WASHINGTON (AP) — Patients seeking an abortion pill do not need to visit a doctor’s office or clinic during the COVID-19 pandemic, U.S. health officials said Tuesday in the latest reversal in an ongoing lawsuit over the drug.
The Food and Drug Administration announced the policy change in a letter to the American College of Obstetricians and Gynecologists, one of several medical groups that have sued over the restriction introduced under the Trump administration.
The Acting Director of the FDA, Dr. Janet Woodcock said a regulatory review of recent studies “does not appear to show an increase in serious safety concerns” when patients take the pill without first visiting a healthcare facility and discussing the drug’s potential risks, including internal bleeding.
The change paves the way for patients to receive a prescription for the pill – mifepristone – via telemedicine and receive it in the mail. But anti-abortion activists are pushing for legislation in several Republican-run states that would prevent easier access.
Medicated abortions have been available in the United States since 2000, when the FDA approved the use of mifepristone. Together with a hormone blocker called misoprostol, it forms what is known as the abortion pill. About 40% of all abortions in the US are now performed through drugs — rather than surgery — and that option has become more important during the COVID-19 pandemic.
Last year, the FDA waived personal requirements for virtually all drugs, including tightly controlled drugs like methadone. However, the FDA and its parent health authority argued that the rules are necessary to ensure the pills are used safely. The rule requires patients to pick up the single mifepristone tablet at a hospital, clinic, or doctor’s office and sign a form that provides information about the drug’s potential risks.
The group of obstetricians and gynecologists sued to overturn the rule, sparking a series of conflicting court decisions. Most recently, in January, the Supreme Court sided with the Trump administration to reinstate the long-standing rule of receiving the drug in person.
The group of obstetricians said in a statement Tuesday the FDA’s about-face on the requirement shows “it is arbitrary and does nothing to enhance the safety of an already safe drug.”
The FDA policy applies only during the COVID-19 public health emergency. Several medical groups are pushing to make medical abortions permanently available through online prescription and mail-order pharmacies.
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