(Trends Wide) — A federal judge has said he will suspend the Food and Drug Administration’s two-decade-old authorization of an abortion pill, but paused his decision for seven days so the federal government can appeal.
Trends Wide is reviewing the judge’s 67-page ruling now.
Medical abortion now makes up the majority of abortions obtained in the United States. It has become a key focus after the annulment of the Roe v. Wade.
The lawsuit against the FDA, brought by doctors and anti-abortion medical associations, sought a preliminary injunction that would require the agency to withdraw or suspend its approval of the drug mifepristone, the first drug in the medical abortion process.
US District Judge Matthew Kacsmaryk said the FDA “completely failed to address an important aspect of the problem by omitting any evaluation of the drug’s psychological effects or an evaluation of the drug’s long-term medical consequences, referring to mifepristone.
“Given the intense psychological trauma and post-traumatic stress that women often experience from chemical abortion, this failure should not be overlooked or underestimated,” she said.
Boxes of the drug mifepristone sit on a shelf at the West Alabama Women’s Center in Tuscaloosa, Alabama, on March 16, 2022. Walgreens said Thursday, March 2, 2023, that it will not sell mifepristone, an abortion pill, in 20 states. that they had warned of legal consequences if he did so. Credit: Allen G. Breed/AP
Kacsmaryk also criticized the drug for not being tested in girls under the age of 18 in reproductive development. “But that’s not all,” she continued, criticizing how the FDA handled ultrasound to identify ectopic pregnancy.
But in a dramatic turn of events, Washington federal Judge Thomas Owen Rice issued a new ruling Friday night that the FDA must keep medical abortion drugs available in at least 12 liberal states that sued the FDA to manufacture the abortion pills.
“It is not the role of the Tribunal to review the scientific evidence and decide whether the benefits of mifepristone outweigh its risks without REMS and/or ETASU. That is precisely the role of the FDA,” Rice said. But she said that “the record demonstrates potentially inconsistent findings by the FDA regarding the safety profile of mifepristone.”
This demand is independent of the ruling that occurred in Texas minutes before and that will suspend the approval of the drug.
For her part, Vice President Kamala Harris criticized the decision of the federal judge in Texas, calling it a “dangerous” precedent. The vice president’s brief comments are the first comments from the White House, as President Joe Biden has yet to weigh in publicly on the case.
“Overall, I will say that there is no question that the president and I will stand with the women of America and we will do everything we can to ensure that women have the ability to make decisions about their health care, their reproductive health,” Harris said reporters on the runway before boarding Air Force Two.
Abortion pill safer than some common drugs
Data reviewed by Trends Wide shows that mifepristone is even safer than some of the most common, low-risk prescription drugs, including penicillin and Viagra. There were five deaths associated with the use of mifepristone for every 1 million people in the US who used the drug from its approval in 2000 through last summer, according to the FDA. This assumes a mortality rate of 0.0005%.
By comparison, the risk of death from penicillin, an antibiotic commonly used to treat bacterial infections such as pneumonia, is four times that of mifepristone, according to a study of severe allergic reactions. The risk of dying from the use of Viagra, an erectile dysfunction drug, is nearly 10 times higher, according to a study cited in a report filed by the FDA.
“[La mifepristona] it has been used for more than 20 years, by more than five million people with the possibility of becoming pregnant,” said Ushma Upadhyay, an associate professor in the department of Obstetrics, Gynecology and Reproductive Sciences at the University of California, San Francisco. “Their security is well established.”
The lawsuit, brought by a coalition of anti-abortion national medical associations against the FDA, under the “Hippocratic Medicine Alliance” and several physicians, seeks a series of court actions, primarily an injunction ordering the FDA to “Withdraw mifepristone and misoprostol as FDA-approved drugs for chemical abortion and withdraw defendants’ actions to deregulate these chemical abortion drugs.”
If the lawsuit is successful, an additional 40 million women of reproductive age would lose access to medical abortion services across the country, according to data from abortion rights advocacy group NARAL Pro-Choice America. This number is in addition to the 24.5 million women of reproductive age who live in states that prohibit abortion.
“It goes against decades of scientific and clinical evidence,” says Dana Johnson, a doctoral candidate in public policy and demographics at the University of Texas at Austin, who researches abortion access and health care. “The fact that this lawsuit could undermine something that we know is extremely safe, extremely effective, and is one of the most accessible forms of abortion right now, I think is absolutely terrifying.”
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(Trends Wide) — A federal judge has said he will suspend the Food and Drug Administration’s two-decade-old authorization of an abortion pill, but paused his decision for seven days so the federal government can appeal.
Trends Wide is reviewing the judge’s 67-page ruling now.
Medical abortion now makes up the majority of abortions obtained in the United States. It has become a key focus after the annulment of the Roe v. Wade.
The lawsuit against the FDA, brought by doctors and anti-abortion medical associations, sought a preliminary injunction that would require the agency to withdraw or suspend its approval of the drug mifepristone, the first drug in the medical abortion process.
US District Judge Matthew Kacsmaryk said the FDA “completely failed to address an important aspect of the problem by omitting any evaluation of the drug’s psychological effects or an evaluation of the drug’s long-term medical consequences, referring to mifepristone.
“Given the intense psychological trauma and post-traumatic stress that women often experience from chemical abortion, this failure should not be overlooked or underestimated,” she said.
Boxes of the drug mifepristone sit on a shelf at the West Alabama Women’s Center in Tuscaloosa, Alabama, on March 16, 2022. Walgreens said Thursday, March 2, 2023, that it will not sell mifepristone, an abortion pill, in 20 states. that they had warned of legal consequences if he did so. Credit: Allen G. Breed/AP
Kacsmaryk also criticized the drug for not being tested in girls under the age of 18 in reproductive development. “But that’s not all,” she continued, criticizing how the FDA handled ultrasound to identify ectopic pregnancy.
But in a dramatic turn of events, Washington federal Judge Thomas Owen Rice issued a new ruling Friday night that the FDA must keep medical abortion drugs available in at least 12 liberal states that sued the FDA to manufacture the abortion pills.
“It is not the role of the Tribunal to review the scientific evidence and decide whether the benefits of mifepristone outweigh its risks without REMS and/or ETASU. That is precisely the role of the FDA,” Rice said. But she said that “the record demonstrates potentially inconsistent findings by the FDA regarding the safety profile of mifepristone.”
This demand is independent of the ruling that occurred in Texas minutes before and that will suspend the approval of the drug.
For her part, Vice President Kamala Harris criticized the decision of the federal judge in Texas, calling it a “dangerous” precedent. The vice president’s brief comments are the first comments from the White House, as President Joe Biden has yet to weigh in publicly on the case.
“Overall, I will say that there is no question that the president and I will stand with the women of America and we will do everything we can to ensure that women have the ability to make decisions about their health care, their reproductive health,” Harris said reporters on the runway before boarding Air Force Two.
Abortion pill safer than some common drugs
Data reviewed by Trends Wide shows that mifepristone is even safer than some of the most common, low-risk prescription drugs, including penicillin and Viagra. There were five deaths associated with the use of mifepristone for every 1 million people in the US who used the drug from its approval in 2000 through last summer, according to the FDA. This assumes a mortality rate of 0.0005%.
By comparison, the risk of death from penicillin, an antibiotic commonly used to treat bacterial infections such as pneumonia, is four times that of mifepristone, according to a study of severe allergic reactions. The risk of dying from the use of Viagra, an erectile dysfunction drug, is nearly 10 times higher, according to a study cited in a report filed by the FDA.
“[La mifepristona] it has been used for more than 20 years, by more than five million people with the possibility of becoming pregnant,” said Ushma Upadhyay, an associate professor in the department of Obstetrics, Gynecology and Reproductive Sciences at the University of California, San Francisco. “Their security is well established.”
The lawsuit, brought by a coalition of anti-abortion national medical associations against the FDA, under the “Hippocratic Medicine Alliance” and several physicians, seeks a series of court actions, primarily an injunction ordering the FDA to “Withdraw mifepristone and misoprostol as FDA-approved drugs for chemical abortion and withdraw defendants’ actions to deregulate these chemical abortion drugs.”
If the lawsuit is successful, an additional 40 million women of reproductive age would lose access to medical abortion services across the country, according to data from abortion rights advocacy group NARAL Pro-Choice America. This number is in addition to the 24.5 million women of reproductive age who live in states that prohibit abortion.
“It goes against decades of scientific and clinical evidence,” says Dana Johnson, a doctoral candidate in public policy and demographics at the University of Texas at Austin, who researches abortion access and health care. “The fact that this lawsuit could undermine something that we know is extremely safe, extremely effective, and is one of the most accessible forms of abortion right now, I think is absolutely terrifying.”
