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Louisiana Becomes First State to Classify Mifepristone and Misoprostol as Controlled Substances
Thursday, May 30, 2024

On May 25, 2024, Louisiana Governor Jeff Landry signed a bill, SB 276, into law that will classify medications commonly used in pregnancy and to treat stomach ulcers (mifepristone and misoprostol) as controlled substances.

The provision classifying mifepristone and misoprostol as controlled substances was added in an amendment to SB 276 to make “coerced” abortions unlawful in the state. The new law is scheduled to take effect on October 1, 2024.

SB 276 represents the first attempt by a state to categorically restrict certain types of medication because they can be used for abortion. Many states have laws restricting the prescription and dispensing of drugs determined to be “abortion-inducing drugs,” but such drugs are only restricted if they are intended to be used to produce an abortion.[1] The laws restricting “abortion-inducing drugs” left open the ability of medical professionals to prescribe these drugs without restriction for non-abortion purposes, such as managing the effects of miscarriage or, in the case of misoprostol, preventing stomach ulcers. Now, due to these drugs’ association with abortion, they will be subject to new restrictions in the state and may impact the treatment of conditions unrelated to abortion.

Background

SB 276 was introduced by Louisiana State Senator Thomas Pressly, whose sister was the victim of her husband’s attempt to end her pregnancy by dosing her with a substance containing misoprostol without her knowledge or consent. This incident occurred in Texas, where abortion,[2] aiding and abetting abortion,[3] and possessing medication with the intent to use it for an unlawful abortion[4] are all strictly prohibited under Texas law. While Texas law would have allowed the man to be charged under Texas’s felony abortion prohibition, which could have resulted in imprisonment of up to 20 years,[5] the man was charged with felony assault to induce abortion and, as a result of a plea bargain, was sentenced to 180 days in jail with additional probation.

Like Texas, Louisiana already criminalizes anything determined to be an “abortion” [6] and separately criminalizes the use of “abortion-inducing drugs.” [7] Thus, the offense of a “coerced abortion” created by the new law may be a meaningless distinction given the existing status of criminalization of the procedure in Louisiana.

Louisiana SB 276: What Does It Say?

In addition to the restriction on “coerced abortion,” SB 276 adds “any material, compound, mixture, or preparation containing any detectable quantity of mifepristone or misoprostol” to the state’s list of Schedule IV controlled substances.[8] The new law also criminalizes possession of the drug for anyone except for a currently pregnant person who uses the drug for their own consumption. Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, more commonly known as the federal Controlled Substances Act, sets the floor for restrictions on medications deemed to be addictive or deemed to have the potential for abuse, and states are allowed to set more stringent restrictions on the drugs, so long as they meet the federal floor.

However, it is unusual for drugs without any known pattern of abuse to be designated as controlled substances. For example, if a drug were added to the state’s list of controlled substances through rulemaking, the drug would have to be evaluated for factors such as its “actual or relative potential for abuse,” “history and current pattern of abuse,” “scope, duration and significance of abuse,” and “[w]hat, if any, risk there is to public health.”[9] Mifepristone, which is currently the subject of litigation before the U.S. Supreme Court,[10] is considered by the U.S. Food and Drug Administration (FDA) to be safe and effective, based on a “thorough and comprehensive review of the scientific evidence.”[11] Misoprostol, a drug used to treat and reduce the risk of stomach ulcers, has been approved by the FDA since the late 1980s.[12] Now, in Louisiana, mifepristone and misoprostol will join other Schedule IV drugs, such as the opioid narcotic Tramadol and the depressants Diazepam (Valium) and Lorazepam (Ativan).[13] Unlawful possession could result in a criminal penalty punishable by up to 10 years’ imprisonment.[14]

Effect of the Law

Though the new law is positioned as “protecting” women,[15] the amendment adding mifepristone and misoprostol to the list of substances categorized under the state’s controlled substances may produce consequences that could lead to worsened access to care in a state already plagued by poor maternal mortality outcomes and other issues relating to pregnancy care.

recent study by the group Physicians for Human Rights found that since Louisiana’s total prohibition on abortion took effect, pregnant people experiencing miscarriage in the state have been forced to undergo medically unnecessary cesarean section surgeries to avoid infection instead of receiving medications like mifepristone or misoprostol in an attempt to remain compliant with the state’s abortion prohibitions. The report also documents delays both in prenatal care appointments and to severely ill pregnant patients, such as women with cancer, patients with heart problems, kidney failure, and hospitalized patients. Moreover, the report compiled incidents of delays resulting in patient harm, such as one patient who was forced to endure the rupture of her fallopian tubes before receiving medical care.

Now, with mifepristone and misoprostol set to be restricted as controlled substances this fall, providers who wish to prescribe the drug must ensure they have additional licensure with the state,[16] facilities must adhere to additional storage requirements, and all prescriptions must be tracked through a state database.[17] Notably, state law enforcement officials can access this database without a subpoena.[18] This may further chill providers trying to not only treat pregnancy complications but also prescribe these medications to patients with no connection to pregnancy, such as patients seeking treatment for stomach ulcers.

The Louisiana Chapter of the American Society of Addiction Medicine lobbied against SB 276 before it was enacted into law, stating that the bill “goes against the spirit of the drug scheduling system” and would “perpetuate [] barriers and dissuade pregnant people with [substance use disorder] from seeking treatment, leading to worsened outcomes for patients.” Dr. Jennifer Avegno of the New Orleans Health Department worried that classifying mifepristone and misoprostol as drugs of dependence would only worsen “fear and confusion about these medications.”

Louisiana’s approach may be an attempt to further scrutinize access to abortion in the state. Physicians in states with “shield laws” that protect providers from out-of-state subpoenas may still be prescribing these medications via telehealth into restrictive states despite harsh penalties within restrictive states.[19] While a battle between states seeking to restrict access to abortion and states with shield laws may be coming, for the time being, providers in states with shield laws must only operate in a manner that complies with their states’ laws to avail themselves of the protection and would not need to abide by the additional restrictions Louisiana poses on mifepristone and misoprostol to prescribe these medicines from their state. Nevertheless, the new law could also be copied by other states seeking to further restrict access to medication abortion and to target possession of the drug in particular. EBG will continue to monitor changes in the post-Dobbs landscape.
 

ENDNOTES

[1] See, e.g., La. Stat. Ann. § 14:87.1(2)(a) (“‘Abortion-inducing drug’ means any drug or chemical, or any combination of drugs or chemicals, or any other substance when used with the intent to cause an abortion, including but not limited to RU-486, the Mifeprex regimen, misoprostol (Cytotec), or methotrexate.”); see also Tx Health & S. § 171.061(2) (“‘Abortion-inducing drug’ means a drug, a medicine, or any other substance, including a regimen of two or more drugs, medicines, or substances, prescribed, dispensed, or administered with the intent of terminating a clinically diagnosable pregnancy of a woman and with knowledge that the termination will, with reasonable likelihood, cause the death of the woman's unborn child. The term includes off-label use of drugs, medicines, or other substances known to have abortion-inducing properties that are prescribed, dispensed, or administered with the intent of causing an abortion, including the Mifeprex regimen, misoprostol (Cytotec), and methotrexate. The term does not include a drug, medicine, or other substance that may be known to cause an abortion but is prescribed, dispensed, or administered for other medical reasons.”) (emphasis added).

[2] Tx Health & S. §§ 170A.002, .004, .005. Performing, inducing, or attempting an abortion in Texas are felonies punishable by up to life in prison, with civil penalties of $100,000 per offense.

[3] Tx Health & S. § 171.208 (Texas’s so-called “bounty” law for aiding and abetting abortion).

[4] Tx Health & S. § 171.063(a) (“A person may not knowingly provide an abortion-inducing drug to a pregnant woman for the purpose of inducing an abortion in the pregnant woman or enabling another person to induce an abortion in the pregnant woman unless: (1) the person who provides the abortion-inducing drug is a physician; and

(2) the provision of the abortion-inducing drug satisfies the protocol authorized by this subchapter.”)

[5] Tx. Penal Code § 12.33(a) (“An individual adjudged guilty of a felony of the second degree shall be punished by imprisonment in the Texas Department of Criminal Justice for any term of not more than 20 years or less than 2 years.”). 

[6] See La. Stat. Ann. § 14:87.7. Louisiana exempts medical procedures performed by a physician (i) intended to save the life or preserve the life of an unborn child, (ii) to remove a fetus that has been declared “dead,” (iii) to remove an ectopic pregnancy, (iv) to remove a “medically futile” fetus, or (v) to prevent the death or “serious, permanent impairment of a pregnant person” from the definition of an “abortion.” La. Stat. Ann. § 14:87.1 (1)(b).

[7] La. Stat. Ann. § 14:87.9 (“Criminal abortion by means of an abortion-inducing drug is committed when a person knowingly causes an abortion to occur by means of delivering, dispensing, distributing, or providing a pregnant woman with an abortion-inducing drug.”).

[8] LA SB 276 (2024).

[9] La. Stat. Ann. § 40:962(C).

[10] See FDA v. Alliance for Hippocratic Medicine, et al., No. 23-235 (argued Mar. 26, 2024).

[11] FDA, Questions and Answers on Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation.

[12] FDA-Approved Drugs, Cytotec (Misoprostol).

[13] La. Stat. Ann. § 40:964.

[14] LA SB 276 (2024).

[15] Louisiana’s Governor, Jeff Landry, released a statement on May 25, 2024, noting that “[t]his bill protects women across Louisiana and I was proud to sign this bill into law today.”

[16] La. Stat. Ann. § 40:973.

[17] See Louisiana Board of Pharmacy, Prescription Drug Monitoring Program.

[18] See La. Stat. Ann. § 40:988.

[19] See, e.g., Abortion Shield Laws: A New War Between the States., N.Y. Times, Feb. 22, 2024.

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