Can the FDA just ignore the Texas abortion pill ruling? Some lawmakers think so
Democrats and even some Republicans have proposed a novel approach to a Texas judge’s ruling against the abortion pill: Just ignore it.
Behind the idea is a concept known as “enforcement discretion,” which the Food and Drug Administration (FDA) regularly uses in order to make products more accessible.
Lawmakers including Sen. Ron Wyden (D-Ore.), Reps. Alexandria Ocasio-Cortez (D-N.Y.) and Nancy Mace (R-S.C.) have called for the FDA to ignore the opinion from U.S. District Judge Matthew Kacsmaryk suspending the FDA’s approval of mifepristone.
Federal officials have so far been cool to the suggestion; an official at Department of Health and Human Services (HHS) said Monday it would set a “dangerous precedent.”
However, HHS Secretary Xavier Becerra has said all options remain on the table as the Biden administration seeks to protect access to standard abortion care.
Here’s what you need to know about the debate into whether a federal agency can ignore a judicial order.
Secretary of Health and Human Services Xavier Becerra speaks during a Senate Finance Committee hearing to discuss the president’s fiscal 2024 budget for the Department on March 22. (Annabelle Gordon)
How the FDA ‘ignores’ regulations
In some specific cases, the FDA practices enforcement discretion, in which the agency chooses to not impose regulations and requirements on products and manufacturers, oftentimes to ensure an adequate supply will be available.
Enforcement discretion is not simply the FDA turning a blind eye to rules or requirements. Regulators issue public guidance on their intent to not enforce specific regulations and these decisions are usually temporary.
For example, the federal government put enforcement discretion into use at the start of the COVID-19 pandemic when hand sanitizer became scarce. Temporary guidelines were released in March 2020 allowing manufacturers that are not normally drug makers to create hand sanitizer. These guidelines were withdrawn by the end of 2021.
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David Cohen, law professor at the Drexel University Thomas R. Kline School of Law, compared enforcement discretion to a police officer who chooses not to penalize jaywalkers despite the fact they are breaking a law.
“Just like any other law enforcement agency, they determine they can’t enforce everything. They don’t have the human beings. They don’t have the ability to do that. So they have to pick and choose, and the FDA picks and chooses based on the safety of the drug,” Cohen told The Hill.
What lawmakers are arguing
Rep. Alexandria Ocasio-Cortez (D-N.Y.) reacts during a meeting at the Chhaya Community Development Corporation on July 6, 2022, in the Jackson Heights neighborhood of the Queens borough of New York. (AP Photo/Mary Altaffer)
As early as February, when the case in Texas was still being argued, Wyden urged the Biden administration and the FDA to ignore Kacsmaryk’s ruling if he decided in favor of blocking mifepristone’s authorization.
“There are moments in history where Americans and their leaders must look at circumstances like this one and say, ‘Enough.’ Not ‘let’s see how the appeals process plays out,’ or ‘let’s hope Congress can fix this down the road.’ Just, ‘Enough,’” the senator said in a floor speech.
Ocasio-Cortez argued there was “an extraordinary amount of precedent” for the White House to ignore the ruling, saying it was not unheard of to practice “consistency in governance until there is a higher court ruling.”
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Mace spoke out against “extreme views” on abortion, saying the vast majority of Americans are “somewhere in the middle” when it comes to the abortion debate.
“I think that that 90 percent would be OK with listening to the FDA rather than a judge who used an old law that was determined unconstitutional by the Supreme Court,” she said.
Historical precedent
Senate Finance Committee Chairman Ron Wyden (D-Ore.) speaks during a hearing to discuss the president’s fiscal 2024 budget for the Department of Health and Human Services on March 22.
Wyden pointed back to when former President Lincoln decided to ignore the Supreme Court’s ruling in Dred Scott v. Sandford, which found that men of African descent could never be American citizens.
Lincoln pushed back against this decision as “erroneous,” arguing how it was not unanimous and had not been reaffirmed by other cases.
Lawmakers like Mace have also zeroed in on Kacsmaryk’s references to the Comstock Act in his opinion. The 1873 law banned mailing contraceptives, but legal experts have pointed out that it hasn’t been enforced in decades.
And the Supreme Court previously ruled in favor of federal agencies deciding to not pursue regulatory enforcement.
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In the 1984 case of Heckler v. Chaney, death row inmates argued that the drug used for executions was not approved for use in executing human beings and the FDA should enforce the regulations preventing it from being used.
The FDA declined to enforce the laws that the plaintiffs alleged was being violated and a district court initially ruled that the department’s decision to not enforce was not judicially reviewable.
This ruling was appealed, but the Supreme Court ultimately affirmed the FDA’s decision to not pursue enforcement was not judicially reviewable under the Administrative Procedure Act.
The abortion pill won’t be going away
In the case of mifepristone, Kacsmaryk has ruled to block its authorization for use in inducing abortions. However, it remains unclear if this extends to the manufacturing and sale of the drug. His ruling is set to go into effect at the end of this week.
Mifepristone still has approval as a drug separate from the authorization for use in chemical abortions. The FDA in 2012 approved mifepristone under the name Korlym as a drug to treat hyperglycemia in patients with Cushing syndrome.
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If authorization of mifepristone is ultimately blocked, the FDA could theoretically adhere to Kacsmaryk’s order while also choosing to not enforce penalties on providers who prescribe and distribute it for abortions — which experts noted has been done before (such as in the Heckler v. Chaney case).
Tacitly allowing mifepristone to remain on the market would be supported by the more than 20 years since it has been approved, in which evidence overwhelmingly showed it to be a safe and effective medicine.
Experts are skeptical
But even if the FDA decided to cite historical precedent in ignoring the ruling, public health experts are wary of this option due to the uncertainty it could create.
Georges C. Benjamin, executive director of the American Public Health Association, told The Hill that enforcement discretion wouldn’t protect health care providers from consequences outside of the FDA.
“Does not mean that you still can’t be sued by somebody. Does not mean that if you’re a licensed professional that your licensing board couldn’t come after you based on a complaint,” Benjamin said.
“If you’re in a state that has put restrictions on abortion then there are a bunch of state agencies that can come after you, including probably the attorney general.”
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