The COVID-19 pandemic shines a light on many important issues of equity, but one lost in the headlines is patient access to medication abortion. Patients who need medication for abortions are not able to access it because the Food and Drug Administration (FDA) put onerous conditions around the prescription of the abortion pill (Mifepristone). There is presently a legal case winding its way through the courts over the past four years, Chelius v. Wright, challenging the FDA’s rules based on its own regulations. One of the conditions the FDA listed is that the drug cannot be prescribed via telemedicine. However, during the pandemic, taking an abortion pill at home is actually safer than going to a clinic where the patient would interact with numerous people.
What is Medication Abortion?
Medication abortion involves two different medications which induce a miscarriage. It can be taken up to 70 days (10 weeks) into pregnancy which is when the vast majority of abortions take place. The patient first takes Mifepristone which causes the embryo to detach from the uterus. One or two days later, the patient takes Misoprostol which causes cramping and bleeding to expel the embryo. Seven to ten days later, the patient returns to the health care provider for either a blood test or a sonogram to make sure the abortion was complete.
Medical Safety, the FDA, REMS, and ETASU
The abortion pill, Mifepristone, was first approved by the FDA in 2000. At that time, the agency placed the drug under the Risk Evaluation and Mitigation Strategy (REMS) category. The agency also placed an Elements to Assure Safe Use (ETASU) measure on the drug. FDA guidelines stipulate that ETASU “may be required if the drug has been shown to be effective, but is associated with a specific serious risk and can be approved only if, or would be withdrawn unless, such elements are required as part of a strategy to mitigate a specific serious risk(s) listed in the labeling of the drug.” However, we now have eighteen years of data that show that Mifepristone is extremely safe. With over 3.7 million patients having taken the drug, adverse events are well under 1%. Patients carrying a child to full term are 14 times more likely to die than a patient taking Mifepristone. Both the American College of Obstetricians and Gynecology and the American Academy of Family Physicians agree that the REMS is unnecessary. Given this data, it is hard to understand why the FDA still keeps the drug in the REMS category.
Listed below are the REMS and ETASU for Mifepristone (Mifiprex is the generic name) followed by the rebuttal argument as to why the REMS designation is harmful.
“Mifeprex must be ordered, prescribed and dispensed by or under the supervision of a healthcare provider who prescribes and who meets certain qualifications*”
It is important that the prescribers are trained in the uses and side effects of any drug prescribed. The “certain qualifications” portion of this element simply means the prescriber has reviewed the drug with the manufacturer and registered with the drug company.
“Healthcare providers who wish to prescribe Mifeprex must complete a Prescriber Agreement Form prior to ordering and dispensing Mifeprex.”
Many doctors are reluctant to be entered into a registry that identifies them as doctors who provide abortion care. The long history of harassment, assaults, and even murder of doctors providing abortion services understandably makes them nervous. By doing away with the registry, the concerns about names being published would be greatly alleviated.
Doctors are also concerned about internal issues with their staff who may not support abortion rights.
Some doctors cannot obtain approval from their hospital or governing institution.
Mifeprex may only be dispensed in clinics, medical offices, and hospitals by or under the supervision of a certified healthcare provider
There is no clear reason as to why a patient would need to come to the clinic to obtain the pills since the patient goes home right after taking the pill. The patient can be given counseling as to how to use the pill either over the phone or through telemedicine.
Obtaining certification takes several weeks for a doctor to obtain. Because pregnancy is a time-sensitive condition, patients do not have the time to wait.
The healthcare provider must obtain a signed Patient Agreement Form before dispensing Mifeprex.
This form can be obtained electronically.
Why should we revisit the telemedicine ban?
The requirement that the drug must be both prescribed and obtained at the provider’s office under the supervision of the provider is the issue that prevents many patients access to the drug. When a patient takes the drug at the clinic or office, she simply leaves the office right afterward with the prescribing information. There is no need for supervision. The pill begins working long after the patient has left the doctor’s office. This begs the question, why does the patient have to go to the doctor’s office to get the pill? This visit could easily be completed via telemedicine. The provider could counsel the patient and have the patient sign the Patient Agreement Form.
What burdens does the REMS designation put upon patients?
The FDA guidelines stipulate that ETASU “must be commensurate with the specific serious risk listed in the drug’s labeling, and must not be unduly burdensome on access to the drug, especially for patients with serious or life-threatening diseases and who have difficulty accessing healthcare.” An examination of each of the elements shows that the FDA’s own guidelines are unnecessary.
We have already established that Mifepristone does not pose a serious risk. In fact, staying pregnant is much riskier from a health standpoint.
Women in rural and underserved areas do not have access to clinics and doctors who provide abortion medication. Many patients have to drive hours to a clinic that provides Mifepristone. One of the plaintiffs in the lawsuit mentioned earlier is a doctor in Hawaii whose patients must take a plane to obtain abortion services. If primary care doctors were able to prescribe Mifepristone, then patients could obtain the medication more easily
How does this relate to the COVID-19 pandemic?
During this pandemic, many state governments have tried to further curtail access to abortion services. These closures caused women to have drive hours to another state to obtain their abortions. Patients needing an abortion already have to face protesters at the clinics, the receptionist, nurses, and doctors making the entire process much riskier to their health. If the patient could access the doctor through telemedicine and pick up the prescription at the pharmacy, she would avoid all of that unneeded contact. This would be better for the medical staff as well. The issue was raised to the FDA commissioner last month in a letter signed by 21 Attorneys General asking for the REMS designation to be discontinued.
Right to privacy
The irony of the Roe V. Wade decision being based on a woman’s right to privacy juxtaposed against how it has unfolded is not lost on many. Patients seeking an abortion are subjected to protesters yelling and “counseling” them at clinics. Some protesters go so far as to take video and write down license plate numbers to intimidate patients. Can you imagine if some group decided that it was sinful for you to get a physical and harassed you the way these patients are harassed? They deserve the dignity and privacy to access legal healthcare in the simplest and safest manner possible. If patients could simply have a telemedicine conversation with their doctor, pick up their prescription, and go home without having to deal with protesters, it would be a completely different experience. Patients have a right to privacy about their healthcare and should be allowed access to legal and safe medication without the politicians weighing in.