12 States Sue F.D.A., Seeking Removal of Special Restrictions on Abortion Pill
The attorneys general of a dozen Democratic-controlled states sued the Food and Drug Administration on Friday, asking a judge to remove special restrictions that the federal agency has long applied to the first of two drugs used in medication abortion.
The suit, filed in a Federal District Court in Washington State, comes at a tense moment in the battle over the legal status of abortion pills, which are used in more than half of abortions in the United States. A federal judge in Texas is expected to issue an order soon in a case filed by anti-abortion groups that seeks to overturn the F.D.A.’s approval of the same abortion pill, mifepristone, and have it taken off the market.
The potential consequences of the Texas case have set the reproductive health community on edge out of concern that the judge, a Trump appointee who is politically conservative and wrote an article that was critical of Roe v. Wade, could issue an order effectively blocking access to mifepristone across the country. Such a ruling would immediately be appealed, but if it ultimately stands, it would have far-reaching implications, affecting states where abortion is legal, not just states where abortion is already restricted.
The new lawsuit filed by the 12 states does not address the possible outcomes of the Texas case, but it requests that the judge’s ruling in the Washington case include orders that would effectively contravene steps that might be imposed by the Texas judge. While the Washington case primarily asks the court to order the F.D.A. to eliminate a framework of extra restrictions applied to mifepristone, the suit also asks the judge to declare that the F.D.A.’s “approval of mifepristone is lawful and valid” and to enjoin the F.D.A. “from taking any action to remove mifepristone from the market or reduce its availability.”
Ameet Sarpatwari, a lawyer and assistant professor of medicine at Harvard Medical School, said the timing and content of the lawsuit were strategic.
“It is a legally and politically savvy move to file this complaint now,” he said. “If you have a federal judge in one jurisdiction saying the approval was lawful, and actually enjoining F.D.A. from taking action to restrict access, that would stand in exact conflict with what many presume the Texas judge may do, which is actually rescind the approval of the drug.”
If two federal rulings were to conflict, said Dr. Sarpatwari, an expert on F.D.A. regulations, “that gives ground for the federal government to say, ‘Look, I’ve got two courts saying two fundamentally different things, and the best we can do right now is to not do anything.” That could result in both cases landing before the Supreme Court and in preserved access to mifepristone until a high court decision, he said.
Kristin Beneski, first assistant attorney general for Washington State, said the goal of the new lawsuit “is to protect and expand access to medication abortion.”
She added, “It’s not right for one judge in Texas to decide for all Americans whether they can access the gold standard of care for early pregnancy termination.”
The F.D.A. declined to comment on the new case, saying it does not discuss pending litigation.
In the Texas lawsuit, anti-abortion groups claim that the F.D.A. improperly approved mifepristone and ignored safety risks. In a filing in that case, the F.D.A. disputed those claims and said that revoking its drug approval would “cause significant harm, depriving patients of a safe and effective drug that has been on the market for more than two decades.”
The filing on Friday was led by the attorneys general of Washington and Oregon, who were joined by their counterparts in Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont. The suit takes aim at a special framework of restrictions and monitoring that the F.D.A. currently applies to only about 60 drugs. Called a Risk Evaluation and Mitigation Strategy, or REMS, it has applied to mifepristone for about a dozen years.
Initially, it was considerably more restrictive than it is now, with rules requiring that patients obtain mifepristone in person from a health care provider, although they could take the drug on their own at home or anywhere they chose.
In recent years, the F.D.A. has extensively reviewed new data on mifepristone and lifted several of the restrictions, including the in-person requirement. It now allows the drug to be sent to patients by mail and recently authorized retail pharmacies to dispense the medication if they become specially certified.
The agency’s remaining special requirements for mifepristone are that patients sign an agreement attesting that they have chosen to take the medication to terminate a pregnancy. Providers and pharmacies must become certified, which is not difficult but involves certain administrative and logistical steps.
Ms. Beneski said the certification requirements and the agreement that patients must sign are burdensome, project an erroneous sense that the medication is unsafe and have deterred many providers who would otherwise prescribe mifepristone, limiting access to medication abortion. The requirements, which generate lists of certified providers, also make providers worry about their privacy in a political environment where, she said, “they are really concerned about being targets of violence and harassment.”
“We are not arguing that the F.D.A. should not have approval authority over mifepristone, only that the REMS system is unnecessary for this drug and poses unnecessary risks to providers and patient in the current legal landscape,” Ms. Beneski said. “Those risks are real, and need to be addressed.”
Mifepristone is also used for treatment of miscarriage, and the F.D.A. restrictions also apply for those patients, who must attest when signing the agreement that they have “decided” to end their pregnancy, the lawsuit says.
While abortion opponents assert that medication abortion has serious safety risks, mainstream medical organizations and abortion rights groups have long said that special restrictions on mifepristone are unnecessary, citing years of data on safety and efficacy. But, in an unusual twist, since the Supreme Court decision overturning Roe v. Wade, some reproductive health legal experts have argued that officially keeping the REMS framework in place is beneficial in fighting against state laws that aim to ban or restrict abortion.
Their argument is that the F.D.A.’s decision to apply special restrictions to mifepristone, and to gradually ease some of them as evidence of safety and efficacy has grown, shows how careful and rigorous the federal government has been with the drug and strengthens the case that the F.D.A. has ultimate authority over states. That argument was made recently in two lawsuits that challenge the constitutionality of state abortion bans and restrictions — one filed in West Virginia by a mifepristone manufacturer and the other in North Carolina by an obstetrician-gynecologist.
On Friday, though, several of those experts said they supported the new lawsuit’s effort to lift the extra restrictions. David S. Cohen, a law professor at Drexel University, said that while lawsuits claiming that F.D.A. regulations pre-empt state laws “are ironically helped by these restrictions,” the cases do not need those restrictions to succeed.
Dr. Cohen called the new lawsuit a “great strategy,” adding that “removing the needless restrictions the F.D.A. has imposed on the drug — restrictions not backed by any science — is one of the highest priorities.”
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