Washington FDA lawsuit is part of larger strategy to preserve abortion access
Apr 18, 2023 | 2:15 pm ET
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As the nation grapples with continuing changes in court rulings affecting the U.S. Food and Drug Administration’s approval of a drug used in abortion care, Washington state’s competing lawsuit and other offensive and defensive moves related to abortion are working exactly as officials and advocates say they intended.
Washington Attorney General Bob Ferguson’s office filed a lawsuit against the FDA in late February, about a month after the federal agency announced it would keep mifepristone, a drug used in tandem with another to end a pregnancy of up to 10 weeks’ gestation, under restrictions associated with its Risk Evaluation and Mitigation Strategies program — also known as REMS.
The FDA requires health care providers who prescribe mifepristone to be certified in its REMS program and mandates the drug be dispensed by or under the supervision of certified prescribers or pharmacies. Providers must also inform patients about “the risk of serious complications associated with mifepristone.” As part of the announcement earlier this year, the FDA also said it would loosen its dispensing requirements, allowing pharmacies to prescribe it directly.
The FDA has said its certification process for physicians ensures the provider has the ability to accurately date a pregnancy, diagnose ectopic pregnancies and provide or arrange for surgical intervention if necessary.
In the complaint, Ferguson’s office argued the FDA’s restrictions on mifepristone are unreasonable given its safety and effectiveness record over the past 23 years, and that the restrictions create undue administrative and financial burdens on providers and make it more difficult for patients to access the medication via telehealth.
While U.S. District Judge Thomas Rice, who was appointed by President Barack Obama, has not yet ruled whether those restrictions should be lifted, he did issue an injunction preserving the FDA’s requirements as they are in the 17 states and Washington, D.C., until the case is resolved.
What other drugs have REMS?
As of April 2023, REMS requirements are in place for 63 of the more than 20,000 drugs approved by the FDA for marketing in the U.S. The REMS are assigned to certain drugs to ensure that the benefits of the drug or biological product outweigh the risks, according to the FDA.
Some of the 63 drugs are highly potent medications used to treat various forms of cancer. Some are for severe psychiatric disorders that can cause respiratory issues, and some are opioids with high risks of addiction and dependence. One is meant to slow the progression of kidney disease but can cause serious and potentially fatal liver injuries. Others have risks of severe or fatal birth defects.
Mifepristone blocks production of a hormone called progesterone, which is vital to the continuation of a pregnancy. The FDA has recorded 28 deaths following the use of the drug out of 5.6 million uses and has stated mifepristone cannot be identified as a cause of those deaths.
Nine of the deaths were caused by septic infections, and a majority of the remaining deaths involved homicide, drug overdoses, ruptured ectopic pregnancies and suicide.
Advocates often point out that mifepristone is safer than Tylenol and Viagra, the latter of which was associated with 522 deaths after its first 13 months on the market in 1998, according to FDA data.
Molly Meegan, chief legal officer and general counsel for the American College of Obstetricians and Gynecologists, said REMS are generally used when there is a danger to the patient or when the administration of a drug needs to be controlled.
“These requirements dated back to a time in which there was concern about mifepristone and what would happen when people were able to experience a medication abortion at home,” Meegan said. “Time has proven that there really is no danger, that it’s very safe and very effective. … The Washington case was a very interesting use of the federal courts to try to make sure that a safe, effective drug was available in the states that wanted it to be. It was creative and pretty smart.”
What other drugs have REMS?
As of April 2023, REMS requirements are in place for 63 of the more than 20,000 drugs approved by the FDA for marketing in the U.S. The REMS are assigned to certain drugs to ensure that the benefits of the drug or biological product outweigh the risks, according to the FDA.
Some of the 63 drugs are highly potent medications used to treat various forms of cancer. Some are for severe psychiatric disorders that can cause respiratory issues, and some are opioids with high risks of addiction and dependence. One is meant to slow the progression of kidney disease but can cause serious and potentially fatal liver injuries. Others have risks of severe or fatal birth defects.
Mifepristone blocks production of a hormone called progesterone, which is vital to the continuation of a pregnancy. The FDA has recorded 28 deaths following the use of the drug out of 5.6 million uses and has stated mifepristone cannot be identified as a cause of those deaths.
Nine of the deaths were caused by septic infections, and a majority of the remaining deaths involved homicide, drug overdoses, ruptured ectopic pregnancies and suicide.
Advocates often point out that mifepristone is safer than Tylenol and Viagra, the latter of which was associated with 522 deaths after its first 13 months on the market in 1998, according to FDA data.
Molly Meegan, chief legal officer and general counsel for the American College of Obstetricians and Gynecologists, said REMS are generally used when there is a danger to the patient or when the administration of a drug needs to be controlled.
“These requirements dated back to a time in which there was concern about mifepristone and what would happen when people were able to experience a medication abortion at home,” Meegan said. “Time has proven that there really is no danger, that it’s very safe and very effective. … The Washington case was a very interesting use of the federal courts to try to make sure that a safe, effective drug was available in the states that wanted it to be. It was creative and pretty smart.”
Washington judge reaffirmed court ruling’s effectiveness
Although Ferguson’s office sought a nationwide order, Rice limited his ruling to the plaintiffs who signed on to the lawsuit, which includes Washington and 16 other states and Washington, D.C.
“Based on the public health and administrative considerations at issue in this case, plaintiffs have shown the balance of the equities sharply tip in their favor and the public interest favors a preliminary injunction,” Rice wrote in his decision.
Rice’s ruling was issued April 7, within an hour after U.S. District Judge Matthew Kacsmaryk released his contradictory ruling in Texas ordering the FDA to pause its entire approval of mifepristone while that case proceeds.
Kacsmaryk’s ruling was scheduled to take effect nationwide on Friday, but following a decision from the Fifth Circuit Court of Appeals on Wednesday, the FDA’s approval will remain in effect with more restrictions that had been lifted since 2016. Under the new order, the medication will be for up to seven weeks of pregnancy instead of 10, and telehealth or mailed prescriptions will not be permitted.
The gestational limits could be avoided by prescribing the drug “off label,” meaning in a manner that is outside of its approved use, according to University of Pittsburgh School of Law Professor Greer Donley. Donley told States Newsroom it would be no different than a provider using mifepristone to manage a miscarriage, which doctors commonly do.
Attorneys for the U.S. Department of Health and Human Services asked Judge Rice to clarify his order given the confusion over the Texas ruling this week, and Rice wrote that nothing has changed for the plaintiff states in his case.
“Because the court has jurisdiction over the parties before it and limited its preliminary injunction only to the plaintiff states and the District of Columbia, this court’s preliminary injunction was effective as of April 7, 2023, and must be followed by defendants,” Rice wrote.
Washington stockpiled mifepristone before Texas ruling
The lawsuit is one of several steps Washington has taken just in the past six months to preserve and protect abortion access for its residents and those who travel to the state for care. Washington shares a border with Idaho, where abortion is illegal at any stage of pregnancy and medical providers are subject to felony charges for providing abortion services. Providers in Washington have reported increasing numbers of patients from Idaho seeking abortions in their state, as abortions are legal in Washington up to the point of fetal viability, as determined by a health care provider.
In anticipation of the Texas court ruling, Gov. Jay Inslee ordered the purchase of 30,000 doses of mifepristone for nearly $1.3 million, paid out of the state’s family planning funding budget within the Washington State Department of Health, according to Inslee’s spokesperson Jaime Smith. The medication will be stored and dispensed by the Washington State Department of Corrections, Smith said, because it was the state agency with the most appropriate type of pharmacy license. The doses should be enough to last about three years, Inslee said in an announcement.
“Regardless of what happens in this litigation regarding the Texas court decision, mifepristone will remain available in the state of Washington,” Inslee said at a press conference Thursday. “We had the foresight to acquire it before this judge’s outrageous decision.”
Shield law to defend against states like Idaho, Texas
Other pieces of legislation addressing abortion access are still awaiting Inslee’s signature, but he is expected to sign them soon, including a shield law that Planned Parenthood Great Northwest urged Washington legislators to pass.
Courtney Normand, Washington state director of Planned Parenthood Alliance Advocates, said the shield law prohibits the issuance of out-of-state subpoenas seeking information related to abortion in the state of Washington. It also prohibits out-of-state arrest warrants and any information sought about an individual’s abortion. Normand said it prevents the governor from extraditing any individuals for out-of-state charges and protects people from civil causes of action related to providing or aiding someone seeking an abortion. The shield law also applies to those seeking gender-affirming care.
Normand said advocates like Planned Parenthood expected other states to begin passing laws that would attempt to limit access to abortion in states like Washington. She cited a law passed by the Idaho Legislature in March, House Bill 242, that prohibits adults from transporting minors from Idaho to a state where abortion is legal without parental permission, along with short-lived legal advice from Idaho Attorney General Raúl Labrador that stated referrals from medical providers for abortions in states where it is legal would violate Idaho law. Labrador rescinded that letter after Planned Parenthood filed a lawsuit against his office.
“The level of aggression and extreme interpretation coming out of Idaho is alarming. We continue to see increasing numbers of patients from Idaho and it’s really important that they understand they’ll be safe coming here,” Normand said.
Idaho anti-abortion leader: States coming into conflict post-Dobbs
She also cited a recent story out of Texas about a man filing a lawsuit against three women because he says they helped his ex-wife obtain abortion medication to end her pregnancy.
“Let’s say the woman who got the abortion came to Washington for that. If there was some kind of inquiry asking Washington law enforcement to provide information about her traveling here or asking for her to be extradited, that’s the kind of thing that this law would block,” Normand said.
The law does not apply to cases of malpractice, Normand said — only instances where the care provided was legal and proper.
David Ripley, founder of Idaho Chooses Life, said he was happy to see House Bill 242 pass this session and called it a righteous policy that he thinks will be upheld by the courts if it is challenged.
“There’s no question in my mind that the state of Idaho has the right to do what it did and it is a righteous policy, and I have no doubt it will be upheld in various courtrooms with respect to Idaho residents and the jurisdiction it has over its citizens,” Ripley said.
He compared the vast differences in abortion laws between neighboring states to the Civil War era’s differing laws on slavery.
“We’re in a very fascinating and odd time with respect to American history,” Ripley said. “The fact that you have states committed to defending preborn children and other states equally committed to defending the right to an abortion — those states are coming into conflict, there’s no doubt about that,” he said.
Advocates push for data privacy law, more funding for abortion care
There are a few more steps advocates in Washington would like to see implemented soon to further enshrine access. Kia Guarino, executive director of Pro-Choice Washington, said her organization works closely with Attorney General Ferguson’s office and helped put together bills for the 2023 legislative session related to abortion access, including the shield law and a data privacy bill called the My Health, My Data Act. That legislation would protect personal health information collected on digital platforms from disclosure, including data from period-tracking apps and other websites. The bill has passed and will soon await Gov. Inslee’s signature.
Another bill that made it through the legislative process will end cost sharing for abortion care and require insurance companies in Washington to cover the entire cost of abortion procedures and services.
“The co-pays can be so prohibitive, and it was a big barrier,” Guarino said.
Moving forward, advocates say they want to see more funding for abortion providers and access funds and say that there’s always more to be done.
Julia Marks, litigation attorney at Washington-based organization Legal Voice, said one of the most important aspects will be continuing to educate people about current laws and policies amid flurries of news stories and confusion about what’s coming next.
“The headlines are scary, and they should be, because these are big cases and unprecedented decisions that have widespread effects, but it is a confusing landscape and there are many people who can still access care, especially as these court cases continue forward,” Marks said.
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