A court decision in Amarillo on February 10 could have sweeping effects nationwide on access to abortion pills.
The pro-life group Alliance Defending Freedom (ADF) has filed a lawsuit against the U.S. Food and Drug Administration (FDA) on behalf of the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, the Christian Medical & Dental Associations, and doctors Shaun Jester, Regina Frost-Clark, Tyler Johnson, and George Delgado.
The lawsuit alleges that in its approval of chemical abortion drugs, the FDA was wrong to describe pregnancy as an “illness” and deem the effect of abortion drugs a “meaningful therapeutic benefit.”
“Pregnancy is not an illness, and chemical abortion drugs don’t provide a therapeutic benefit — they end a baby’s life and they pose serious and life-threatening complications to the mother,” said ADF Senior Counsel Julie Marie Blake in a statement.
The ADF lawsuit also offers examples of the FDA’s approval process.
In 2016, the FDA extended the permissible gestational age of a baby for when women may be administered chemical abortion drugs from seven to 10 weeks.
The FDA also made changes to the dosage and route of administration by reducing the number of necessary in-person doctor visits from three to one, expanding who could prescribe abortion drugs, and eliminating requirements to report non-fatal complications.
In 2021, the ability to send chemical abortion drugs through telehealth and mail order was expanded by the FDA. Texas Senate Bill 4 bans access to abortion-inducing pills in the state.
Attorneys for the FDA and U.S. Department of Health and Human Services have said in a statement that to undo the distribution of abortion drugs would go against a “long standing scientific determination based on speculative allegations of harm.”
The abortion drug at the center of this case is mifepristone, a hormone-blocking drug that affects the hormone progesterone, which is vital for pregnancy.
Mifepristone is commonly taken with another drug named misoprostol, which together will end a pregnancy in the first 10 weeks.
After the Biden administration reversed a Trump-era requirement for in-person doctor visits to obtain mifepristone, the U.S. Supreme Court reinstated those measures in January 2021. That April, FDA Acting Commissioner Janet Woodcock said the FDA’s Center for Drug Evaluation and Research would “exercise enforcement discretion” for the requirement.
After the overturn of Roe v. Wade, the United States Postal Service (USPS) asked and was given guidance by the U.S. Department of Justice (DOJ) on how to approach the mailing of abortion pills.
This was in regards to the Comstock Act, which explains that “[e]very article or thing designed, adapted, or intended for producing abortion,” as well as “[e]very article, instrument, substance, drug, medicine, or thing which is advertised or described in a manner calculated to lead another to use or apply it for producing abortion,” is a “non mailable matter.”
In the DOJ opinion issued to the USPS, they noted that “consensus interpretation” has been that if items are not meant to be used unlawfully, then that does not prohibit a sender from sending them.
Further, the DOJ opinion explains how federal law does not prohibit the use of medication for abortion, and that since the drugs being sent can be used for other purposes than to induce abortions, USPS would not be able to assume that those drugs are non-mailable items.
The DOJ concluded that the Comstock Act does not prohibit the mailing of medication abortion drugs when the sender lacks the intent that the recipient will use them unlawfully, adding that “the fact that the drugs are being mailed to a jurisdiction that significantly restricts abortion is not a sufficient basis for concluding that mailing violates [the statue].”
The decision in Amarillo will be seen by Trump appointee federal Judge Matthew Kacsmaryk.
Kacsmaryk was formerly the deputy general counsel for First Liberty Institute, which has taken on high-profile cases including two that went before the Supreme Court. One of those was Kennedy v. Bremerton School District, where the court ruled a high school football coach had been discriminated against for his midfield prayers after games.
Known for not shying away from “culture war” issues, Kacsmaryk has been steadfast in his opinions on a variety of topics.
If Kacsmaryk rules in favor of the Alliance for Hippocratic Medicine, then mifepristone would temporarily be removed from telehealth services and in states where abortion is legal, physicians will only be able to prescribe in-person.
The case will move then to the Fifth Circuit and then potentially appealed up to the Supreme Court.
The Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration lawsuit could have a decision by February 10 when filing briefs are completed.
Tags:
Regional