FDA Announces Repeal of Outdated Restriction on Medication Abortion

Responding to an ACLU Lawsuit, the Long-Sought Announcement Comes Days After Supreme Court Gave States the Green Light to Effectively Ban Abortion

Affiliate: ACLU of Hawaii
December 16, 2021 4:45 pm

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WASHINGTON — The U.S. Food and Drug Administration (FDA) announced today the permanent repeal of a medically unnecessary restriction requiring that mifepristone, a drug used in early abortion and miscarriage care, be dispensed to patients in person at a hospital, clinic, or medical office. The agency’s announcement comes in response to a case filed in 2017 by the American Civil Liberties Union on behalf of abortion providers and medical groups. Today’s announcement will secure access to mifepristone for abortion and miscarriage patients in many states across the country. The FDA’s decision comes at a crisis moment for reproductive freedom after the Supreme Court last week in the Texas SB 8 case gave states the green light to effectively ban abortion, and as the court seems poised to soon overrule or dramatically undermine Roe v. Wade. However, the FDA retained several baseless restrictions that continue to single out mifepristone despite its excellent safety record.

In a letter to the plaintiffs, the FDA announced that it would repeal a medically unnecessary, outdated requirement that forces patients to pick up mifepristone in person at a medical facility, making permanent its COVID-related policy allowing patients to temporarily receive the medication by mail or delivery. This in-person requirement has long singled out mifepristone patients for no medical reason: until now, mifepristone was the only medication out of 20,000 FDA-approved drugs that patients were required to pick up at a medical facility even though they were permitted to take it at the location of their choice. Unfortunately, the FDA failed to listen to the calls from our nation’s leading medical authorities to remove a requirement that patients sign a special form in order to be prescribed mifepristone, as well as a requirement that health care professionals be specially certified in order to prescribe it — an unnecessary hurdle that blocks many patients from accessing this medication from their own qualified health care providers. The FDA has not yet announced when today’s announcement will become effective.

For more than 20 years, mifepristone has offered an exceedingly safe and effective, FDA- approved means of ending a pregnancy; and more recently, high quality medical research has also confirmed its important role in helping to treat miscarriage. Nevertheless, the agency has maintained a set of unique and outdated restrictions on mifepristone, called the Risk Evaluation Mitigation Strategy (REMS). With no safety benefit, these restrictions have only served to block access to essential health care and disproportionately harm people who already face severe health disparities and barriers to accessing health care — including people of color, people struggling to make ends meet, and people living in rural areas.

“The FDA’s decision to permanently remove the in-person pill pick-up requirement is a major step forward that will enable many more patients to get this safe and time-sensitive medication as soon as they are ready, without travel-related expenses and delay. From the person living in a rural community hundreds of miles from the nearest clinic to the patient who wants to access this essential care in the privacy and comfort of their home, the FDA’s decision will come as a tremendous relief for countless abortion and miscarriage patients. However, it is disappointing that the FDA fell short of repealing all of its medically unnecessary restrictions on mifepristone and these remaining obstacles should also be lifted,” said Georgeanne Usova, senior legislative counsel at the ACLU.

“The FDA’s decision eliminating its unnecessary in-person requirement did not come a moment too soon, as politicians emboldened by the Supreme Court’s shameful decision in Texas race to impose ever more barriers and burdens on people seeking to end a pregnancy, with outsized harm to communities of color,” said Julia Kaye, staff attorney with the ACLU Reproductive Freedom Project and counsel for plaintiffs. “With states banning abortion at earlier and earlier points in pregnancy, it is all the more essential that the FDA remove medically unnecessary restrictions that reduce where and how patients can safely fill their mifepristone prescription — and today’s decision is critical progress, though far from complete. We will continue to fight every day for a world where we can all control our reproductive destinies, regardless of where we live, how much money we make, or the color of our skin.”

Leading medical groups — including the American College of Obstetricians and Gynecologists (ACOG), the American Medical Association (AMA), and the American Academy of Family Physicians (AAFP) — have long opposed the FDA’s restrictions on mifepristone because they have no basis in medicine and only create barriers to time-sensitive care. The agency’s announcement comes months after the FDA, in response to a separate lawsuit filed by the ACLU, took a key step forward for science and safety by temporarily lifting the in-person requirement for abortion and miscarriage patients seeking mifepristone during the COVID-19 public health emergency. After today’s announcement, patients who need mifepristone for abortion or miscarriage care will continue to be able to obtain their prescription directly by mail or through a mail-order pharmacy, where permitted by state law.

Separate from these federal restrictions, roughly half of the states impose additional, state-level restrictions on mifepristone, which remain in place. Critically, FDA’s decision will help expand options and capacity in states seeing an influx of out-of-state residents seeking abortion care as a result of abortion bans and restrictions in their home states. Currently, as a result of the Texas six-week abortion ban, neighboring states have extreme wait times for abortion appointments of up to four to six weeks.

The plaintiffs in the case are Dr. Graham Chelius, the Society of Family Planning, and the California Academy of Family Physicians. They are represented by attorneys with the ACLU, the ACLU of Hawaii, and Arnold & Porter Kaye Scholar LLP.

The letter from the FDA can be found here: https://www.aclu.org/letter/fda-rems-review-announcement-letter

The case page can be found here: https://www.aclu.org/cases/chelius-v-becerra

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