Excerpts from this article:
https://www.texastribune.org/2023/04/07/texas-abortion-drugs-fda-ruling/?utm_source=Texas+Tribune+Newsletters&utm_campaign=3ed6ae2ba2-trib-newsletters-breaking-alert&utm_medium=email&utm_term=0_d9a68d8efc-3ed6ae2ba2-102179957&mc_cid=3ed6ae2ba2&mc_eid=0a4ed7a887
In a potentially devastating blow for abortion access nationwide, a federal judge in Amarillo has stayed the approval of mifepristone, an abortion-inducing drug that has been on the market for more than 20 years.
U.S. District Judge Matthew Kacsmaryk’s ruling will go into effect in seven days, to allow plaintiffs time to appeal the decision.
Kacsmaryk validated virtually every argument brought by the Alliance Defending Freedom, a conservative law firm representing anti-abortion doctors and medical associations who allege harm from treating patients who have used abortion-inducing medication.
Kacsmaryk has deep ties to the anti-abortion movement, and the language in the 67-page ruling, released at 5:30 p.m. Friday, reflects those ties — calling abortion providers “abortionists” and describing the procedure as killing or “starv[ing] the unborn human until death.”
Kacsmaryk also resurfaced an 1800s law that prohibits the mailing of anything related to an abortion, which could have much wider effects than this one lawsuit.
“It is indisputable that chemical abortion drugs are both ‘drug[s]’ and are ‘for producing abortion,’ Kacsmaryk writes. “Therefore, federal criminal law declares they are ‘nonmailable.’”
Almost simultaneously, a federal judge in Washington issued a conflicting ruling that blocks mifepristone from being moved off the market. This federal court conflict will likely move the dispute before the U.S. Supreme Court before long.
Mifepristone, used alongside another drug, misoprostol, is the most common abortion method in the United States.
In states where abortion is legal, clinics will continue to offer surgical procedures and misoprostol-only abortions. Misoprostol is less effective and has more side effects when taken without mifepristone.
This ruling will not change the legality of abortion in Texas, where the procedure has been virtually banned since the overturning of Roe v. Wade in late June. But it will further limit out-of-state options and may have ripple effects for those who seek the medication illicitly.
…In 2019, the FDA approved a generic version of mifepristone, and then in January 2023, after easing some requirements during the pandemic, the FDA permanently lifted the in-person dispensing requirement, allowing the medication to be prescribed through telehealth appointments, dispensed at retail pharmacies and sent through the mail.
… in Texas, nearly all abortion, including medication abortion, is prohibited. In 2021, legislators passed a law specifically making it a felony to mail abortion-inducing medication.
…This suit seeks to remove the drug’s approval nationwide, claiming it was improperly classified as a drug used “in treating serious or life-threatening illnesses” to “provide meaningful therapeutic benefit to patients over existing treatments.”
“But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion,” the lawsuit reads. “In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs.”
…To have “standing” to challenge a law, policy or action, at least one plaintiff must be able to demonstrate they have been harmed. The Alliance Defending Freedom plaintiffs claim that the doctors in their suit have been harmed by having to treat patients who have experienced adverse effects from taking mifepristone.
“What the FDA has done, in illegally approving and then continually deregulating mifepristone, has resulted in doctors being forced, contrary to their most deeply held ethical, medical and religious convictions, to participate and finish elective abortions,” Hawley said.
Kacsmaryk agreed with the Alliance Defending Freedom, writing in his ruling that the “adverse events from chemical abortion drugs can overwhelm the medical system,” and thus, they have associational and organizational standing to bring this suit…
4.7.23 – Texas Tribune
“Federal judge in Texas to suspend the approval of the abortion-inducing drug”
By Eleanor Klibanoff
Excerpts from this article:
https://www.texastribune.org/2023/04/07/texas-abortion-drugs-fda-ruling/?utm_source=Texas+Tribune+Newsletters&utm_campaign=3ed6ae2ba2-trib-newsletters-breaking-alert&utm_medium=email&utm_term=0_d9a68d8efc-3ed6ae2ba2-102179957&mc_cid=3ed6ae2ba2&mc_eid=0a4ed7a887
In a potentially devastating blow for abortion access nationwide, a federal judge in Amarillo has stayed the approval of mifepristone, an abortion-inducing drug that has been on the market for more than 20 years.
U.S. District Judge Matthew Kacsmaryk’s ruling will go into effect in seven days, to allow plaintiffs time to appeal the decision.
Kacsmaryk validated virtually every argument brought by the Alliance Defending Freedom, a conservative law firm representing anti-abortion doctors and medical associations who allege harm from treating patients who have used abortion-inducing medication.
Kacsmaryk has deep ties to the anti-abortion movement, and the language in the 67-page ruling, released at 5:30 p.m. Friday, reflects those ties — calling abortion providers “abortionists” and describing the procedure as killing or “starv[ing] the unborn human until death.”
Kacsmaryk also resurfaced an 1800s law that prohibits the mailing of anything related to an abortion, which could have much wider effects than this one lawsuit.
“It is indisputable that chemical abortion drugs are both ‘drug[s]’ and are ‘for producing abortion,’ Kacsmaryk writes. “Therefore, federal criminal law declares they are ‘nonmailable.’”
Almost simultaneously, a federal judge in Washington issued a conflicting ruling that blocks mifepristone from being moved off the market. This federal court conflict will likely move the dispute before the U.S. Supreme Court before long.
Mifepristone, used alongside another drug, misoprostol, is the most common abortion method in the United States.
In states where abortion is legal, clinics will continue to offer surgical procedures and misoprostol-only abortions. Misoprostol is less effective and has more side effects when taken without mifepristone.
This ruling will not change the legality of abortion in Texas, where the procedure has been virtually banned since the overturning of Roe v. Wade in late June. But it will further limit out-of-state options and may have ripple effects for those who seek the medication illicitly.
…In 2019, the FDA approved a generic version of mifepristone, and then in January 2023, after easing some requirements during the pandemic, the FDA permanently lifted the in-person dispensing requirement, allowing the medication to be prescribed through telehealth appointments, dispensed at retail pharmacies and sent through the mail.
… in Texas, nearly all abortion, including medication abortion, is prohibited. In 2021, legislators passed a law specifically making it a felony to mail abortion-inducing medication.
…This suit seeks to remove the drug’s approval nationwide, claiming it was improperly classified as a drug used “in treating serious or life-threatening illnesses” to “provide meaningful therapeutic benefit to patients over existing treatments.”
“But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion,” the lawsuit reads. “In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs.”
…To have “standing” to challenge a law, policy or action, at least one plaintiff must be able to demonstrate they have been harmed. The Alliance Defending Freedom plaintiffs claim that the doctors in their suit have been harmed by having to treat patients who have experienced adverse effects from taking mifepristone.
“What the FDA has done, in illegally approving and then continually deregulating mifepristone, has resulted in doctors being forced, contrary to their most deeply held ethical, medical and religious convictions, to participate and finish elective abortions,” Hawley said.
Kacsmaryk agreed with the Alliance Defending Freedom, writing in his ruling that the “adverse events from chemical abortion drugs can overwhelm the medical system,” and thus, they have associational and organizational standing to bring this suit…