Pallone Releases New Report on the Dangerous Effects of Louisiana’s Restrictions on Misoprostol and Mifepristone

Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ) released a report today on Louisiana’s new law that classifies misoprostol and mifepristone as controlled substances and the threat that it poses to timely, comprehensive health care. The Committee Democratic staff report details how the new classification will make it harder for doctors to treat patients in emergency situations, further restrict reproductive rights, endanger women’s lives, and serve as a blueprint for Republican policymakers in other states.

“Requiring lifesaving medications to be kept in a lockbox and threatening doctors with jailtime and fines will only make Louisiana’s existing maternal health crisis worse,” Pallone said. “This report demonstrates that Louisiana’s new law is clearly intended to create a chilling effect on both patients and doctors that will undoubtedly put women’s lives at risk.

“Louisiana already has one of the worst maternal mortality rates in the nation—nearly double the national average—and this law will make it worse,” Pallone continued. “I also fear it will exacerbate the glaring racial health disparities in the state, where Black women account for 62 percent of pregnancy-related deaths and are four times more likely to die of pregnancy-related causes than white women.  

“Unfortunately, this law is an example of what’s to come if Trump is empowered to pursue the extreme Project 2025 agenda, which calls for surveillance of these medications. This would allow Republicans to create a dangerous environment for investigating women, their loved ones, and doctors in their crusade to totally eliminate all access to abortion,” Pallone concluded. “We must put a stop to this madness. Democrats are fighting for the fundamental right of a woman to make decisions about her own body. We can enshrine that right by passing the Women’s Health Protection Act to restore Roe’s protections nationwide and end these draconian reproductive restrictions imposed by Republicans across the country.”

Background on the Louisiana Law:

On October 1, Louisiana’s new law—Act 246—went into effect classifying misoprostol and mifepristone as controlled substances, which imposes onerous and unnecessary restrictions on access to the Food and Drug Administration (FDA)-approved medications. Neither drug has shown potential for abuse, dependence, or public health risk.

Under the law, misoprostol and mifepristone are classified as Schedule IV drugs and without a valid prescription or order from a practitioner possession of either is generally prohibited. Penalties range from one to five years in prison and a fine of up to $5,000. Penalties for manufacturing or distributing a Schedule IV substance in violation of the law can result in up to 10 years in prison and a fine of up to $15,000.

Report Finds No Legitimate Medical Reason to Schedule Misoprostol and Mifepristone as Controlled Substances:

Both federal and Louisiana state law have similar criteria for determining whether and how a drug should be scheduled as a controlled substance without new legislation. In order for a substance to be scheduled, strict criteria must be met establishing that the drug has potential for abuse, which must be corroborated by medical and scientific evaluation.

In the case of both misoprostol and mifepristone no such evaluation took place. Instead, the Louisiana legislature politicized its scheduling of drugs—an otherwise legitimate medical tool for preventing drug abuse—and directly placed mifepristone and misoprostol under the state’s controlled substances Schedule IV, ignoring all existing scientific and medical data about these safe and effective FDA-approved drugs. There is nothing in the pharmacological makeup of these drugs that leads to dependency, increased risk of misuse, or death in the case of overdose, nor is there any scientific or medical basis for including mifepristone or misoprostol under any controlled substances list.

Report Finds Making Misoprostol a Controlled Substance Will Lead to Worse Health Outcomes in Louisiana:

By categorizing misoprostol and mifepristone as controlled substances, the Louisiana legislature intentionally restricted access to life-saving medications, instilled unnecessary fear in providers and patients, and furthered a false narrative about the safety of these essential medications. 

The World Health Organization lists misoprostol as an essential medicine for pregnancy, childbirth, and postpartum care due to its safety profile, high efficacy for treating and preventing hemorrhage, and accessibility for emergency care. It is also regularly used to treat other conditions, including induction of labor for childbirth and to reduce the risk of a patient developing gastric ulcers, and is preferred over other similar drugs because it has fewer side effects and is safe for people with other health complications. 

In an outpatient setting, miscarriage care could now be delayed due to lack of immediate access to misoprostol, causing women to lose more blood, deteriorate quicker, heal at slower rates, and have a heightened risk of requiring surgery.  

For those receiving care in a hospital setting, women experiencing postpartum hemorrhaging—which often occurs quickly and unexpectedly—may face excessive and otherwise preventable blood loss, causing further complications, and increasing the possibility for surgery. Additionally, alternative medications to misoprostol may be harmful for some patients with common health problems like high blood pressure or asthma.

The law is also expected to add further stress to Louisiana’s strained health care system, which is already experiencing primary care provider shortages and maternal care deserts—especially in rural parts of the state. A report released by the Committee in August detailed the devastating effects of the Dobbs decision on medical education.

Restoring Reproductive Health Care Rights:

In order to undo the harm done by Louisiana’s law as well the other harmful effects of the Dobbs decision, the report calls for restoring nationwide access to comprehensive reproductive health care. H.R. 12, the Women’s Health Protection Act, would re-establish the right to abortion and restore health care providers’ ability to provide this care, free from state laws that restrict them for medically unnecessary reasons. 

Read the full report, HERE.

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