Today, the 5th Circuit Court of Appeals ruled to reinstate several safeguards on the prescription and use of the chemical abortion drug Mifepristone. These safeguards, which the FDA had gradually eliminated without sufficient medical evidence between the time that the drug was first approved in 2000 and 2021, include:
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- Disallowing the sending of chemical abortion drugs through the mail, which the FDA had been allowing since 2021;
- Moving the gestational age limit for the use of Mifepristone back from 10 weeks to 7;
- Requiring in-person doctor visits prior to and after starting a chemical abortion regimen;
- Requiring that patients be checked for complications after starting a chemical abortion.
This ruling decided on an appeal by the Biden administration challenging the April 7 ruling by the U.S. District Court of the Northern District of Texas. This original ruling, made by Judge Matthew Kacsmaryk, stayed the approval of the abortion drug mifepristone, approving a motion by the plaintiffs in the federal case Alliance for Hippocratic Medicine v. FDA. The plaintiffs, of which AAPLOG is one, allege that the FDA broke its own rules and thus the law in its approval of mifepristone in the year 2000. According to Erik Baptist, Senior Counsel for Alliance Defending Medicine, the firm representing the plaintiffs,
The FDA’s approval of chemical abortion drugs over 20 years ago has always stood on shaky legal and moral ground, and after years of evading responsibility, it’s time for the government to do what it’s legally required to do: protect the health and safety of vulnerable women and girls. As we stated in court, the FDA never had the authority to approve these drugs and remove important safeguards, despite the substantial evidence of the harms women and girls who undergo this dangerous drug regimen could suffer.
Here is AAPLOG’s statement on the 5th Circuit Court of Appeals decision:
Today’s ruling is a victory for our patients. Since the drugs Mifepristone and Misoprostol were approved for use in chemical abortions in 2000, the FDA has repeatedly removed necessary safeguards meant to decrease the risk of serious harm to the women who consume them. Today’s 5th Circuit Court of Appeals order reinstating these safeguards for Mifepristone is a first step towards reprioritizing women’s health over the interests of the abortion industry and its allies within our profession. As medical professionals, we will continue to fight for all our patients to be able to receive fully informed consent and the best evidence-based healthcare possible.
Below is AAPLOG’s statement on the U.S. District Court’s original decision:
Today’s ruling in the US District Court for the Northern District of Texas is a victory for all our patients. The FDA began a pattern of prioritizing the interests of the abortion industry over the health and safety of our nation’s women and girls 23 years ago by illegally and recklessly approving dangerous drugs for use in chemical abortions, and then continuing to remove safeguards for women. Today’s ruling places women’s welfare back at the forefront of the conversation on this issue. Our patients deserve excellent healthcare and fully informed consent; this decision helps ensure they receive that.
On the same day as the District Court ruling, a federal judge in the state of Washington issued a conflicting ruling, blocking the FDA from restricting access to the drug in the 16 states that brought the lawsuit.
We will be updating you on the implications of this ruling and the development of AHM v FDA in the coming weeks.
We are so thankful to our excellent legal team at Alliance Defending Freedom (ADF) for clearly presenting the facts of how the FDA approved mifepristone for induced abortion illegally, ignoring the rules and duties given to them by Congress and we hope the 5th Circuit will uphold the ruling that they should be held accountable for that. This is a rapidly developing case that may end up being heard in the U.S. Supreme Court, so we encourage you to follow the latest updates on ADF’s website by clicking here.
