Federal judge hears challenge to FDA approval of abortion drug

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Federal judge hears challenge to FDA approval of abortion drug
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New: U.S. District Judge Matthew Kacsmaryk said he would rule “as soon as possible” on the request for a preliminary injunction that would move mifepristone, a common abortion-inducing drug, off the market.

Kathy Thomas, far left, holds a sign that reads “abortion is healthcare” during the Women's March protest outside of the Federal Courthouse in Amarillo on Wednesday., The Texas Tribune’s daily newsletter that keeps readers up to speed on the most essential Texas news.

Lawyers for the Department of Justice and Danco Laboratories, the pharmaceutical company that produces generic mifepristone, argued that the lawsuit is meritless. They also argue the drug was initially approved improperly under an FDA regulation that fast-tracks drugs that treat serious illnesses. The DOJ claims that the statute of limitations on the plaintiffs’ complaints has expired and they have not satisfied the requirements to reopen the FDA’s approval of mifepristone.

In declarations, these medical providers laid out cases where they had to treat patients experiencing adverse effects from medication abortion. There was repeated discussion of an amicus brief filed by the attorney general of Mississippi and signed by the attorneys general of 21 other states, including Texas. That brief argued that the continued approval of mifepristone threatens states’ ability to protect their citizens, and “forces States to devote scarce resources to investigating and prosecuting violations of their laws.”

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