Justice Department to appeal decision by Texas judge suspending FDA approval of medication abortion pill
Justice Department to appeal decision by Texas judge suspending FDA approval of medication abortion pill
From CNN’s Mary Kay Mallonee
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.
Federal judge in Washington state case had previously ruled in favor of reproductive rights advocates
From CNN’s Devan Cole
The federal judge in Washington state who issued a ruling Friday in a key abortion lawsuit has previously ruled in favor of reproductive rights advocates in a Trump-era dispute.
US District Judge Thomas Owen Rice was appointed to the Eastern District of Washington in 2011 by President Barack Obama. The Senate confirmed Rice for the post in 2012 by a vote of 93-4.
In his ruling, Rice said the FDA must keep medication abortion drugs available in more than a dozen liberal states that sued the FDA to make the abortion pills more accessible.
The judge previously sided with an abortion rights group when he issued a permanent injunction in 2018 that blocked the Trump administration from slashing grants to a Planned Parenthood program that funds teen pregnancy prevention programs across the country.
Planned Parenthood brought the case against the Trump administration after the government ended Teen Pregnancy Prevention grants for 81 organizations across the nation. The grants to fund the program were supposed to run through 2020, but the Department of Health and Human Services said the grants would end in 2018 instead, arguing that the program was unsuccessful.
“The Court determines that the public interest weighs in favor of (Planned Parenthood), as it would prevent harm to the community … and prevent loss of data regarding the effectiveness of teen pregnancy prevention,” Rice wrote.
Rice served as chief judge of the Eastern District of Washington from 2016 to 2020. Prior to his appointment, Rice had served since 1987 as an assistant US Attorney in Washington.
“This is a significant victory.” Lawyer in Texas medication abortion lawsuit hails Friday’s ruling
From CNN’s Devan Cole
A lawyer representing the plaintiffs in the medication abortion lawsuit in Texas called Friday’s ruling “a significant victory,” but said that he is not yet sure how a separate ruling in a Washington state case could conflict with it.
“The FDA never had the authority to approve these hazardous drugs and remove important safeguards. This is a significant victory for the doctors and medical associations we represent and more importantly, the health and safety of women and girls,” Erik Baptist, an attorney with Alliance Defending Freedom, which is representing the abortion pill challengers, told reporters following the ruling.
Baptist said he has not yet looked at the ruling out of Washington that directly conflicts with the Texas ruling.
“I’m still digesting the court’s decision from the Northern District of Texas. I have not had an opportunity to review the Washington state decision to see how it may or may not impact the court’s decision in our litigation in Texas,” he said.
“I’m not sure whether there’s a direct conflict yet and with the Washington state decision just because I haven’t read it yet, but there may not be a direct conflict,” he added later. “But if there is a direct conflict then there may be – it may be inevitably going to Supreme Court, but I’m not convinced that it’s necessary at this point to make that conclusion.”
Asked about the seven-day stay issued by Kacsmaryk in the case, Baptist said: “The court was recognizing and acknowledging that the government had already asked that and proceeded to give it. So it’s a reasonable relief that the court gave to the government to seek that appeal in the interim.”
White House lawyers are reviewing dueling rulings
From CNN’s Kevin Liptak
White House lawyers are currently reviewing the opposing decisions from judges in Washington and Texas on the FDA’s approval of a medication abortion pill, according to an official.
Vice President Harris calls Texas ruling a “dangerous precedent”
Making her first remarks on a Texas judge’s decision to halt the approval of a medication abortion pill, Vice President Kamala Harris said the decision set “a dangerous precedent.”
Harris spoke to reporters at an airfield in Nashville on Friday after meeting with Democratic lawmakers in Tennessee.
“It is contrary to what makes for good public health policy to allow courts and politicians to tell the FDA what it should do,” Harris said.
The vice president noted the FDA approved the drug, mifepristone, 20 years ago, and said it has been “proven to be safe” in the two decades since.
Harris said she would have more remarks after reviewing the judge’s ruling. President Joe Biden has yet to publicly weigh in on the case.
“As a general matter, I’ll say that there is no question that the president and I are going to stand with the women of America and do everything we can to ensure that women have the ability to make decisions about their health care, their reproductive health care,” Harris said.
Remember: There are two major decisions on medication abortion that came down in short succession this evening. After the Texas judge’s ruling on mifepristone, a second federal judge ruled the drug must remain on the market in more than a dozen Democratic-led states.
The two decisions mark the most significant abortion-related rulings since the Supreme Court overturned Roe v. Wade last year.
CNN’s Sam Fossum contributed to this report.
What the federal judge in Washington state said
From CNN’s Tierney Sneed
In a striking split screen to the ruling out of Texas, where US District Judge Matthew Kacsmaryk in Texas tore apart the process the FDA used to approve the drug, mifepristone, which is the first drug used in a two-drug regime to terminate a pregnancy, Judge Thomas Owen Rice in Washington state took a more deferential tone toward to the FDA, ordering that the status quo be maintained by keeping the drug on the marker.
“It is not the Court’s role to review the scientific evidence and decide whether mifepristone’s benefits outweigh its risks without REMS and/or ETASU. That is precisely FDA’s role,” Rice said. But he said “the record demonstrates potentially internally inconsistent FDA findings regarding mifepristone’s safety profile.”
Here are the states where medication abortion approval isn’t immediately affected
From CNN’s Devan Cole
The states where the approval of mifepristone is not affected, thanks to the ruling from a federal judge Friday in Washington state:
Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania, and Washington, DC.
Dramatic turn of events: Federal judge in Washington state says FDA cannot withdraw mifepristone
From CNN’s Tierney Sneed
In a dramatic turn of events, a federal judge in Washington state said Friday night in a new ruling that the FDA must keep medication abortion drugs available in 17 liberal states and Washington, DC, that sued the FDA to make the abortion pills.
This lawsuit is separate from the ruling that came down in Texas minutes earlier that will halt the approval of the drug. That ruling was paused for seven days, giving the Justice Department time to appeal.
Medical abortion ruling could have long-term impacts on FDA approval and drug manufacturers
A federal judge’s decision could have long-term impacts on the trust in the FDA’s approval process and chill pharmaceutical companies from developing new drugs, according to Elizabeth Cohen, CNN senior medical correspondent.
Mifepristone has about 5 deaths per million users, while other commonly used drugs like Penicillin have about 20 deaths per million users, she said.
“So if this judge is so concerned about side effects, why isn’t he saying let’s take penicillin off the market?” Cohen said.
“This is why decisions are not made by judges. Medical and drug decisions are made by doctors and scientists, by teams of them at the FDA,” she added.
Further, Cohen said a ruling that allows a judge to take a drug off the market could make pharmaceutical companies nervous. She said confidence in scientists at the FDA is critical for the development and creation of new drugs people need.
“If they think that just one judge can take that drug off the market, they may not be willing to invest that kind of money,” Cohen said.
Source: https://www.cnn.com/politics/live-news/texas-abortion-pill-mifepristone-ruling/h_e741ce0292e63ab0e5202b0f76741f03
