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US court preserves access to abortion drug mifepristone for now US court preserves access to abortion drug mifepristone for now
(about 4 hours later)
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 temporarily blocked a decision by a Texas judge to halt the government's approval of a widely used abortion drug. A US appeals court has ruled that a widely used abortion pill could remain available, but imposed new restrictions that may impede access nationwide.
Mifepristone - one of two drugs used for medication abortions - was approved by the Food and Drug Administration and has been allowed for over 20 years. The court's decision temporarily blocks an order by a Texas judge to halt federal approval of mifepristone.
Abortion pills are now the most common method of ending a pregnancy, used in more than half of all US abortions. The drug - one of two used for medication abortions - will remain available until the appellate court hears the Texas case on its merits.
This ruling means access to it will be maintained but with some restrictions. But under the new ruling, the pill can no longer be sent to patients by mail.
They include a requirement to visit one's doctor to get the drug and limiting its use to the first seven weeks of pregnancy from the current 10. The appellate court also shortened the window for mifepristone's approved use from up to 10 weeks of pregnancy down to seven.
Critics of the ruling by Texas Judge Matthew Kacsmaryk say it will open the door for challenges to other approved medicines in the US and could also stifle development of future drugs. The new restrictions will likely be felt across the country.
In his 8 April ruling, Judge 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. 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.
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 judge's decision. 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.
The ruling by the Texas judge - who was appointed by former President Donald Trump - came after the Supreme Court removed constitutional protections for abortion last year, triggering a wave of state-by-state bans. 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.
The ruling came after the Supreme Court removed constitutional protections for abortion last year, triggering a wave of state-by-state bans.
How safe is the abortion pill mifepristone?How safe is the abortion pill mifepristone?
How abortion pill ruling threatens other drugs How abortion pill ruling threatens other drugs 
Experts have told the BBC the abortion pill case will probably ultimately be heard by the Supreme Court. 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.
Mifepristone is part of a two-drug regimen that induces abortions - it effectively stops the pregnancy, while the second drug, misoprostol, empties the uterus. "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.
It was first approved for the termination of pregnancy up until seven weeks' gestation. 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.
In 2016, its approved use was extended to 10 weeks of pregnancy. 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.
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.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.
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.
The Americans turning to Mexico to get abortionsThe Americans turning to Mexico to get abortions
Some 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. 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.
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.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.
This week, more than 300 pharmaceutical executives called for the Texas decision to be reversed, arguing it disregarded scientific evidence.This week, more than 300 pharmaceutical executives called for the Texas decision to be reversed, arguing it disregarded scientific evidence.
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