Texas judge suspends FDA approval of abortion pill; second judge protects access

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Texas judge suspends FDA approval of abortion pill; second judge protects access
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A federal judge in Texas blocked FDA approval of a key abortion pill. In a competing opinion, a federal judge in Washington state ruled separately that mifepristone is safe and effective. The dueling opinions could hasten the issue to Supreme Court.

on behalf of antiabortion medical organizations and four doctors who say they have treated patients with mifepristone. It claims the FDA did not have the power to approve the drug — one of two medications that are used together to terminate a pregnancy — and takes issue with the agency’s easing of restrictions on the pill through the years.

The FDA, he wrote, “took its chemical abortion regimen — which had already culminated in thousands of adverse events suffered by women and girls — and removed what little restrictions protected these women and girls.” The plaintiffs alleged that the FDA wrongly approved mifepristone and that the drug has failed to meet the rigorous federal standards necessary to be prescribed to patients in the United States. Erik Baptist, a lawyer with Alliance Defending Freedom, portrayed the drug as dangerous, saying the “harm of chemical drugs knows no bounds.”

In a brief filed before the hearing, leading organizations of physicians and other public health professionals told Kacsmaryk that reversing FDA approval of mifepristone after 23 years would “cause profound and irreparable harm to patients across the country.” It would be the first time a court ordered the FDA to remove a medication from the market despite opposition from the agency and the drug’s manufacturer.

A few have been stockpiling mifepristone in anticipation of the ruling, hoping they would be permitted to distribute the pills they already have regardless of Kacsmaryk’s decision.

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