Attorney General Tong Sues FDA Over Unlawful, Unnecessary Restrictions on Medication Abortion Drug
Lawsuit accuses the FDA of ignoring more than a quarter century of science showing that mifepristone is extremely safe
(Hartford, CT) -- Attorney General William Tong today joined a multistate federal lawsuit against the U.S. Food & Drug Administration (FDA) accusing it of singling out one of the two drugs used for medication abortions for excessively burdensome regulation, despite ample evidence that the drug is safer than Tylenol.
The attorneys general also filed a preliminary injunction asking the court to halt the enforcement of the FDA’s restrictions on mifepristone while the case continues.
“Mifepristone is safer than Tylenol. Despite that, the FDA imposes needless restrictions reserved for some of the highest risk drugs, including fentanyl. Some of these restrictions involve unnecessary data collection and certifications that can frighten patients and prescribers concerned about privacy and safety. Our suit seeks to block these unnecessary and unlawful restrictions and to ensure that regulation of medication abortion is based strictly on science and safety,” said Attorney General Tong.
Of the more than 20,000 drugs approved by the FDA, only 60 — including mifepristone — fall under a unique set of restrictions known as Risk Evaluation & Mitigation Strategies, or REMS. REMS restrictions are supposed to apply to inherently dangerous drugs, including opioids like fentanyl, and high-dose sedatives used by psychiatric patients, among others.
The FDA-approved regimen for medication abortion involves a dose of mifepristone, followed by a second drug, misoprostol. To prescribe mifepristone, health care providers must be specially certified by the drug distributor in advance. To receive the prescription, patients and providers must sign an agreement that certifies the patient has decided to take the drugs to end their pregnancy — regardless of whether they are seeking an abortion or are being treated for a miscarriage, which is another common use for mifepristone. A copy of this agreement must be included in the patient’s medical records. To dispense mifepristone, pharmacies must also be specially certified before they can fill a prescription.
The lawsuit asserts the restrictions on prescribing and dispensing mifepristone are unduly burdensome, harmful and unnecessary, and expose providers and patients to unnecessary privacy and safety risks. The risks are exacerbated by the growing criminalization and penalization of abortion around the country in the wake of the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health. The Dobbs case overturned nearly a half-century of precedent, stripping away the constitutional right to abortion recognized by the court’s Roe v. Wade decision.
Disclosure of a provider’s or pharmacy’s certification to prescribe mifepristone, or a patient’s agreement to receive it, all required by the FDA, could expose them to violence, harassment or abuse. This documentation may also be used to threaten providers or patients with legal liability in states with extreme anti-abortion laws.
The FDA approved mifepristone for use in the United States in combination with misoprostol for medication abortions in 2000. Before its approval in the U.S., mifepristone was widely used in Europe, beginning in France in the late 1980s. Since its FDA approval, mifepristone has been safely used more than 5 million times in the U.S.
The FDA itself has acknowledged that “serious complications have proven to be extremely rare” with mifepristone. In the lawsuit, the attorneys general note that mifepristone is associated with fewer serious side effects and deaths than common drugs like Tylenol or Viagra — neither of which are regulated under REMS restrictions.
According to the FDA, not one single death can be attributed to mifepristone during its entire history of use in the United States.
Despite mifepristone’s extremely strong safety record, the FDA has repeatedly declined to remove the REMS restrictions on the medication.
The FDA’s restrictions on mifepristone create unnecessary risk for medical providers, patients and people who travel to other states to receive abortion care.
While safeguards exist to protect the privacy of medical records, the patient agreement documentation required by the FDA creates an added risk for patients who travel 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.
Abortion providers have also 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.
The FDA’s strict requirements also hamper access to safe reproductive care. The certification requirement for providers and pharmacists opens them up to potential liability if they serve patients from other states that have restrictive abortion laws, even if the provider is in full compliance with their state’s laws. And the administrative burdens associated with becoming specially certified deter health care providers and pharmacists from signing up to prescribe and dispense mifepristone in the first place.
In addition, health care 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.
Today’s lawsuit asserts that the FDA exceeded its authority by continuing its unnecessary and extremely burdensome restrictions on mifepristone. The lawsuit also asserts that the FDA’s actions violate the constitutional principle of equal protection.
The lawsuit asks the court to find the FDA’s REMS restrictions unlawful and to bar the federal agency from enforcing or applying them to mifepristone. It also seeks to ensure that mifepristone remains accessible, as a safe and effective drug that Americans commonly rely on.
The lawsuit, led by Washington Attorney General Bob Ferguson and Oregon Attorney General Ellen Rosenblum, was filed in U.S. District Court for the Eastern District of Washington and was joined by Nevada, Delaware, Arizona, Illinois, Colorado, Vermont, New Mexico, Michigan and Rhode Island.
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