Author: Sarah Aber

On January 3, 2023, the U.S. Food and Drug Administration (FDA) updated its risk evaluation and mitigation strategy (REMS) for reproductive health relating to “the abortion pill,” mifepristone. Mifepristone is a pill, used in combination with misoprostol, to terminate intrauterine pregnancies no later than 10 weeks past the individual’s last menstrual period. Additionally, it may be used for early-stage miscarriage management, and management of 2^nd and 3^rd trimester pregnancies where the fetus is no longer viable and has died before birth.

In 2011, the FDA implemented the Mifepristone REMS Program to place restrictions on the drug’s distribution and use. Specifically, it implemented an in-person dispensing requirement where the drug may only be dispensed in a clinic, medical office, or hospital through direct supervision of a certified clinician. This prohibited mifepristone from being sold in retail pharmacies or through the mail. The drug’s restrictions were criticized for creating barriers to patient access for medicated early-stage abortions and management of pregnancy loss. Additionally, those that opposed the restrictions claimed its implementation disproportionately harmed minority groups and communities that faced structural barriers to reproductive care. This accelerated throughout the COVID-19 pandemic, and advocacy efforts spearheaded by the American College of Obstetricians and Gynecologists pushed the FDA to reform the REMS program.

In 2021, the FDA completed a review of the REMS Program and set to modify the restrictions to help improve patient access and create efficiencies in health care delivery. Implementations of the Program’s modifications were halted until the FDA approved mifepristone’s updated prescription information by their manufacturer, resulting in the implementations officially going into effect on January 3, 2023. The FDA’s update removed the in-person dispensing requirement and a new pharmacy certification process was added that allows certain retail pharmacies to dispense mifepristone directly to patients who have a prescription. Additionally, given the impact of the Dobbs decision, this update will affect clinic practices based on the abortion laws and regulations of the state that the practices reside in.

Following the FDA’s updated policy, stores like Walgreen and CVS planned to offer mifepristone through their pharmacies in the states that legally allow abortions. However, on March 3, 2023, Walgreens publicly stated it would not be dispensing mifepristone in 20 states after being threatened by public officials. Headed by Missouri Attorney General Andrew Bailey with other attorney generals from Republican run states, a warning letter was issued to CVS and Walgreens on February 1, 2023. The letter alleged abortion pills sold through the mail would be federally illegal based on the Comstock Act, claiming the Act includes language that prohibits the mailing of articles designed to prevent conception or induce an abortion.

In early January of 2023, the Department of Justice (DOJ) noted that the Comstock Act does not prohibit abortion pills being mailed when those sending the pills lack intent that the drugs will be used for illegal purposes; however, Bailey argued against the DOJ and claimed the text of the Act is what governs, not “the Biden administration’s view.” Bailey further threatened CVS and Walgreens with civil litigation through either state attorneys or private citizens.

Walgreen’s announcement affects states where medication for abortions is legal, such as Alaska, Iowa, Kansas, and Montana. In a statement, Walgreens specified that once it was certified by the FDA to sell the abortion pill, the company will dispense the drug complaint to state and federal laws. The threat to selling mifepristone has opened a larger question about state authority in regulating FDA approved drugs and medicated abortion access. Since Walgreen’s announcement, activists have pushed to boycott Walgreens. Currently, there are 2 lawsuits arguing that states do not have the authority to regulate FDA approved drugs; one targeting a state’s restriction on abortion pills, and the other challenging West Virginia’s state abortion ban. If the court rules in favor of the plaintiffs in these cases there may be grounds to claim that FDA policy trumps state law on abortions, but more time is needed to determine the outcome of bans on the abortion pill through state and federal action.

While research and education regarding domestic violence and abuse continues to grow, domestic violence remains a prevalent issue accounting for roughly ten million victims per year in the United States. National statistics show that on average, twenty people per minute are victimized by domestic violence, with roughly one in four women and one in nine men suffering either physical or mental abuse by their partner. Additionally, one in four women and one in seven men are abused through severe physical violence such as beating, burning, or strangulation throughout their lifetime by an intimate partner. While abused individuals are at risk for various physical, mental, sexual, reproductive, and substance abuse issues, only thirty four percent of victims receive medical care for their injuries. 

There are social stigmas surrounding disclosure of abuse from victims for fear of additional harm by their abuser and judgment by society, making domestic violence hard to measure. Previous studies have found that forty four percent of victims have talked to someone about their abuse, with only thirty seven percent of those individuals disclosing their abuse to a healthcare provider. 

Many state and federal laws have required individuals working in a professional capacity to report signs of possible abuse regardless of the patient’s disclosure. Majority of these statutes specify health professionals such as therapists, nurses, and doctors as mandated reporters for domestic violence. State legislation typically falls into four categories: requiring reporting of injuries caused by weapons; reporting injuries that are caused as a result of violence, through non-accidental means, or in violation of criminal law; specifically addressing domestic violence reporting; or there is no general requirement related to mandatory reporting. However, with difficulty around accurately measuring rates of domestic abuse, it is hard to discern if areas with mandated reporting laws truly assist victims, or if they create an additional risk and barrier to those that have not personally disclosed their abuse. 

Two large discussions on mandatory reporting for health professionals include the effectiveness of reporting in maintaining victim’s safety and the victim’s rights to medical privacy. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) addresses privacy protection issues between health care professionals and their patients. However, when health professionals observe clear signs of abuse, especially when they feel the patient is in danger, abuse must be reported. Regardless of a victim’s request to remain confidential, HIPAA does not cover protected health information if a crime has occurred. HIPPA does not prohibit law enforcement officers from gaining access to patients who were victims of a crime and allows officers to obtain information directly from a patient if it relates to a crime.

Many patient visits of domestic abuse victims do not meet the standards for mandatory reporting. For instance, visits related to extreme harm like stab wounds or gun shots would require a report. However, visits associated with abuse, like chronic health conditions of memory loss or depression, would not constitute a report. During these appointments, patients may describe and disclose forms of domestic abuse, but depending on local laws, health providers may not be required to disclose the abuse that is reported to them.

Despite these mandates, one study notes that most primary care physicians do not routinely screen for signs of abuse. Though screening is separate from reporting, two thirds of women who have been abused said they would have wanted their health professional to ask about domestic abuse . Contrastingly, with various state laws, there is a misconception as to what health professionals must report. Particularly with minority or undocumented victims, individuals avoid seeking medical care because they fear the abuser will find out or that deportation agencies will be contacted. Nevertheless, health professionals remain cautious in their reports, hoping that patients will continue to seek care without fear of a privacy breach.

Ultimately, applying mandatory reporting laws creates a fine line between help and harm. Professionals continue to try and decrease domestic violence, but with the understanding that some patients may experience increased harm; alternative measures and a harsh analysis of local laws must be used to provide patient safety. Possible solutions include amending law to refer patients to professionally trained domestic and sexual violence services instead of to the police.