As all eyes are on a landmark Supreme Court hearing on how patients in the US can access abortion pill mifepristone next month, a study has found that it is safe and effective when prescribed and delivered using telemedicine.
The new analysis, published in the journal Nature Medicine, shows that women who received pharmacological abortion using mifepristone and misoprostol after an online consultation and delivery through the mail had similar outcomes to those who are prescribed it after an in-clinic visit.
On 26th March, SCOTUS is scheduled to hear a case brought by the conservative group Alliance for Hippocratic Medicine (AHM) challenging policies adopted by the FDA to expand access to the mifepristone/misoprostol regimen used for abortion, allowing remote consultations and self-reported medical history rather than in-clinic testing to confirm women were eligible.
The case comes against the backdrop of the stripping of the legal right to abortion in the US in 2022, which prompted the FDA to widen access to mifepristone as an alternative to surgical abortion as telehealth became vital to meeting demand for women living in states where abortion has now been banned.
It is also viewed in some quarters as a major attack on the standing and authority of the FDA that could set a dangerous precedent by allowing medicines regulation to be driven by based on political and personal views rather than medical science.
A lower court ruling last year called on the FDA to revoke the two-decades-old license for mifepristone. That was reversed on appeal court, but the upper court also wound back the measures that were introduced by the FDA to make it easier to get access to abortion medication, including telemedicine prescriptions and mail-order availability.
The new CHAT study provides evidence that there is no safety or efficacy reason to restrict telehealth access to mifepristone/misoprostol, according to the researchers behind the work.
Looking at more than 6,000 abortions carried out via telehealth in California, they found that 99.8% of terminations were not followed by serious adverse events and 97.7% were terminated successfully without subsequent intervention – results that are “similar to published rates of in-person medication abortion care.”
They also found that the telehealth channel had no bearing on the outcome, with text-based consultations as effective as phone or video.
The finding is consistent with the FDA’s assessment of the safety of mifepristone and misoprostol. The approved label for the drug indicates a 97.4% success rate in terminating a pregnancy and less than 0.5% risk of a serious adverse event.
“While decades of evidence support the effectiveness and safety of mifepristone provided in person, the evidence supporting no-test direct-to-patient telehealth abortion is more limited,” write the authors, from the University of California, San Francisco (UCSF) and California Latinas for Reproductive Justice, in the paper.
“This research confirms that the FDA followed science in allowing patients to get medication abortion through telehealth and the mail,” said UCSF lead researcher Ushma Upadhyay in a statement.
“Our findings make it abundantly clear that the case at the Supreme Court is simply an attempt to restrict access to abortion care, even in those states where it’s legal.”
Photo by danilo.alvesd on Unsplash
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