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The Biden administration argued in a court filing to the Supreme Court on Tuesday that decades of studying the abortion pill support the changes that the Food and Drug Administration made to make it easily available for patients.
U.S. Solicitor General Elizabeth Prelogar said in her filing that the FDA’s “changes to mifepristone’s approved conditions of use were supported by an exhaustive review of a record including dozens of scientific studies and decades of safe use of mifepristone by millions of women in the United States and around the world.”
She added, “Congress has entrusted FDA with the authority and responsibility to determine whether a ’new drug’ is safe and effective before it is distributed.”
The legal battle is pending before the high court after the feds asked the justices to review a lower court ruling that found FDA changes to the abortion pill, specifically mifepristone, were unlawful.
The justices will consider how long the pill can be prescribed during pregnancy and if it can be mailed as federal officials proposed in recent administrative changes.
In 2016, the FDA moved to allow the pill to be used from seven to 10 weeks gestation, require fewer in-person doctor visits and let nondoctors prescribe the drug. In 2020, due to the COVID-19 pandemic, the feds suggested letting the abortion pill be mailed to patients rather than be picked up in person.
The high court last year overturned Roe v. Wade, the landmark 1973 case that established a national right to abortion, returning jurisdiction on the procedure to the states. Since then, 14 states have moved to ban the procedure other than for an exception to save the life of the mother. A handful of states have moved to ban it after six to 15 weeks of pregnancy.
It took at least four justices to vote in favor of hearing the abortion pill dispute. Oral arguments are likely to occur in the spring, with a decision to come by the end of June.
The pill has remained available during the appellate process after the Supreme Court placed the lower court ruling on hold. But the 5th U.S. Circuit Court of Appeals restricted the use of the pill, saying it couldn’t be distributed via mail and could be used only before seven weeks of pregnancy.
A district court had gone further, ruling that the drug shouldn’t have been authorized by the Food and Drug Administration.
Danco Laboratories, a producer of mifepristone, petitioned the high court over its production of the pill, challenging the lower court’s restrictions on its distribution.
Mifepristone, approved by the FDA during the Clinton administration, is used with misoprostol to terminate a pregnancy.
The abortion pill accounts for more than half of abortions in the U.S. Over 5 million people have used it since 2000, according to The Associated Press.
The battle over the drug enraged supporters of abortion after U.S. District Judge Matthew Kacsmaryk, a Trump appointee, last year ruled the FDA’s approval of mifepristone was unlawful.
He said the FDA couldn’t continue to approve the pill in a case brought by pro-life advocates and physicians who argued that women have had grave health consequences from using the pill.
The 5th Circuit disagreed and didn’t uphold Judge Kacsmaryk’s ruling that the pill was unlawfully authorized by the FDA.
Instead, the circuit court’s ruling said the drug could still be dispensed but not through the mail as regulators had begun to allow in 2016, and only up to seven weeks into pregnancy.
The drug was approved in 2000, but it was not sent through the mail. Its administration required three steps: first a visit with a doctor to receive mifepristone, then another one to get the drug misoprostol. A third visit was required to address complications.
Alliance Defending Freedom Senior Counsel Erin Hawley, vice president of the Center for Life & Regulatory Practice who has represented pro-life doctors, said women need to have ongoing care from a physician when taking the high-risk drug.
“But the Biden administration is defending the FDA’s reckless removal of the safety standards it originally deemed necessary for women who use abortion drugs. The FDA’s own label for these drugs says that roughly 1 in 25 women who take them will end up in the emergency room. The agency’s removal of in-person doctor visits and consistent, ongoing care has subjected more women to suffering severe, even life-threatening, medical conditions. Regardless of Americans’ beliefs about abortion, no one should be OK with the FDA leaving girls to take these high-risk drugs all alone. We urge the Supreme Court to hold the FDA accountable and require the agency to reinstate its safety standards,” she said.
• Alex Swoyer can be reached at aswoyer@washingtontimes.com.
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