“No one should have to navigate medically unnecessary obstacles in order to get essential, time-sensitive health care—particularly during a pandemic. … The administration must act now to ensure everyone can safely access medication abortion care during the pandemic, as well as after it ends.”
Last Thursday, 55 reproductive health, rights and justice groups sent a letter to President Biden urging his administration to lift U.S. Food and Drug Administration (FDA) restrictions on the abortion pill mifepristone. Along with this letter, they delivered petitions with over 200,000 signatures of supporters.
NARAL, Planned Parenthood Federation of America, the ACLU and many other groups condemned the Trump administration decision still in place that many interpret to require people to travel in-person to a clinic just to pick up the medication—an outdated requirement that is especially dangerous during the pandemic.
“The Biden administration promised to follow the science. In this case it couldn’t be clearer: The FDA’s restrictions on medication abortion are unnecessary, outdated, and only serve to obstruct access to care, further deepening health inequities for those who are struggling most,” said Georgeanne Usova, senior legislative counsel at the ACLU.
Approved by FDA for use during the first ten weeks of gestation, medication abortion uses two types of pills: mifepristone, which interrupts the flow of the hormone progesterone that sustains the pregnancy, and misoprostol, which causes contractions to expel the contents of the uterus. This combination of pills is more than 95 percent effective and is a safe way to end an early pregnancy.
Despite its safety, the FDA has imposed politically-motivated anti-abortion restrictions on the distribution of mifepristone by prohibiting retail pharmacies from stocking and distributing mifepristone and requiring that the medication be dispensed only in certain health care facilities through a certified prescriber. Providers and some courts have interpreted the word “dispensed” to require patients to make an in-person visit to their clinicians to obtain the pill, which they can then ingest at home. The advocacy group Plan C disputes this interpretation, noting that the language of the FDA restriction does not specify “in-person” dispensing or prohibit clinicians from mailing pills to patients.
Abortion access advocates have challenged this FDA restriction in courts both before and during the pandemic. Last July a federal district court in Maryland struck down the restriction as an undue burden on abortion access during the pandemic, but the U.S. Supreme Court reinstated the restriction in January.
The safety of mifepristone is well-documented. A new study published in Obstetrics and Gynecology found that medication abortion care with mifepristone dispensed by pharmacists is effective with a low prevalence of complications, and patients are satisfied with pharmacists dispensing the medication. Recent research out of the U.K. based on a real-world study of a national population found that in-clinic and telemedicine abortion were equally safe, with similar, very low rates of serious adverse events (0.02 percent vs. 0.04 percent). In fact, mifepristone is safer than many drugs that the FDA allows to be distributed without these restrictions.
Last March, a coalition of 21 state attorneys general led by California Attorney General Xavier Becerra sent a strongly-worded letter to the U.S. Department of Health and Human Services and its FDA, urging the agency to waive enforcement of its REMS designation during the pandemic.
“As communities across the nation shelter in place to help prevent the spread of COVID-19, we must ensure that women can continue to safely access essential health services including safe and legal abortion,” said Attorney General Becerra, whom on Friday the Senate confirmed to head HHS. “Forcing women to unnecessarily seek in-person reproductive healthcare during this public health crisis is foolish and irresponsible. That’s why we’re calling on the Trump Administration to remove red tape that makes it more difficult for women to access the medication abortion prescription drug.”
Only one Republican—Senator Susan Collins (R-Maine), voted to confirm Becerra’s nomination.
On February 9 of this year, members of the House Committee on Oversight and Reform wrote a letter to FDA requesting it lift the in-person requirement for medication abortion care.
Meanwhile, abortion opponents are spreading misinformation about the abortion pill, which they call “chemical abortion.” They claim that the abortion pill poses “profound dangers” to women. In fact, mifepristone is an extremely safe medication. Last September, nearly a hundred Republicans from each chamber of Congress urged the FDA to take the drug off the market entirely.
Thursday’s letter frames abortion pill access as a racial and economic equity issue:
“Burdensome restrictions on medication abortion, which are not based in medical evidence, deepen the health inequities already experienced by those who are struggling to make ends meet, particularly people of color, who comprise a majority of medication abortion patients and are now being hit hardest by the COVID-19 pandemic.”
In asking Biden to prioritize safe access to medication abortion, the letter reminds Biden of his promise to address issues of systemic equity across the government.
“No one should have to navigate medically unnecessary obstacles in order to get essential, time-sensitive health care—particularly during a pandemic, when that means risking needless exposure to a deadly virus,” said Usova of the ACLU. “The administration must act now to ensure that everyone can safely access medication abortion care during the pandemic, as well as after it ends.”
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