Jamie & Tami Rowen: Louisiana reclassification restricts abortion pill access

The Louisiana Legislature approved a bill May 23 reclassifying the abortion drugs mifepristone and misoprostol as “controlled, dangerous substances.”

Both have a long history of safe and effective use in medication abortions, in addition to treatment for miscarriages and other conditions. But the measure makes it illegal to possess them without a prescription, and covers people involved in their transportation or storage.

As a legal scholar (Jamie) and obstetrician/gynecologist (twin sister Tami), we are prepared to explain the implications for both patients and providers.

In the U.S., prescription medications are divided into two categories, not controlled and controlled. Historically, this has been based largely on likelihood for mental and physical addiction.

Mifepristone and misoprostol have long been classified, across the country, as not controlled substances. Though a prescription is required to obtain them, criminal consequences have never been imposed for possessing them.

It was already against the law in Louisiana to provide a medical or surgical abortion absent the threat of a woman’s death or “substantial and irreversible bodily impairment.” That requires residents seeking medication abortion to order the requisite drugs from out-of-state suppliers.

The new law, however, reclassifies the drugs, making their transport or storage illegal for anyone without a prescription. That subjects anyone involved on the Louisiana end of the supply chain to a potential penalty of one to five years in prison and up to $5,000 in fines.

Controlled substances are categorized by schedule. Under federal law, schedule designations are determined by factors such as potential for abuse and risk to public health.

Louisiana has established five schedules, mirroring the federal system. It has moved the abortion drugs to Schedule 4.

That is reserved for drugs with a currently accepted medical use and little potential for abuse, but which may lead to a degree of physical or psychological dependence. By classifying mifepristone and misoprostol under Schedule 4, then, the Legislature is asserting, without evidence, that they carry a risk for dependence or abuse.

Louisiana doctors say the bill could make it harder for them to obtain the drugs for legitimate maternal care in a state that already has some of the highest maternal mortality rates in the U.S.

What science, if any, did the Legislature rely on? The classification has no science behind it, as no studies suggest the drugs pose risk of dependence or abuse.

Mifepristone can be used for elective abortion, miscarriage management and even for labor induction, being more effective than traditional treatments with misoprostol alone.

In terms of safety, it is useful to compare the risks of mifepristone with another commonly used drug, Viagra. Though requiring a prescription, Viagra is not classified as a controlled substance.

For mifepristone, there are reported cases, though rare, of nonspecific fatal sepsis that could be related to women undergoing medical abortion in the U.S. Viagra was linked to 1,473 major adverse outcomes and 522 reported deaths in the U.S. during a single 13-month study period.

Misoprostol was approved by the Food and Drug Administration for its ability to lessen the symptoms of gastric ulcers, but is widely used throughout obstetrics and gynecology for inducing labor and stopping postpartum hemorrhage. Side effects for those using misoprostol for ulcers or gynecological care are rare, particularly compared with traditional Schedule 4 drugs.

The law’s criminal penalties could be imposed regardless of whether the pills were designated for a person electing abortion or something else entirely, such as trying to treat a miscarriage or gastric ulcer.

By punishing people engaged in transportation or storage, the law may create new barriers to access for a variety of people, even if it doesn’t criminalize pregnant people who consume the pills.

The Supreme Court has interpreted the Constitution as allowing both the federal government and the states to regulate controlled substances. This means there can be variations in access to medications state to state.

However, states typically follow federal scheduling guidelines and practices when making their own drug classifications. A well-known but rare exception to this common practice is cannabis, which many states have decriminalized or legalized contrary to federal law.

The immediate impacts will be on clinical studies on the two drugs in other states that have patients in Louisiana.

Clinical trials with medications that are not controlled substances may be conducted in any state with little or no added state regulation. Clinical trials of controlled substances have additional regulatory requirements that can add costs and delay development.

The most likely long-term outcome is that other states may make similar legislative attempts to curb access to medication abortion, particularly states that have unsuccessfully tried to stop access to medical abortion in other ways.

From The Conversation, an online repository of lay versions of academic research findings found at theconversation.com/us. Used with permission.


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