![]() "Never before has a judge overruled FDA guidance and recommendations on a drug that's been safely used in this country. "Judges aren't intended to be subject matter experts outside of interpreting the law," Los Angeles attorney Vineet Dubey, co-founder of Custodio and Dubey LLP, told Newsweek. If he finds that the lawsuit has legal ground in front of the court, he might grant an emergency injunction that would temporarily pull the abortion drug from the market. It's rare for a lone judge to challenge the decisions of the FDA-but Kacsmaryk, a Trump appointee, reportedly has a history of backing anti-abortion policies and has written critically of laws allowing abortions. Research backs up the FDA, with studies having consistently shown that mifepristone is safe and effective. It said that removing access to mifepristone would only cause worse health outcomes and harm to patients seeking an abortion. The FDA asked the judge to deny the motion. Kacsmaryk himself won't have much opportunity to intervene in the debate around the safety of mifepristone, as he will have to weigh up a round of procedural questions beforehand. The Texas judge will consider the merits of the lawsuits, specifically whether, as the plaintiffs say, the FDA violated administrative law in the process of approving the abortion drug and recently relaxing the rules around its use. Kacsmaryk will consider the plaintiffs' request for a preliminary injunction that would force the FDA to withdraw or suspend its approval of mifepristone while the lawsuit runs its course. Central Time and is expected to last several hours. "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." "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. "Today, we asked the court to put the health and wellbeing of women and girls first by undoing the harms that FDA has caused by illegally approving dangerous chemical abortion drugs and removing necessary protections," Alliance Defending Freedom Senior Counsel Erik Baptist said, as per a statement sent to Newsweek by the group. The nod was given by the same agency over two decades ago. The challengers, who are represented by prominent anti-abortion organization Alliance for Hippocratic Medicine, also demand that the FDA rescind its approval of mifepristone- one of the two drugs used in medication abortion. ![]() On Wednesday, a Texas federal judge will consider a case brought about by anti-abortion doctors and medical associations that could completely cut off access to medication abortion on a national level. An abortion-rights demonstrator chants slogans as they march near the State Capitol in Austin, Texas, June 25, 2022.
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