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Gynuity Celebrates Decision by the U.S. Food and Drug Administration to Loosen Regulations on Mifepristone

The U.S. Food and Drug Administration (FDA) announced late yesterday permanent changes to regulations that place unnecessary and burdensome constraints on where, and by whom, mifepristone can be dispensed. The agency’s decision to relax in-person dispensing requirements allows for delivery of abortion pills by mail.

Gynuity Health Projects has long been working towards this day. Our TelAbortion study -- conducted under an Investigational New Drug with the FDA and launched in 2016 when medical abortion by telemedicine was a newly emerging idea with little documentation -- has demonstrated that abortion-seekers can be counselled remotely and receive the medications through the mail in a safe, efficacious and acceptable service. The evidence to support this long-awaited policy change would not have been possible without our dedicated clinical partners across the U.S.

Our paper summarizing the expansion of the TelAbortion study during the COVID-19 pandemic demonstrated that outcomes are comparable to in-clinic care and the service is highly effective. This paper was the primary source cited in the FDA’s April 2021 decision to suspend the in-person mifepristone dispensing requirement for the duration of the pandemic (see here).

Despite mifepristone’s excellent safety and efficacy record, restrictions have remained in place in some form since the drug was first introduced in the U.S. in 2000. In May 2021, the FDA stated its intention to conduct a review of the mifepristone Risk Evaluation and Mitigation Strategy (REMS), a program reserved for drugs with serious safety concerns.

Published Research from the TelAbortion Study

  • Chong et al. Expansion of a direct-to-patient telemedicine abortion service in the United States and experience during the COVID-19 pandemic. Contraception. 2021 Jul;104(1):43-48. doi: 10.1016/j.contraception.2021.03.019. Epub 2021 Mar 27. PMID: 33781762.
  • Raymond et al. TelAbortion: Evaluation of a direct to patient telemedicine abortion service in the United States. Contraception. 2019 Sep;100(3):173-177. doi: 10.1016/j.contraception.2019.05.013. Epub 2019 Jun 4. PMID: 31170384
  • Anger et al. Clinical and service delivery implications of omitting ultrasound before medication abortion provided via direct-to-patient telemedicine and mail. Contraception. 2021 Jul 28:S0010-7824(21)00342-5. doi: 10.1016/j.contraception.2021.07.108. Online ahead of print. PMID: 34329607
  • Kerestes et al. "It was close enough, but it wasn't close enough": A qualitative exploration of the impact of direct-to-patient telemedicine abortion on access to abortion care. Contraception. 2021 Jul;104(1):67-72. doi: 10.1016/j.contraception.2021.04.028. Epub 2021 Apr 30. PMID: 33933421
  • Raymond et al. "False positive" urine pregnancy test results after successful medication abortion.Contraception. 2021 Jun;103(6):400-403. doi: 10.1016/j.contraception.2021.02.004. Epub 2021 Feb 14. PMID: 33596414
  • Beardsworth et al. Miles and days until medical abortion via TelAbortion versus clinic in Oregon and Washington, USA. BMJ Sex Reprod Health. 2021 Mar 31:bmjsrh-2020-200972. doi: 10.1136/bmjsrh-2020-200972. Online ahead of print. PMID: 33789954