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US court preserves access to abortion drug mifepristone for now US will take Texas abortion pill case to Supreme Court
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Watch: Abortion pills explained in 60 secondsWatch: Abortion pills explained in 60 seconds
Watch: Abortion pills explained in 60 secondsWatch: Abortion pills explained in 60 seconds
A US appeals court has ruled that a widely used abortion pill could remain available, but imposed new restrictions that may impede access nationwide. The Biden administration will ask the Supreme Court to restore full access to an abortion drug after a lower court imposed restrictions on its use.
The court's decision temporarily blocks an order by a Texas judge to halt federal approval of mifepristone. On Wednesday, an appellate court blocked a Texas judge's ruling to halt approval of mifepristone, meaning the pill would remain available.
The drug - one of two used for medication abortions - will remain available until the appellate court hears the Texas case on its merits. But it invoked significant limits on its use, including barring patients from receiving it by mail.
But under the new ruling, the pill can no longer be sent to patients by mail. Mifepristone is used in more than half of all US abortions.
The appellate court also shortened the window for mifepristone's approved use from up to 10 weeks of pregnancy down to seven. "We will be seeking emergency relief from the Supreme Court to defend the FDA's [Food and Drug Administration's] scientific judgment and protect Americans' access to safe and effective reproductive care," US Attorney General Merrick Garland said in a statement on Thursday.
The new restrictions will likely be felt across the country. For now the drug - one of two used for medication abortions - will remain available until the appellate court hears the Texas case on its merits, but under new conditions.
Mifepristone was first approved by the US Food and Drug Administration (FDA) more than 20 years ago and abortion pills are now the most common method of ending a pregnancy - used in more than half of all US abortions. In addition to stopping the drug's provision by mail, the appellate court also shortened the window for mifepristone's approved use, from up to 10 weeks of pregnancy to seven.
Last week, on 8 April, Texas Judge Matthew Kacsmaryk ordered pulling mifepristone from the market in seven days' time, saying the FDA had violated federal rules that allowed for the accelerated approval of some drugs. The order was set to take effect on Friday. In this latest move, the justice department has asked the country's top court to strike down these limitations, which were set to take effect on Saturday.
The Department of Justice and the drug manufacturer applied for an emergency stay on the ruling on Monday, asking the court to put a hold on the Trump-appointee's decision. Mifepristone was first approved by the US Food and Drug Administration (FDA) more than 20 years ago. The drug is part of a two-drug regimen that induces abortions - it effectively stops the pregnancy, while the second drug, misoprostol, empties the uterus.
The ruling came after the Supreme Court removed constitutional protections for abortion last year, triggering a wave of state-by-state bans. But last week, on 8 April, Texas Judge Matthew Kacsmaryk ordered pulling mifepristone from the market, saying the FDA had violated federal rules that allowed for the accelerated approval of some drugs.
The Department of Justice and the drug manufacturer applied for an emergency stay on the Texas court's ruling.
And late on Wednesday night, the Fifth US Circuit Court of appeals agreed, saying the FDA's decades-old approval of mifepristone should stand, because too much time had passed to challenge that decision. But the appellate panel decided to roll back several changes made by the FDA starting in 2016 that eased access to the drug.
Experts say the legal fight will have far-reaching implications for both abortion access and drug regulation in the United States.
How safe is the abortion pill mifepristone?How safe is the abortion pill mifepristone?
How abortion pill ruling threatens other drugs  Abortion pills a new front in culture wars
The closely-watched case is expected to reach the Supreme Court. And it is so far unclear how a duelling ruling out of Washington, which ordered the FDA to keep mifepristone on the market in 17 Democratic-run states, may effect this recent development. "We are in unprecedented territory," Areta Kupchyk, a former FDA associate chief counsel, told the BBC, saying she could not recall a single other example of the FDA being forced to withdraw approval for a drug long considered safe for use.
"We are in unprecedented territory," Areta Kupchyk, a former FDA associate chief counsel, told the BBC, saying she could not recall a single other example of the FDA being forced to withdraw approval long considered safe for use. Anti-abortion campaigners who have opposed mifepristone's FDA approval claimed the agency made a politically motivated decision in approving the drug, and said it did not follow proper protocols.
Kristi Hamrick, spokeswoman for the anti-abortion organisation Students for Life of America, applauded the Texas ruling, calling it an "evidence-based rejection" of poor safety standards used to regulate abortion pills.
The FDA spent four years reviewing mifepristone before it was approved in 2000, and placed the drug in a select category of just 60 drugs that is regulated under a system of extra restrictions, which are repeatedly re-evaluated.The FDA spent four years reviewing mifepristone before it was approved in 2000, and placed the drug in a select category of just 60 drugs that is regulated under a system of extra restrictions, which are repeatedly re-evaluated.
Its safety and effectiveness are supported by mainstream medical organisations including the American College of Obstetrics and Gynaecologists (ACOG) and the World Health Organisation (WHO).Its safety and effectiveness are supported by mainstream medical organisations including the American College of Obstetrics and Gynaecologists (ACOG) and the World Health Organisation (WHO).
The drug is part of a two-drug regimen that induces abortions - it effectively stops the pregnancy, while the second drug, misoprostol, empties the uterus. "It is deeply concerning that appellate judges think they can micromanage FDA decisions for mifepristone and other FDA approved drugs," said Lawrence Gostin, a lawyer and professor of global health law at Georgetown University. "These are scientific decisions that should not be made by lay judges."
Anti-abortion campaigners who have opposed mifepristone's FDA approval alleged the agency made a politically motivated decision in approving the drug, and said it did not follow proper protocols. Mr Gostin told the BBC he hoped the Supreme Court would rule in favour of the FDA but that "all bets were off" with the current bench, where conservative justices hold a 6-3 supermajority.
Kristi Hamrick, spokeswoman for the anti-abortion organisation Students for Life of America, applauded the Texas ruling on Thursday, saying in an email that it was an "evidence-based rejection" of poor safety standards used to regulate abortion pills. And it is so far unclear how a duelling ruling out of Washington, which ordered the FDA to keep mifepristone on the market in 17 Democratic-run states, may effect this recent development.
The Americans turning to Mexico to get abortions Mr Gostin said the Fifth Circuit should only have control on the states in its jurisdiction - Alabama, Florida, Georgia, Texas, Louisiana and Mississippi - meaning the new rules would only apply in those six states.
Several legal analysts, meanwhile, have called the Texas ruling deeply flawed, arguing it cherry-picks evidence and is replete with partisan terminology, including references to "unborn humans" in place of the word foetus. On Thursday, Vice-President Kamala Harris also weighed in on the court battle, saying in a statement that efforts to undermine FDA approval "threatens the rights of Americans across the country".
The Food, Drug and Cosmetic Act of 1938 gives the FDA the authority to determine whether drugs are safe and effective, and typically, courts have deferred to the agency when it comes to scientific and medical decision-making, legal experts say. "Our administration will continue fighting to protect women's health and the right to make decisions about one's own body," said Vice-President Harris.
This week, more than 300 pharmaceutical executives called for the Texas decision to be reversed, arguing it disregarded scientific evidence.
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