Biden administration signals that FDA may allow abortion pill access via mail even after the pandemic
Biden administration lawyers on Friday told a district court to hold off on deciding a major abortion pill case until December because the FDA may remove a decades-old prohibition on dispensing such pills via mail.
While noting that the FDA temporarily lifted the in-person requirements during the pandemic last month, the Justice Department lawyers said the FDA is now reviewing the risk evaluation and mitigation strategy for the abortion pill, known as Mifeprex (mifepristone). The lawyers said they would provide an update on the FDA’s progress by November.
The American Civil Liberties Union, which originally sued the federal government in 2017 to expand access to the abortion drug and to remove cumbersome rules that might restrict access to it, and the American College of Obstetricians and Gynecologists both praised the announced move by the FDA.
BREAKING: The FDA agreed to conduct a review of its restrictions on mifepristone, a medication used for early abortion and miscarriage care.
After four years of litigation, this is long overdue, but a major move forward.
— ACLU (@ACLU) May 7, 2021
We are thrilled that the @US_FDA is conducting a new, evidence-based review of the burdensome, unnecessary REMS requirements for #mifepristone, including the in-person dispensing requirement that is currently on pause due to advocacy and litigation from @ACOG. 1/
— ACOG Action (@ACOGAction) May 8, 2021
The federal court has yet to decide if it will grant the stay until the FDA completes its review.
Meanwhile, 19 states now require that a clinician be physically present when the abortion drug is administered, thereby prohibiting the use of telemedicine to prescribe medication for abortion remotely, according to the Guttmacher Institute.
But the FDA’s current pause in restricting access to the abortion pill via mail may also generate new data on whether it’s safe.
In announcing the previous change during the pandemic, FDA acting commissioner Janet Woodcock said that based on a review of the medical literature, there does not appear to be “increases in serious safety concerns (such as hemorrhage, ectopic pregnancy, or surgical interventions) occurring with medical abortion as a result of modifying the in-person dispensing requirement during the COVID-19 pandemic.”
If court challenges make their way to the Supreme Court again, the ideological split on the top court may create issues for those seeking to expand access to mifepristone.
Last January, prior to the FDA’s announcement, the Supreme Court came to a 6-3 decision to stop a lower court from waiving the FDA rules that would’ve allowed for the distribution of the abortion pills by mail during the pandemic.