Federal judge in Texas halts FDA approval of abortion pill mifepristone.
The abortion drug has been widely used in the U.S. since securing FDA approval and there is essentially no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration. Mifepristone is one of two drugs used for in the United States, along with misoprostol, which is also used to treat other medical conditions.
Clinics and doctors that prescribe the two-drug combination have said that if mifepristone were pulled from the market, they would switch to using only the second drug, misoprostol. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies, but it is widely used in countries where mifepristone is illegal or unavailable.
Since the Texas lawsuit was filed in November, legal experts have warned of questionable arguments and factual inaccuracies in the Christian group’s filing. Kacsmaryk essentially agreed with the plaintiffs on all of their major points, including that the FDA didn’t adequately review mifepristone’s safety.
Elsewhere, Kacsmaryk sided with plaintiffs in stating that the FDA overstepped its authority in approving mifepristone, in part, by using a specialized review process reserved for drugs to treat “serious or life-threatening illnesses.” The judge brushed aside FDA arguments that its own regulations make clear that pregnancy is a medical condition that can sometimes be serious and life-threatening, instead calling it a natural process essential to perpetuating human life.
Legal experts warned that the ruling could upend decades of precedent, setting the stage for political groups to overturn other FDA approvals of controversial drugs and vaccines.
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Federal judge in Washington orders feds to keep abortion pill accessA federal judge in Washington state on Friday ordered U.S. authorities not to make any changes that would restrict access to the abortion medication mifepristone in 17 Democratic-led states that sued over the issue, countering a ruling by a judge in Texas on the same day that ordered a hold on federal approval of the drug.
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