Appeals court imposes restrictions on abortion pill, but drug will stay on the market for now
Last edited Wed Aug 16, 2023, 08:07 PM - Edit history (2)
Source: CNBC
A federal appeals court on Wednesday imposed restrictions on the abortion pill mifepristone, though the ruling will not have an immediate impact on the medication’s availability. The U.S. Court of Appeals for the 5th Circuit ruled that several decisions the Food and Drug Administration took to make mifepristone more broadly available to women did not take safety concerns into account. The ruling is paused from taking effect until the Supreme Court makes a decision about the case.
The high court imposed the pause in April upon request from the Biden administration after lower courts had ruled against the pill in the spring. If the Supreme Court upholds Wednesday’s ruling, women would no longer be able to obtain the abortion pill through telemedicine appointments and by mail. Patients would have to receive a prescription from a doctor and have three follow-up appointments in person. The restrictions would also shorten the time period when women can take the pill to 49 days into their pregnancy, down from 70 days.
“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” Judge Jennifer Walker Elrod wrote for the court Wednesday. “It failed to consider the cumulative effect of removing several important safeguards at the same time.” The appeals court left the FDA’s underlying 2000 approval of mifepristone and its 2019 authorization of a generic form of the drug in place.
In a dissenting opinion, Judge James Ho argued the appeals court should also have rolled back the FDA’s original approval of mifepristone, an action that would remove the medication from the U.S. market. The American College of Obstetricians and Gynecologists criticized the appeals court decision as “judicial activism.” The medical association said mifepristone is “demonstrably safe and effective” for its FDA-approved use up to 10 weeks of pregnancy.
Read more: https://www.cnbc.com/2023/08/16/abortion-pill-appeals-court-ruling-on-mifepristone.html
Article updated.
Previous articles -
The appeals court Wednesday ruled that the several decisions the Food and Drug Administration took to make the abortion pill more broadly available to women were illegal. If the Supreme Court upholds Wednesday's ruling, women would no longer be able to obtain the abortion pill through telemedicine appointments and by mail. Patients would have to receive a prescription from a doctor and have three follow-up appointments in person. The restrictions would also shorten the time period when women can take the pill to 49 days into their pregnancy, down from 70 days.
"In loosening mifepristone's safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it," Judge Jennifer Walker Elrod wrote for the court Wednesday. "It failed to consider the cumulative effect of removing several important safeguards at the same time." The appeals court left the Food and Drug Administration's underlying 2000 approval of mifepristone and its 2019 authorization of a generic form of the drug in place. In a dissenting opinion, Judge James Ho argued that the appeals court should have also rolled back the FDA's original approval of mifepristone, an action that would remove the medication from the U.S. market.
Mifepristone, used in combination with another drug called misoprostol, is the most common method to terminate a pregnancy in the U.S. The court battle over mifepristone comes more than a year after the Supreme Court abolished federal abortion rights by overturning the landmark 1973 Roe v. Wade ruling. The three-judge panel at the 5th Circuit heard oral arguments in May from the FDA, mifepristone distributor Danco Laboratories, and a group of anti-abortion doctors called the Alliance for Hippocratic Medicine.
If the Supreme Court does not take the case, the restrictions will go into effect. Should the restrictions go in to effect, women would no longer be able to obtain the abortion by mail. Patients would have to receive a prescription from a doctor and have follow-up appointments in person. The restrictions would also shorten the time period when women can take the pill to 49 days into their pregnancy, down from 70 days.
"In loosening mifepristone's safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it," Judge Jennifer Walker Elrod wrote. "It failed to consider the cumulative effect of removing several important safeguards at the same time." The appeals court left the FDA's underlying 2000 approval of mifepristone and its 2019 authorization of a generic form of the drug in place.
Mifepristone, used in combination with another drug called misoprostol, is the most common method to terminate a pregnancy in the U.S. The court battle over mifepristone comes more than a year after the Supreme Court abolished federal abortion rights by overturning the landmark 1973 Roe v. Wade ruling. The ruling Wednesday comes nearly three months after Elrod an two fellow judges at the 5th Circuit heard arguments from the Food and Drug Administration, mifepristone distributor Danco Laboratories, and a group of anti-abortion doctors called the Alliance for Hippocratic Medicine.
If the Supreme Court does not take the case, the restrictions will go into effect. Should the restrictions go in to effect, women would no longer be able to obtain the abortion by mail. Patients would have to receive a prescription from a doctor and have follow-up appointments in person.
The restrictions would also shorten the time period when women can take the pill to 49 days into their pregnancy, down from 70 days. The court battle over mifepristone comes more than a year after the Supreme Court abolished federal abortion rights by overturning the landmark 1973 Roe v. Wade ruling.
Mifepristone, used in combination with another drug called misoprostol, is the most common method to terminate a pregnancy in the U.S. A panel of three judges at the 5th Circuit heard arguments May 17 from lawyers representing the Food and Drug Administration, mifepristone distributor Danco Laboratories, and a group of anti-abortion doctors called the Alliance for Hippocratic Medicine..
Original article -
The court battle over mifepristone comes more than a year after the Supreme Court abolished federal abortion rights by overturning the landmark 1973 Roe v. Wade ruling. Mifepristone, used in combination with another drug called misoprostol, is the most common method to terminate a pregnancy in the U.S.
A panel of three judges at the 5th Circuit heard arguments May 17 from lawyers representing the Food and Drug Administration, mifepristone distributor Danco Laboratories, and a group of anti-abortion doctors called the Alliance for Hippocratic Medicine.
The judges were all appointed by Republican presidents. Judges James Ho and Cory Wilson were appointed by Donald Trump. Judge Jennifer Elrod was appointed by George W. Bush. The FDA and Danco argued that the lawsuit seeking to pull mifepristone from the U.S. market is unprecedented, has no basis in science and will jeopardize women's health.
= new reply since forum marked as read
(just added another update)
I don’t understand how judges have the authority to set rules under which mifepristone can and cannot be used. 
The FDA has expertise and reviews the scientific evidence to provide the basis for rule-making. Judges lack that expertise.
