SEATTLE — Washington’s attorney general is leading a 12-state lawsuit against the U.S. Food and Drug Administration, accusing it Friday of unnecessarily complicating access to a common abortion pill.
The lawsuit pushes for fewer restrictions on prescribing and dispensing mifepristone, a drug that was approved by the FDA more than 20 years ago and is considered to be highly safe and effective, according to Attorney General Bob Ferguson’s office. But since the U.S. Supreme Court overturned Americans’ constitutional right to abortion last June, anti-abortion groups have built momentum in their efforts to ban the pill nationwide.
Ferguson filed the complaint Thursday evening in the U.S. District Court for the Eastern District of Washington, joined by Oregon, Nevada, Delaware, Arizona, Illinois, Connecticut, Colorado, Vermont, New Mexico, Michigan and Rhode Island.
“The federal government has known for years that mifepristone is safe and effective,” Ferguson said in a Friday 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.”
Mifepristone is one of two common abortion pills in the United States, usually taken together to end early pregnancies. Mifepristone first blocks the hormone progesterone, causing the lining of the uterus to break down and halt a pregnancy. Then, misoprostol, the second pill, empties the uterus.
The FDA approved the two-pill plan, shown to be effective at least 95% of the time, in 2000, after it had been widely used in Europe for years.
Last year, however, anti-abortion activists filed a federal lawsuit in Texas, arguing mifepristone was improperly approved at the time. According to The Associated Press, they said the FDA used an accelerated approval process meant only for drugs that treat “serious or life-threatening illnesses” — though the FDA said it didn’t actually accelerate the approval.
A decision in that case is expected imminently. If a federal judge overturns FDA approval, sales of the drug could halt in all states, even those such as Washington where abortion remains legal.
On Friday, Kristin Beneski, the state’s first assistant attorney general, called the Texas lawsuit “meritless.”
“We think the FDA was absolutely right when it followed the science and data,” she said. “It’s made that conclusion again repeatedly over the years.”
Earlier this month, Ferguson’s office joined more than 20 attorneys general in filing an amicus curiae, or “friend of the court,” brief in the Texas case, advocating for the drug’s safety and efficacy.
Meanwhile, Beneski and her colleagues are hoping to remove federal restrictions, also known as Risk Evaluation & Mitigation Strategies, from prescribing and getting mifepristone. The restrictions, which the FDA says are supposed to apply to drugs with “serious safety concerns,” have complicated access to mifepristone for years, Beneski said.
But now, there’s a “crisis of abortion access in our country,” she said. “Our health care system has never been besieged like this.”
According to the FDA, health care providers must be specially certified by the drug distributor in advance to prescribe mifepristone. Then, to receive the prescription, patients and providers must sign an agreement that certifies the patient has decided to take drugs to end their pregnancy — regardless of whether they’re seeking an abortion or are being treated for a miscarriage. The agreement is required to be included in the patient’s medical record, which can sometimes dissuade them from going through with the abortion, Beneski said.
Pharmacies are also then required to have a special certification before they can fill a mifepristone prescription.
The lawsuit asks the court to find the FDA’s restrictions unlawful and to bar the agency from enforcing or applying them to mifepristone. It also seeks to ensure that mifepristone remains accessible, Beneski said.
“Just to contextualize this, the statute that regulates the FDA says you can only have restrictions like this on a small subset of dangerous drugs,” Beneski said. “Opioids and fentanyl have these kinds of restrictions — and other drugs that have a much less safe record than mifepristone does.”
She continued, “You don’t need to sign this for the vast majority of drugs.”
About 60 other drugs, out of the more than 20,000 approved by the FDA, fall under the Risk Evaluation & Mitigation Strategies, according to a statement from Ferguson’s office.
In 2021, nearly 60% of Washington state’s 15,000-plus abortions were medication abortions that followed the two-pill regimen, Ferguson’s office said. Less than 0.1% led to a complication that required hospitalization. No deaths connected to mifepristone have been reported.
While the majority of medication abortions use both mifepristone and misoprostol, the second has been safely used alone for decades in other parts of the world, doctors have said. The World Health Organization has also agreed misoprostol can be used on its own.
But if mifepristone is banned in the U.S., health care providers and patients would have fewer options in pregnancy care, NPR reported.
“These 12 states that are filing this lawsuit represent 60 million Americans that have protected abortion rights,” Beneski said. “That’s what we’re fighting for — meaningful access to care.”
Information from The Associated Press and NPR was included in this article.
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