In today’s post-Roe world, women living in states where abortion is illegal have begun to search for alternative options when seeking abortion services. Regulatory policies and state laws, which have not previously had to account for these alternatives, are now impacted by the unprecedented means being used to increase access.
At present, more than half of the abortions in the United States are performed using mifepristone and misoprostol (“the abortion pill”) since the Federal and Drug Administration (FDA) approved its use for women taking the pills up to ten weeks following their last menstrual period. When taken together, the pills are 98% effective. Despite their known safety and effectiveness, the FDA’s drug and safety programs, also known as the Risk and Evaluation Mitigation Strategy (REMS) protocols, impose the same dispensing and distributing restrictions typically associated with high-risk drugs.
Before the pandemic, REMS protocols required women to have an in-person consultation with their healthcare provider before receiving the pills. Despite FDA approval for the use and method of medication abortion, many state laws prevent access to the abortion pill with specific regulations and exceptions. Fourteen states criminalize prescribing and dispensing the medication; fifteen states have targeted regulation of abortion providers laws (TRAP). Specifically, the TRAP laws require in-person waiting periods, an ultrasound, in-person counseling, or the clinician to be present with the patient during the ingestion of the abortion pill.
In light of the chilling effect requiring in-person visits had on receiving essential healthcare during the pandemic, the FDA temporarily lifted this requirement. In December 2021, the requirement was permanently lifted. As a result, it opened the market for online telemedicine abortions in states where abortion is legal. Telemedicine is the use of digital technologies to access healthcare services outside of traditional, in-person medical settings. Despite the evolution of telemedicine during the pandemic, and the FDA’s lifting of restrictions, states can continue to restrict abortion services through the TRAP laws which have rendered telemedicine abortions futile.
Less than 25% of the states permit telemedicine and abortion. Because telemedicine services are defined and regulated by states, providers must comply with state definitions of telemedicine. Significantly, some states require that patients have an established relationship with practitioners via initial in-person visits before receiving telemedicine services. Although many states waived this requirement during the public health emergency declared in January 2021, women seeking telemedicine abortion could not access care during that time because many did not have an established provider relationship.
As a result, this highlighted another area of concern for providers offering telemedicine abortion across state lines. In general, because providers must be licensed in the state where the patient is located and the laws of that state govern, some state laws require patients to verify, and even authenticate, their location to prevent providers from criminal or civil liability in states that prohibit abortion or have “aiding and abetting” laws.
While telemedicine abortion has been identified as a safe and effective option for women seeking medication abortion, providers are limited in their ability to offer FDA-approved services without adequate legal protections. To continue telemedicine abortion without fear of legal and professional ramifications, state legislatures and attorneys general in states such as Massachusetts, Delaware, New York, New Jersey, and Connecticut have enacted shield laws to protect providers providing abortion care to patients living in states where it is restricted.
It is possible that regulatory policies and laws focusing on increasing access to telemedicine abortion may significantly shape the future of reproductive healthcare.