On April 21, The Supreme Court issued a stay (or pause) on a Texas judge’s decision to revoke FDA approval of mifepristone, effectively removing it from the market. Since the passage of the Pure Food and Drug Act of 1906, the FDA has made decisions on the safety and efficacy of the product.

Immediately following the Texas ruling, in an unprecedented situation, a federal court in Washington state issued a conflicting decision, ordering the FDA to keep mifepristone available under the FDA’s existing regulations. Oral arguments in this case before the 5th Circuit Court of Appeals will be on May 17. ASRM and other leading medical organizations have joined amicus briefs urging continued access to abortion pills and continue to monitor this and related litigation actively.

On Friday, April 7, a single, federal judge in Texas issued a ruling that stays, for one week, FDA approval of mifepristone, effectively removing it from the market. Since the passage of the Pure Food and Drug Act of 1906, the FDA has been charged with making decisions on the safety and efficacy of the product. The Biden administration filed an appeal on Monday, April 10.

A ban has been enacted on in-state abortion care. The import of these bans for the practice of reproductive medicine and, specifically, the use of Assisted Reproductive Technology (ART) to build families, varies on a state-by-state level. While the majority of states’ abortion ban statutes are applicable in the context of a pregnancy, many state laws also include definitions stating that “personhood” begins at fertilization or even conception. Such definitions -- whether intentionally or not -- have the potential to implicate and even ban the use of ART, including in vitro fertilization (IVF), though some states have taken steps to carve this out as allowable. In a growing number of states, statutory restrictions severely limit access to abortion care and implicitly threaten the unhindered practice of reproductive medicine.
 

At time of this publication, a decision looms on a federal lawsuit (Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, 2:22-cv-00223, US District Court, Northern District of Texas (Amarillo).) seeking to revoke the FDA’s approval of mifepristone, a proven, safe abortion medication. In a single ruling (pending its expected review), a non-elected, Trump-appointed judge who many view as hand-selected for this role through venue shopping, has the potential to halt otherwise legal abortions across the country, even in states that have acted to protect abortion rights and prioritize patient and physician autonomy. The Biden administration plans to appeal the decision if he rules to ban the medication, leaving the short- and long-term landscape murky for patients and providers alike. On March 15, at a hearing on the case, the judge reportedly seemed open to arguments by abortion advocates that mifepristone was not properly vetted by the FDA. The agency has strongly contested this assertion and Vice President Kamala Harris cautioned, in remarks on the same day, the implications a ruling based on such an argument could have serious implications for the approval and availability of a wide range of medications (https://www.nytimes.com/2023/03/16/us/politics/iowa-kamala-harris-abortion.html).

Abortion Prohibition

• The Texas Governor signed into law the Human Life Protection Act in 2021. This law was drafted to go into effect 30 days after official publication of a Supreme Court opinion overturning Roe v. Wade, so it became effective on August 25, 2022. Tex. Health & Safety Code, §§ 170A.001 to 170A.007.
  • The law prohibits performing, inducing, or attempting to perform an abortion unless a physician has determined that the pregnancy is life-threatening or poses a serious risk of substantial impairment of a major bodily function unless an abortion is performed or induced.

Civil Suits for Performing, Inducing or Aiding & Abetting Abortion

• The Texas Heartbeat Act (S.B. 8) went into effect in 2021 allowing private citizens to sue anyone who performs or induces an abortion, or knowingly engages in conduct that aids or abets the performance or inducement of an abortion after a “fetal heartbeat” has been detected, except in the case of a documented medical emergency.
  • The scope of conduct that “aids or abets” an abortion is unclear, except that the law specifically references paying for or reimbursing the costs of an abortion through insurance or otherwise.
  • If a citizen is successful in an action the court is instructed to award damages of not less than $10,000 for each abortion, plus costs and attorney’s fees.
  • The Human Life Protection Act states that it does not abolish or impair any other remedy available in a civil suit, so presumably a private citizen could continue to pursue civil actions under Texas Heartbeat Act for aiding and abetting abortion.

Pre-Roe Abortion Prohibition

• Statutes that were in effect from 1925 (and earlier) until they were “impliedly repealed” by Roe v. Wade prohibited any person administering a drug or any means to procure an abortion. Following the Dobbs decision, the Texas Supreme Court ruled that this pre-Roe law was still enforceable. Considering the more recently passed laws described above, it’s not clear 25 whether or how prosecution and enforcement of this law might be reconciled with those. Texas Rev. Civil Stat. Tit. 4512.1-.6

• It does not appear that current abortion restrictions in Texas will apply to IVF or other reproductive medicine services outside the context of a pregnancy.
• There are no explicit references to IVF or reproductive medicine services in current abortion laws.
• The potential civil penalties in the Texas Heartbeat Act for aiding and abetting an abortion apply only to abortions performed after detection of fetal cardiac activity within the gestational sac, so it would not be applicable to any services or procedures related to an embryo pre-implantation. 

In The Human Life Protection Act includes the following definitions:

• “Abortion” means using or prescribing any instrument, drug or other means with the intent to cause the death of an unborn child of a woman known to be pregnant.
• “Fertilization” means the point in time when a male human sperm penetrates the zona pellucida of a female human ovum.
• “Unborn child” means in individual living member of the homo sapiens species from fertilization until birth, including the entire embryonic and fetal stages of development.

The Texas Heartbeat Act includes the following definitions:

• “Fetal heartbeat” means cardiac activity or the steady and repetitive rhythmic contraction of the fetal heart within the gestational sac.
• “Unborn child” means a human fetus or embryo in any state of gestation from fertilization until birth.

Note, however, in both statutes the term “unborn child” is used only in the context of a pregnancy.

• The Human Life Protection Act includes both criminal and civil penalties, as well as disciplinary action against the licensure or permit of a physician or other health care practitioner who performs, induces, or attempts an abortion in violation of the law. Texas Health & Safety Code §§ 170A.004, 170A.005, 170A.007.
• The Texas Heartbeat Act provide for civil action by private citizens against individuals who perform or induce an abortion, or aid and abet the performance or inducement of an abortion, in violation of the law. Texas Health & Safety Code § 171.208.
   

House Bill 1280- “Human Life Protection Act of 2021”

Texas Statutes & Court Rules | Chapter 170A. Performance of Abortion

Health & Safety Code

The statute does not appear to be applicable to IVF and reproductive medicine services prior to implantation of embryos.

There are no explicit references to IVF or reproductive medicine services.

• “Abortion” is specifically defined as an act intending cause the death of an unborn child of a woman known to be pregnant.”
• As pregnancy requires “a living unborn child within [the pregnant woman’s] body” a fertilized embryo that is not within a pregnant woman’s body would likely not be within the scope of this law.
• he statute does define an unborn child as existing from fertilization until birth, but the prohibition is limited to abortion of an unborn child of a woman known to be pregnant.

Are there any penalties in this law that could apply to ART procedures?

Relevant definitions

• “Abortion” means the act of using or prescribing an instrument, a drug, a medicine, or any other substance, device, or means with the intent to cause the death of an unborn child of a woman known to be pregnant. The term does not include birth control devices or oral contraceptives. An act is not an abortion if it is done with the intent to:
  • Save the life or preserve the health of an unborn child;
  • Remove a dead, unborn child whose death was caused by spontaneous abortion; or
  • Remove an ectopic pregnancy.
• "Fertilization” means the point in time when a male human sperm penetrates the zona pellucida of a female human ovum.
• “Pregnant” means the female human reproductive condition of having a living or unborn child within the female’s body during the entire embryonic and fetal stages of the unborn child’s development from fertilization until birth.
• "Unborn child” means an individual living member of the homo sapiens species from fertilization until birth, including the entire embryonic and fetal stages of development.

Do the definitions/terms of the trigger law apply to other areas of state code?

What is the “trigger” for this law to take effect?