The FDA approved mifepristone under the brand-name Mifeprex in 2000, and an abortion-drug regimen that has seen few deaths of pregnant patients and a low rate of adverse events in more than two decades of use. (Photo by Peter Dazeley/Getty Images)
WASHINGTON — Attorneys general from 21 Democratic-leaning states are calling on a Texas judge to keep the abortion pill on the market, rejecting claims anti-abortion medical groups made in a lawsuit that’s centered on the medication’s approval more than two decades ago.
The latest brief in the case, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, will likely bring even more attention to a lawsuit that could have sweeping, nationwide effects for medication abortion.
The two-medication regimen, consisting of mifepristone and misoprostol, is approved for up to 10 weeks into a pregnancy and accounts for more than half of abortions in the United States.
New York Attorney General Letitia James filed the brief on behalf of her state as well as California, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, North Carolina, Oregon, Pennsylvania, Rhode Island, Washington, Wisconsin and the District of Columbia.
22 years of use
The attorneys general argue in their brief that medication abortion is safe and effective, as proven by 22 years of approved use.
They wrote that requiring the U.S. Food and Drug Administration to remove mifepristone would force patients to undergo a procedural abortion or to “forgo an abortion entirely,” both of which “would have devastating consequences” for residents of their states.
“Procedural abortion is not only more invasive than medication abortion, but it is also generally more costly and difficult to obtain,” the attorneys general wrote. “Indeed, the availability of mifepristone has been particularly critical in providing access to abortion in low-income, underserved, and rural communities where procedural abortion may be unavailable.”
“And because medication abortion is the most common method used to terminate pregnancy during the first trimester, eliminating access to this method will result in more abortions taking place later in pregnancy, further increasing costs and medical risks,” they added.
The lawsuit, filed in mid-November by anti-abortion legal organization Alliance Defending Freedom, on behalf of four anti-abortion medical organizations and four anti-abortion physicians, argues the FDA overstepped its authority in 2000 when it approved mifepristone to end pregnancies.
The lawsuit calls on the Trump-appointed U.S. district court judge to pull the abortion pill from the market entirely, or to at least set the dispensing and dosage requirements back to how they were authorized before the FDA made changes in 2016 and during the pandemic.
The brief filed by the Democratic attorneys general is substantially different from the brief 23 Republican attorneys general, including Iowa’s, filed last week.
The Democratic attorneys general disparaged the claims made in the lawsuit, including that medication abortion is not safe or effective.
They pointed to a comprehensive survey by the National Academies of Sciences, Engineering, and Medicine that “concluded that medication abortion — like procedural abortion — is safe and effective and that complications after medication abortion are rare, i.e., ‘occurring in no more than a fraction of a percent of patients.’”
“The relatively few adverse events associated with medication abortion are well within an acceptable range for FDA approval,” the attorneys general wrote. “Indeed, evidence shows that medication abortion is as safe or safer than numerous other types of FDA approved drugs and products, including Viagra (four times safer), penicillin (two times safer), and even acetaminophen.”
The attorneys general also wrote that it would be impossible to cover up the number and type of complications the anti-abortion groups claim mifepristone causes in medication abortions.
“Given the widespread use of mifepristone, if plaintiffs’ allegations regarding the magnitude of risk associated with medication abortion were accurate, those harmful effects would be impossible to hide at the population level,” the attorneys general wrote. “But amici have seen no such effects — and in fact, the opposite is true.”
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