Experts see the lawsuit as an attempt to produce a contrary ruling from a Trump-appointed Texas judge, who many predict will order the FDA to remove mifepristone from the market.
As people wait nervously for an anti-abortion judge to rule in a Texas lawsuit aimed at removing the abortion pill mifepristone from the market nationwide, Democratic attorneys general from a dozen states are fighting back with a lawsuit of their own.
On Feb. 24, attorneys general of Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont sued the U.S. Food and Drug Administration (FDA), asking a Washington federal court to declare that mifepristone is safe and effective and that the FDA’s approval of mifepristone is lawful and valid. The attorneys general ask the court to enjoin the FDA from taking any action to remove mifepristone from the market or reduce its availability, and to require the FDA to remove several current restrictions on the medication.
“In this time when reproductive healthcare is under attack, our coalition of 12 states seeks to ensure that access to mifepristone—the predominant method of safe and effective abortion in the U.S.—is not unduly restricted,” said Oregon Attorney General Ellen F. Rosenblum, co-lead counsel with Washington Attorney General Bob Ferguson. “Our coalition stands by our belief that abortion is healthcare, and healthcare is a human right.”
The FDA has placed mifepristone in the Risk Evaluation and Mitigation Strategy (REMS) drug safety program designed to regulate dangerous or addictive drugs, such as fentanyl and other opioids, certain risky cancer drugs and high dose sedatives used for patients with psychosis. The FDA has imposed REMS on only 60 medications out of the more than 20,000 prescription drugs approved for use in the U.S.
Subjecting mifepristone to the REMS program gives the impression mifepristone is a risky or dangerous drug when, in fact, it has been on the market in the United States for over two decades, used 5.6 million times and is very safe—safer in fact than Tylenol.
“The federal government has known for years that mifepristone is safe and effective,” said Ferguson. “In the wake of the Supreme Court’s radical decision overturning Roe v. Wade, the FDA is now exposing doctors, pharmacists and patients to unnecessary risk. The FDA’s excessive restrictions on this important drug have no basis in medical science.”
Our coalition of 12 states seeks to ensure that access to mifepristone—the predominant method of safe and effective abortion in the U.S.—is not unduly restricted.Oregon AG Ellen F. Rosenblum
The mifepristone REMS program requires medical providers prescribing mifepristone to register with the drug manufacturer and requires pharmacies to go through a certification process in order to dispense mifepristone. The REMS also requires patients to sign an agreement attesting that they have chosen to take the medication to terminate a pregnancy, even when they are using the medication for miscarriage.
“FDA’s decision to continue these burdensome restrictions in January 2023 on a drug that has been on the market for more than two decades with only ‘exceedingly rare’ adverse events has no basis in science,” according to the AGs’ complaint. “It only serves to make mifepristone harder for doctors to prescribe, harder for pharmacies to fill, harder for patients to access, and more burdensome for the plaintiff states and their healthcare providers to dispense.”
The plaintiff states argue that the FDA has exceeded its authority by continuing its “unnecessary and extremely burdensome” restrictions on mifepristone, exposing patients to needless anguish and confusion and violating the Fifth Amendment equal protection guarantees of the U.S. Constitution.
“Through the 2023 REMS, FDA reduces access to a critical and time-sensitive healthcare service needed by pregnant people. And FDA treats providers, pharmacists and patients who prescribe, dispense or use mifepristone worse than providers, pharmacists and patients who prescribe, dispense, or use nearly every other medication. FDA’s actions are irrational and violate the Fifth Amendment under any standard of review.”
The states argue that the REMS requirement that providers register with the drug manufacturer could compromise their privacy and safety, result in them being targeted by anti-abortion violence. Abortion opponents made 182 death threats against abortion providers in 2021 alone.
The certification requirement for providers and pharmacies might discourage them from offering mifepristone, especially in light of the increased criminalization of providing abortion services in many states.
“The certification requirement for providers and pharmacists opens them up to potential liability if they serve patients from other states like Idaho that have restrictive abortion laws, even if the provider is in full compliance with Washington law,” according to a press release from Ferguson’s office. “In addition, healthcare providers who may move to other states in the future to practice might think twice about completing a certification to prescribe mifepristone, as it may expose them to liability or professional consequences in the future.”
The lawsuit also objects to the FDA requirement that patients must fill out a patient agreement form, which must be included in their medical records and, and for women from states banning abortion, can be viewed by providers in their home states.
“While safeguards exist to protect the privacy of medical records, the patient agreement documentation required by the FDA creates an added risk for patients—particularly for those patients who travel to Washington for medical treatment from states where their abortion is illegal. The documentation of their abortion remains in their medical records, and can be viewed by providers in their home state,” says Ferguson’s office.
Ferguson expressed concern about hackers compromising the confidentially of these patient agreement forms.
“Abortion providers have been targets for hackers seeking to steal information about both patients and providers. In 2021, for example, hackers accessed data roughly 400,000 patients from Planned Parenthood Los Angeles. Providers in Washington report frequent cyber attacks aimed at illegally obtaining information about patients and providers. This is especially concerning because abortion providers and patients can be targeted for harassment and extremist violence.”
According to the AGs’ complaint, “the REMS require burdensome documentation of the patient’s use of mifepristone for the purpose of abortion, making telehealth less accessible and creating a paper trail that puts both patients and providers in danger of violence, harassment and threats of liability amid the growing criminalization and outlawing of abortion in other states.”
FDA’s actions are irrational and violate the Fifth Amendment under any standard of review.
In addition to lifting the REMS restrictions, the lawsuit asks the judge to declare that the FDA’s “approval of mifepristone is lawful and valid” and toblock the FDA fromremoving mifepristone from the market or reducing its availability.
Experts see the lawsuit as an attempt to produce a contrary ruling from the Texas judge, whom observers predict will order the FDA to remove mifepristone from the market. If two federal rulings conflict, then the FDA could refuse to remove the medication from the market until a Supreme Court ruling, preserving access to the medication until that time.
The Washington state lawsuit does not address the other important issue in the Texas lawsuit—the attempt to revive the 1873 Comstock Law to ban mailing abortion pills in the U.S.
The AGs also filed a preliminary injunction asking the court to halt the enforcement of the FDA’s restrictions on mifepristone while the case continues.
Advocates applauded the lawsuit.
“It is time to stop the overregulation of this extremely safe medication,” said Elisa Wells, co-director of Plan C, which provides up-to-date information on how people in the U.S. are accessing at-home abortion pill options online. “We have long known that the FDA’s restrictions on mifepristone are not based on science and create unnecessary restrictions to access of this safe and effective medication. Eliminating the REMS for mifepristone would enable more convenient access through pharmacies, telehealth and primary care providers.”
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