April 7, 2023 - Texas judge suspends approval of medication abortion pill

The American College of Obstetricians and Gynecologists said in a statement late Friday that a federal judge’s ruling in Texas over mifepristone is “inflammatory” and a “grievous legal overstep.”

“The decision itself betrays the bias and prejudice that informed its rhetoric, which deliberately ignores decades of evidence-based scientific data and eschews clinically appropriate language about mifepristone, a critical medication used for both abortion and miscarriage management,” said the group’s president, Dr. Iffath Abbasi Hoskins, and its CEO, Dr. Maureen Phipps, in the statement.

The US Food and Drug Administration issued the following statement Friday night in response to the ruling of a federal judge in Texas about its approval of mifepristone:

“The FDA has appealed this decision. FDA approved Mifeprex more than 20 years ago based on a comprehensive review of the scientific evidence available and determined that it was safe and effective for its indicated use – medical termination of early pregnancy," the statement read.
"The approval was based on the best available science and done in accordance with the laws that govern our work. FDA stands behind its determination that mifepristone is safe and effective under its approved conditions of use for medical termination of early pregnancy, and believes patients should have access to FDA-approved medications that FDA has determined to be safe and effective for their intended uses.”

President Joe Biden promised late Friday night that his administration will fight against a Texas judge's ruling that seeks to halt the FDA’s approval of a medication abortion pill.

"My Administration will fight this ruling. The Department of Justice has already filed an appeal and will seek an immediate stay of the decision. But let’s be clear – the only way to stop those who are committed to taking away women’s rights and freedoms in every state is to elect a Congress who will pass a law restoring Roe versus Wade," Biden said in a written statement.

The Justice Department filed a notice of appeal Friday night.

A judge’s order that seeks to halt the FDA’s approval of a medication abortion drug has been appealed to a federal appeals court.

Both the Justice Department and Danco, a manufacturer of the drug that intervened in the case, filed notices of appeal to the US 5th Circuit Court of Appeals.

The order halting the approval had already been put on pause for seven days by the judge who handed it down, in order to give the DOJ time to appeal.

Danco Laboratories, the pharmaceutical company that manufactures the abortion pill Mifepristone, released a statement Friday in response to a Texas federal judge issuing a ruling that will suspend the FDA’s two-decade-old approval of the pill.

“This is a dark day for public health, especially for 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,” said Abby Long, Danco’s director of public affairs. 

Long added that the order "fails to account for the meticulous, well-documented FDA decision-making process that led to the initial 2000 approval and the subsequent approvals setting the conditions under which Mifeprex has been distributed for 23 years."

"The court blithely strikes down access to a treatment that is safe and effective and has been essential for millions of people for decades – and that remains legal in many states today," Long said.

Jessica Ellsworth, lead counsel for Danco, said in the statement that Danco plans to appeal the ruling and "feels strongly that the rule of law should prevail in this case, which would result in a reversal of this ruling."

"Today’s decision is wrong on the medicine and science, wrong as a matter of public health policy, wrong as a matter of reproductive rights, and wrong as a matter of law,” Long said. “We will appeal this to the Fifth Circuit and to the Supreme Court, if necessary, while working hard and creatively with FDA, state authorities, healthcare providers, reproductive rights organizations and others to maintain access and do all we can to make Mifeprex available legally.”

A federal judge in Washington state ruled the FDA must keep medication abortion drugs available in more than a dozen Democratic-led states. 

Read the decision here:

New York Democratic Rep. Alexandria Ocasio-Cortez called on President Joe Biden to ignore a Texas judge's ruling halting the approval of a medication abortion pill during an interview with CNN's Anderson Cooper Friday.

The congresswoman said conservative jurists have undermined their legitimacy through the "deeply partisan and unfounded nature" of these rulings.

Ocasio-Cortez said a court's decision "relies on enforcement, and it is up to the Biden administration to enforce — to choose whether or not to enforce such a ruling."

Pushed by Cooper on whether the lawmaker wanted a system where the federal government ignores the judiciary, Ocasio-Cortez said the FDA and the Biden administration will consider the merits of several legal challenges and decide "how exactly we mapped this out."

But the congresswoman said a Republican "power grab" in the judiciary has created a situation in which the legitimacy of their rulings is in doubt.

Asked again if she thinks the Biden administration should flatly ignore the ruling, Ocasio-Cortez said the presidency and Congress can and should act as a check on the judiciary, but she did not outline a specific course of action as it pertains to the Biden administration's tack on the abortion ruling.

Some key context: US District Judge Matthew Kacsmaryk, who made the ruling halting the abortion pill's FDA approval, is an appointee of former President Donald Trump and known as a deeply conservative jurist.

During his presidency, Trump and then-Senate Majority Leader Mitch McConnell placed a heavy focus on confirming more than 200 judicial nominees, leaving a significant imprint on the judiciary that could last for decades.

Ocasio-Cortez said Democrats have been "preparing and anticipating for there being these egregious overreaches by members of the judiciary," saying its a natural progression from Republican efforts to "pack these courts with partisan judges."

Remember: The Texas ruling is on hold for seven days so the federal government can appeal. The decision is complicated further by the ruling of a second federal judge in Washington state, who said the drug must remain on the market in more than a dozen Democratic-led states.

CNN's Ted Barrett contributed to this report.

Organizations and officials are reacting to US District Judge Matthew Kacsmaryk's decision Friday to halt the FDA's approval of the medication abortion pill, mifepristone.

The American Medical Association blasted Kacsmaryk's decision, saying it "flies in the face of science and evidence." 

"The court’s disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm to our patients and undermines the health of the nation. By rejecting medical facts, the court has intruded into the exam room and has intervened in decisions that belong to patients and physicians," said Jack Resneck, Jr., M.D., the group’s president, in a statement. 

The Alliance Defending Freedom called Friday's ruling in the case "a significant victory." But Erik Baptist, an attorney with the group, said he is not yet sure how a separate ruling in a case in Washington could conflict with the ruling.

“The FDA never had the authority to approve these hazardous drugs and remove important safeguards," Baptist said in a statement. "This is a significant victory for the doctors and medical associations we represent and more importantly, the health and safety of women and girls.”

He told reporters he has not yet taken a look at the ruling out of Washington that directly conflicts with the ruling out of Texas. 

Michigan Attorney General Dana Nessel expressed her disappointment in the ruling Friday.

“I am deeply disappointed that Judge Kacsmaryk has decided in favor of those who would harm women by exacerbating our nation’s reproductive healthcare crisis, the stakes of which have only escalated in the aftermath of the fall of Roe," Nessel said.

The Susan B. Anthony Pro-Life America nonprofit called the decision "a win for the health and safety of women and girls."

"The ruling reaffirms that pregnancy is not an illness and abortion is not health care," Finally the FDA is being held accountable for its egregious violation of its own rules to fast-track dangerous abortion drugs to market,” the group's state policy director Katie Glenn said in a statement.

California Gov. Gavin Newsom said the ruling "ignores facts, science, and the law" and puts "the health of millions of women and girls at risk."

"Abortion is still legal and accessible here in California and we won’t stand by as fundamental freedoms are stripped away,” Newsom said in a statement.

Sen. Amy Klobuchar spoke to CNN's Anderson Cooper about the ruling Friday.

“This is just a complete shock for women across the nation," Klobuchar told Cooper. “I think that his ruling, just under the law, makes no sense when you look at FDA law."

Planned Parenthood called Kacsmaryk's decision a "deeply harmful move."

"We should all be enraged that one judge can unilaterally reject medical evidence and overrule the FDA’s approval of a medication that has been safely and effectively used for more than two decades," Alexis McGill Johnson, president and CEO of Planned Parenthood, said in a statement. "This decision could threaten the FDA’s role in this country’s public health system, and — if allowed to stand — will have broad and unprecedented consequences that reach far beyond abortion."

New York Gov. Kathy Hochul said she is "horrified" by the Texas ruling.

"Today's ruling is further evidence that extremists will not just stop at stripping away the right to an abortion," Hochul said in a statement. "Instead, they are actively working, against the will of a vast majority of Americans, to entirely dismantle reproductive health care nationwide."

Connecticut Gov. Ned Lamont called the ruling "another devastating attack on "reproductive rights" and said that it "is about controlling medical decisions that should be between patients and their doctors."

Maine Gov. Janet T. Mills called the decision "reckless" and said it "ignores basic science and facts."

The US Justice Department will appeal the decision by the Texas judge who said he will suspend the FDA’s two-decade-old approval of a medication abortion pill, Attorney General Merrick Garland said in a statement Friday.

US District Judge Matthew Kacsmaryk said he was pausing his ruling for seven days so the federal government could appeal. 

Garland said the department will also review the decision by the judge in Washington state who said in a new ruling that the FDA must keep medication abortion drugs available in more than a dozen states that sued the FDA to make the abortion pills.