FDA permanently lifts in-person requirements for dispensing abortion pills
Since the pandemic began, the FDA has allowed women to access the abortion drug mifepristone via the mail, making it easier for them and ensuring that they don’t have to go to a clinic to receive the pills.
The FDA’s temporary change became permanent on Thursday afternoon, with the FDA announcing that the REMS on mifepristone (brand name Mifeprex) and its generic versions must be modified by removing this in-person dispensing requirement.
“Removing the in-person dispensing requirement will allow, for example, dispensing of mifepristone by mail via certified prescribers or pharmacies, in addition to in-person dispensing in clinics, medical offices, and hospitals as currently outlined in the Mifepristone Rems Program,” the FDA said.
The permanent change is a win for abortion rights groups in a time when there may be some big changes coming around Roe v. Wade, with the Supreme Court weighing in on a major challenge.
Anti-abortion groups raised questions about the safety of the change from FDA. And the agency, while acknowledging that it hasn’t identified any new safety signals, has received reports of serious adverse events in women who took mifepristone. As of June 30, there were reports of 26 deaths of women associated with (not necessarily caused by) mifepristone since the product was approved in September 2000. A summary report of those FDA data is here.
Acting FDA commissioner Janet Woodcock previously noted in April that based on a review of the medical literature, there weren’t “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.” She also noted that the remaining requirements of the drug’s REMS still need to be met.
The newly updated REMS makes clear that mifepristone must be prescribed by or under the supervision of a certified healthcare provider who meets certain qualifications, the healthcare provider must obtain a signed form from the patient after counseling and prior to prescribing mifepristone, and the pharmacies that dispense mifepristone must be certified.
According to the Guttmacher Institute and the CDC, abortions with mifepristone account for about 40% of all abortions in the US, and 339,640 medication abortions were provided in non-hospital facilities in 2017, a 25% increase from 2014.
Mifepristone is approved by the FDA, in a regimen with misoprostol, to end a pregnancy through 70 days, or about 10 weeks gestation.
The Supreme Court is weighing in on a Mississippi law — which it’s likely to uphold, as all six Republican-appointed justices suggested that they would uphold it — that bans abortion after 15 weeks of pregnancy. According to the New York Times, only 4% of abortions happen after 15 weeks.
“With Roe v. Wade hanging by a thread, it is especially urgent that the federal government do everything in its power to expand access to this medication,” Julia Kaye, a staff attorney for the American Civil Liberties Union, told the Washington Post.