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Federal court rules FDA must suspend physical visit restriction on early abortion medication
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Federal court rules FDA must suspend physical visit restriction on early abortion medication

The US District Court for the District of Maryland issued a preliminary injunction Monday that temporarily stops the US Food and Drug Administration  (FDA) from restricting access to mifepristone, an early abortion medication. The FDA had previously required patients to physically travel to their health care providers to pick up the medication and sign a form, a practice that the district court has decided to halt because of COVID-19.

Typically, mifepristone can only be dispensed to patients in certain environments, which the FDA restricted to clinics, medical offices, or hospitals. The FDA also required patients to sign the Patient Agreement Form in the physical presence of a certified healthcare provider. The healthcare provider then had to provide the patient with a physical copy of the form at a clinic, medical office, or hospital.

The court ruled that the medication can now be dispensed by mail or delivery service, although it must occur by or under the supervision of a certified healthcare provider. Patients can now also sign the Patient Consent Form physically or electronically during an online medical session with a certified healthcare provider. The patient can then return the form electronically or by mail. Alternatively, a patient can give oral consent to the terms of the form during the online medical session, which the healthcare provider would then document in the patient’s record. The healthcare provider is also allowed to provide a copy of the form either electronically or by mail.

Once the plaintiffs post a bond of $1,000, pursuant to the Federal Rules of Civil Procedure 65(c), the preliminary injunction will take effect. The injunction will last until 30 days after the end of the COVID-19 public health emergency.