vaccines. You’re talking about insulin. You’re talking about the new Alzheimer’s drugs that may come on.”

Crucial Quote

“If a judge decides to substitute his preference, his personal opinion for that of scientists and medical professionals, what drug isn’t subject to some kind of legal challenge?” Becerra said.

What To Watch For

The Biden Administration and the Department of Justice said Friday they will fight the mifepristone ban, and the DOJ filed an appeal that same day. Becerra told CNN “everything is on the table” to keep the drug available.

Surprising Fact

Some Democrats like Rep. Alexandria Ocasio-Cortez (N.Y.) have suggested the FDA ignore Kacsmaryk’s ruling and keep mifepristone available. When asked about that suggestion by CNN, Beccera did not directly answer the question, calling it “speculation.”

Key Background

On Friday, Kacsmaryk blocked federal approvals for mifepristone while litigation plays out. The ruling could have a significant effect on access to abortion, after many states have banned the procedure after the overturning of Roe v. Wade last year, leaving many patients to rely on telemedicine. Kacsmaryk, who was appointed by former President Donald Trump, issued a preliminary injunction on the medication that will take effect in one week so the government has time to appeal, rather than ordering the FDA to fully withdraw the drug’s approval On the same day, federal Judge Thomas Rice, who is based in Washington state, issued a decision ordering the FDA against “altering the status quo and rights as it relates to the availability of mifepristone,” though his ruling only applies to some states. The medication has been proven to be both safe and effective. It was approved by the FDA in 2000 and terminates pregnancies. It is commonly used in conjunction with misoprostol—which expels tissue and can be used for other medical purposes, including the treatment of miscarriages and postpartum hemorrhages.