Abortion Drug Safety Clinical Trials, By Mail

In December, the Supreme Court overturned a lower court ruling that allowed the mailing of abortion drugs. Since then, women seeking to terminate a pregnancy with the combination drug package containing mifepristone and misoprostol must now go, in person, to a medical provider.

But this requirement in person is not necessary in many states and in Washington, D.C. As of March 2016, a study has been underway to track participants who used the drugs and to assess the safety and tolerability of the drugs. The trial sponsor is Gynuity Health Projects; the trial completion date listed on clinicaltrials.gov is June 2022. Participating states are listed here.

This medical abortion clinical trial is called TelAbortion. Tara Shochet, project director, told Medical Daily that “TelAbortion is an FDA-approved study to assess the safety, efficacy and feasibility of providing medical abortion using telemedicine and mail. The study operates within the framework of a [investigational new drug] with the FDA, which allows study sites to ship the drugs to study participants.

The safety data from the TelAbortion study may warrant the removal of mifepristone from the FDA’s hazardous drug list called REMS. A drug that lands on the REMS, or Risk Assessment and Mitigation Strategy, does so because it is suspected of causing serious harm.

Due to REMS, mifepristone is not available at any retail pharmacy in the United States. It is only available through a certified provider at a clinic, doctor’s office or hospital. Although some states allow mifepristone to be mailed, drugs on the REMS list are subject to federal law.

Vendors participating in the trial must be licensed to operate under the laws of their state. Ms. Shochet pointed out that TelAbortion does not violate the recent Supreme Court ruling. She explained that “providers cannot register to participate in the study, and the FDA restriction prohibiting the shipment of mifepristone applies nationwide.”

TelAbortion has 9 partner sites that provide TelAbortion services in 17 states and Washington, DC. She added that TelAbortion does not provide services in any state outside of those located in approved study locations.

Refuse a REMS list

The FDA put mifepristone on its REMS list when it was first approved in 2000. A review of studies from that time seems to suggest that taking this combination no later than 9 weeks gestation has no only reduced effectiveness, but caused serious medical problems. A 2005 study who looked at adverse events discussed viability in the second trimester, which begins well past the currently prescribed less than 10-week threshold. There was no breakdown as to when adverse events occurred.

However, a 2015 study of 13,373 women, who did not exceed 63 days of gestation, or 9 weeks, indicated that the rate of infected women requiring hospitalization was 0.01%; for transfusions, 0.03%. The 2005 study, which looked at 607 events involving mifepristone over a four-year period, found 513 cases requiring surgery and 43 cases requiring parenteral antibiotics.

In 2016, the FDA amended the original approval indication for mifepristone by lowering the gestational age for its use and changing the dose allocation.

Today many suppliers think REMS is unnecessarily restrictive because there are now over 20 years of data. Daniel Grossman, MD, director, Advancing New Standards in Reproductive Health at the Bixby Center, University of California, San Francisco, told Medical Daily “there is no medical reason to require patients to visit in person in a clinic to receive pills for abortion medication, especially because patients are not required to take their medications at the office.This requirement creates a barrier to care and increases the risk of transmission of the coronavirus during the pandemic. NEJM reported that in 2016, mifepristone was used by more than 3 million women in the United States with 19 deaths reported to the FDA. Meanwhile, pregnancy-related deaths in the United States are 14 times higher. In 2018 there was 17 maternal deaths per 100,000 live births – almost 32% of all births in 2018 took place caesarean section.

The distribution of pregnancy-related deaths in 2018:

  • Nearly 33% occurred during pregnancy
  • 17% occurred on the day of delivery
  • 52% occurred after childbirth due to infection, hemorrhage, etc.

Participation in the trial

For a woman to be eligible as a participant, the pregnancy must be less than 10 weeks old and verified by ultrasound, which can be done locally. There is a video appointment between the patient and the provider. Then, if the woman is approved as a trial participant, the pills are mailed out and must be taken while the pregnancy is less than 10 weeks away.

Ms Shochet said the pills had been mailed to around 1,500 study subjects since the project began in 2016.

There are several reasons why someone would choose medical abortion, especially during the pandemic. P rivalry and controlling the timing of abortion are two reasons why women seek medical abortions.

Current information suggests that the health risks associated with pregnancy and childbirth outweigh the risk of medical abortion. Removing mifepristone from REMS has the potential to increase access to a safe and effective alternative to early abortion in unplanned pregnancy.

Scheduling an appointment with an abortion provider often includes arranging time off from work and childcare. Other barriers mentioned in obtaining a medical abortion include transport and travel costs.

Yvonne Stolworthy MSN, RN graduated as a nurse in 1984 and has spent many years in critical care and as an educator in a variety of settings including clinical trials.

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