SIOUX FALLS, S.D. (KELO) — On December 16, the U.S. Food and Drug Administration (FDA) expanded access to abortion pills, allowing for the medication to be obtained by mail instead of requiring a visit with specific providers. But in South Dakota, this FDA decision may not make a difference.
The purpose of the FDA decision to remove the in-person requirement is to “reduce burden on patient access and the health care delivery system.” The change involves allowing the requirement for the drug mifepristone to be dispensed only within medical offices.
The biggest impact the change has is that it will allow the dispensing of the abortion pills via the mail from certified prescribers or pharmacies. But not in South Dakota.
This is due to a September 7, 2021, executive order issued by Governor Kristi Noem.
In the order, Noem blasted mifepristone as “dangerous drugs” that could cause “potential harm to women in South Dakota,” and called the then proposed lifting of the in-person regulation by the FDA “a dramatic overreach of the executive branch of the Federal government.”
Noem also attacked the means through which these medications would be attained under the new FDA regulations, describing the process as “a loosely regulated system of brick-and-mortar clinics, online pharmacies, video calls, and online evaluation forms.”
According to the FDA, “Mifepristone must be prescribed by or under the supervision of a certified healthcare provider who meets certain qualifications.”
Healthcare providers who would like to become certified to prescribe Mifeprex must have the ability to date pregnancies accurately and to diagnose ectopic pregnancies. Healthcare providers must also be able to provide any necessary surgical intervention, or have made arrangements for others to provide for such care. Healthcare providers must be able to ensure that women have access to medical facilities for emergency care, and must agree to other responsibilities, including reviewing and signing the Patient Agreement Form with the patient and providing each patient with a copy of the signed Patient Agreement Form.FDA
In her order, Noem directed the South Dakota Dept. of Health (DOH) to adopt new rules to:
- Ensure that medicines, drugs, or any other substances prescribed or dispensed with the intent of terminating the pregnancy of a woman shall only be dispensed by a physician licensed in South Dakota to a patient after examining her in-person;
- Provide that no manufacturer, supplier, physician, or any other person may provide any abortion-inducing drugs directly to women in South Dakota via courier, delivery, telemedicine, or mail service;
- Ensure abortion-inducing drugs shall not be dispensed or provided in any school facility or on state grounds, including but not limited to, elementary schools, secondary schools, and institutions of higher education in this state (Noem also contended that “the abortion industry is targeting young women,” and that “school bathrooms are at risk of becoming the new abortion clinics.”);
- Remind licensed physicians dispensing or prescribing abortion-inducing drugs they shall ensure that our state’s Informed Consent laws are properly administered;
- Develop an abortion clinic license specific to the pharmaceutical nature of medical abortion in keeping with South Dakota’s existing surgical abortion clinic licensing requirements (i.e., a license for “pill only” clinics);
- Collect empirical data on how often chemical abortions are performed as a percentage of all abortions, how often women experience complications that require medical follow-up (or a second abortion), where the doctor prescribing or dispensing chemical abortion is located, if she was coerced or sex trafficked and forced to take the pills, and more;
- Enhance reporting requirements for this procedure so that we know how often and how harsh the results are.
A public hearing on the matter was held on December 8, drawing criticism from a Planned Parenthood official, who said the proposed rule would be the most strict in the nation.
The proposal would limit the use of two abortion drugs, Mifepristone and Misoprostol, to the first nine weeks after conception, restrict their use to a licensed abortion facility, require they be prescribed and dispensed only by a licensed physician, and require the patient to make multiple trips to complete a medical abortion.
Reached Tuesday for comment on the availability of abortion pills in South Dakota, a representative from Planned Parenthood North Central States wrote the following:
Governor Noem has made it clear she would like to eliminate access to safe and legal abortion even though South Dakotans overwhelmingly defeated two abortion bans. Telehealth abortions are already illegal in South Dakota and now Noem wants to make it nearly impossible to access medication abortion in the state, taking away a crucial health care option for patients. South Dakotans deserve better, and Planned Parenthood will continue to provide high quality, inclusive, comprehensive sexual and reproductive care for all.Planned Parenthood North Central States
The legislative Rules Review Committee will meet on December 27 to again discuss the implementation of the proposed DOH rules. This proposal would require that:
- No medical abortions by use of Mifepristone and Misoprostol be conducted except in a license abortion facility, with an observation period;
- The pregnant woman be informed that if she changes her mind and decides to carry the baby to term, the effects of the medications maybe reversible; and
- Abortion facilities collect and maintain certain information.