Texas judge suspends FDA approval of abortion pill as Washington judge protects it

(AP Photo/Charlie Neibergall)

A much-anticipated ruling was issued Friday from Texas that put on hold the FDA’s approval of mifepristone, an abortion drug that has been approved for use since 2000. A ruling from Washington state later on Friday ruled mifepristone is safe and effective. The competing opinions both came from federal judges, one nominated by Donald Trump and one nominated by Barack Obama.

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U.S. District Judge Matthew J. Kacsmaryk, a nominee of President Donald Trump, ruled first in Texas. He agreed with conservative groups challenging the FDA’s approval of mifepristone as safe and effective. He issued a 67-page opinion.

“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote in the 67-page opinion. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.” He added that the agency had faced “significant political pressure” to “increase ‘access’ to chemical abortion.”

U.S. District Judge Thomas O. Rice, who was nominated by President Barack Obama issued a competing opinion in Washington state. He ordered the FDA to preserve the status quo and continue access in the 17 states, including D.C., that are involved in the second lawsuit that seeks to protect abortion medicine.

This is the first time a judge suspended the medical abortion pill. Judge Kacsmaryk’s ruling was not set to go into effect for seven days to give the government time to appeal. Within hours, DOJ and Danco Laboratories, the drug manufacturer, filed a notice of appeal. AG Merrick Garland said the government would ask the 5th Circuit of Appeals to allow the FDA to maintain the pill’s approval pending the outcome of the case. DOJ was still reviewing the ruling out of Washington state.

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Joe Biden, the most pro-abortion American president ever, criticized the Texas ruling on Friday. He said the court had “substituted its judgment for FDA, the expert agency that approves drugs. If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.” Biden called the decision “another unprecedented step in taking away basic freedoms from women and putting their health at risk.”

Nothing changes today. The judge in Texas paused his ruling for a week while the Biden administration reviews the 5th Circuit ruling and the opposing opinion in Washington state. The administration will likely bring the case to the Supreme Court sooner rather than later. Then the question becomes when the Supreme Court would schedule a hearing. Would it be on an emergency basis and hold a hearing right away or would it be handled as a regular business and be scheduled for a hearing in the new term that begins in October?

Abortion providers have been waiting for Judge Kacsmaryk’s ruling. They say they will provide surgical abortions if the pills are not available or use different medication that includes misoprostol which is currently used as the second drug with mifepristone as a two-step medical abortion process.

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The Texas lawsuit was brought by Alliance Defending Freedom, a legal group working on behalf of pro-life medical organizations and four doctors who say they have treated patients with mifepristone. The group claims the FDA didn’t have the power to approve mifepristone or to ease restrictions on the pill through the years.

Danco, the drug manufacturer, and DOJ call the plaintiff’s claims baseless.

In response to the ruling, Abby Long, Danco’s director of public affairs, said in a statement, “This is a dark day for public health, especially reproductive rights and the reliance on science and medical expertise to guide decisions about what drugs are safe and effective and should be available to patients.” The court’s ruling, she said, “fails to account for the meticulous, well-documented FDA decision-making process.”

Kacsmaryk’s ruling is criticized by pro-abortion voices as showing a pro-life bias. There is concern that a judge can override the FDA’s approval of drugs. Kacsmaryk is almost dismissed in some reporting in an insulting manner – he “seemed aware of the stakes.” Please. The intention here is to make him sound like an idiot, not a member of the judicial community.

Both sides made their cases to Kacsmaryk on March 15 during a four-hour hearing that focused on the technical aspects of federal drug regulation and FDA processes. Kacsmaryk seemed aware of the stakes and how historic this case could be, asking the lawyers about legal precedent and his authority to essentially override the FDA’s approval of a drug more than 20 years ago.

The lawsuit in Washington state was filed in February — three months after the challenge to mifepristone was filed in Texas. Washington Attorney General Bob Ferguson said the FDA imposed too many restrictions on mifepristone and asked the judge to order the federal government to make the medication easier for people to obtain.

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One judge wanted to restrict the abortion drug and one wanted to increase its access. In the meantime, nothing changes today. I fully expect this to head to the Supreme Court as soon as AG Garland can get it over there.

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