(CN) — Attorneys general from Oregon and Washington state have led the charge against the U.S. Food and Drug Administration, claiming the agency imposed burdensome regulatory actions on mifepristone and misoprostol — two drugs administered in combination for medication abortions.
“The federal government has known for years that mifepristone is safe and effective,” said Washington state Attorney General Bob Ferguson in a statement. “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.”
In 2000, the FDA approved mifepristone under the brand name Mifeprex to be used in combination with the drug misoprostol to end early pregnancies. Mifepristone interrupts early pregnancy by blocking the effect of progesterone, a hormone that maintains a pregnancy, while misoprostol causes uterine contractions that cause miscarriage.
Ferguson and Oregon Attorney General Ellen Rosenblum argue that since then, 5.6 million U.S. women have safely used mifepristone, a drug “safer than many other common drugs FDA regulates, such as Viagra and Tylenol.”
“As [the] FDA acknowledged in 2016, mifepristone has been increasingly used as its efficacy and safety have become well-established by both research and experience, and serious complications have proven to be extremely rare,’” Ferguson says in an 87-page lawsuit filed Thursday, adding how medical abortion represents 60% of all abortions in Washington state.
Yet, despite these arguments, Ferguson claims the FDA’s recent rule change places undue burdens on his state’s doctors, pharmacies and patients by making the drugs harder to access and more dangerous for those traveling from states that have made abortion illegal.
The complaint outlines how the FDA recently singled out mifepristone under a unique set of FDA restrictions known as “Risk Evaluation and Mitigation Strategy,” which the agency may impose when it finds it necessary to ensure the benefits of a drug outweigh the risks of the drug. The FDA then implemented a more rigorous form of the restrictions known as “Elements to Assure Safe Use,” which the agency may only impose because of a drug’s “inherent toxicity or potential harmfulness.”
“By statute, FDA may impose ETASU only for medications that demonstrate risks of serious side effects such as death, incapacity, or birth defects, and only where the risk of side effects is sufficiently severe that FDA could not approve, or would have to withdraw approval of, the medication, absent the ETASU,” Ferguson says in the complaint, adding the restriction cannot place unduly burdensome access to patients in rural or underserved areas and must minimize the burden on the health care delivery system.
According to Ferguson, cases of FDA statutory limitations are exceptionally rare. “Of the more than 20,000 prescription drug products approved by FDA and marketed in the U.S., there are only 60 REMS in place, 56 of which include an ETASU, covering dangerous drugs like fentanyl and other opioids.”
Used together, the attorney general says the regulations limit who can prescribe and dispense the drug. For example, now medical providers must also be certified to prescribe mifepristone, in which they can attest that that they can accurately date a pregnancy, diagnose an ectopic pregnancy and provide a surgical intervention or a referral in the event of a complication. From there, the certification must be submitted to a certified pharmacy that a provider intends to use in addition to the distributor if a provider intends to dispense medications in-office.
Moreover, Ferguson outlines how the regulation’s requirements of patients make telehealth less accessible and creates dangerous paper trails amid criminalization and outlawing of abortion in states like Idaho and Texas. For instance, the FDA’s regulation now requires patients to sign an agreement form to receive a mifepristone prescription that certifies: “I have decided to take mifepristone and misoprostol to end my pregnancy.”
“This patient agreement form must be signed by both the patient and provider, a copy must be placed into the patient’s medical record, and a copy must be given to the patient along with the medication guide,” Ferguson says, noting the form creates a significant privacy and safety issue for all parties involved — particularly for women taking the medication for miscarriage management and for those from states where abortion is criminalized.
An FDA spokesperson declined to comment on pending litigation.
Ten other states join Washington state and Oregon in the lawsuit, many of which also joined Ferguson and Rosenblum on Tuesday in launching a a nonpartisan coalition committed to protecting and expanding reproductive rights throughout the U.S.
“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 Rosenblum in a statement. "Our coalition stands by our belief that abortion is health care, and health care is a human right."
In the meantime, Ferguson also requested a preliminary injunction against the Biden administration on Friday asking the Eastern District of Washington to halt the FDA’s requirements while the lawsuit continues.
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