A federal judge suspends FDA's longtime approval of an abortion pill, but gives the government 7 days to appeal

[fords8]

In an unprecedented move, U.S. District Judge Matthew Kacsmaryk on Friday suspended the Food and Drug Administration's longtime approval of key abortion pill mifepristone, though he gave the government a week to appeal his decision. If the ruling does eventually go into effect, it would curtail access to the standard regimen for medication abortion nationwide.

The FDA approved mifepristone more than 20 years ago to be used in combination with a second drug, misoprostol, to terminate pregnancies at up to 10 weeks. Over half of U.S. abortions are done by medication abortion, according to the Guttmacher Institute, a research group that supports abortion rights.

The pills have become increasingly significant in the fights over abortion access that have ensued since Roe v. Wade was overturned.

A coalition of anti-abortion groups, collectively called the Alliance for Hippocratic Medicine, sued in November challenging the process through which the FDA evaluated and approved mifepristone. They argue that the government did not adequately assess the drug’s safety and should not have made it accessible via telehealth during the pandemic.

The plaintiffs sought an injunction to halt the use of mifepristone nationwide while the case plays out, which the judge granted, in part, on Friday.

"The Court does not second-guess FDA’s decision-making lightly," Kacsmaryk wrote. "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."

If the stay on the FDA's mifepristone approval goes into effect, the drug would no longer be available anywhere in the U.S. That would leave a surgical procedure or off-label use of misoprostol on its own as the only options in states where abortion is legal.

Misoprostol, which is not affected by the injunction, is not FDA-approved to terminate pregnancies on its own — doctors would have to prescribe it off-label for that purpose. Some abortion providers said they intend to do that if access to mifepristone is cut off, even though the one-drug approach has been shown in clinical trials to be somewhat less effective than the two-pill regimen.

 

[fords8]

The case could be a new test for the Supreme Court​

The Supreme Court is likely to have the final word on whether the Texas ruling goes into effect.

After the ruling was released on Friday, Attorney General Merrick Garland said the Justice Department strongly disagrees and plans to appeal.

“Today’s decision overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective. The Department will continue to defend the FDA’s decision,” Garland said.

The 5th U.S. Circuit Court of Appeals in New Orleans will consider the appeal first. But even if it does block the ruling, the challengers could ask the Supreme Court to overturn that decision.


So either way, the case is likely to test the Supreme Court's pronouncement last summer when it overturned Roe v. Wade on a 5-4 vote that it was leaving the issue of abortion to the states and other branches of government to decide as a policy question.

In his concurring opinion, Justice Brett Kavanaugh stressed that the ruling “does not prevent the numerous states that readily allow abortion from continuing to allow abortion.”

The votes of Kavanaugh and Chief Justice John Roberts, who voted against overturning Roe, could be pivotal.

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Reactions to the Texas judge's decision​

Vice President Kamala Harris said on Friday that the Biden administration “will 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, in a matter that is what they need, and they decide that, not their government.”

Erik Baptist, senior counsel for the Alliance Defending Freedom, which represents the plaintiffs in the Texas case, said the FDA never had the authority to approve abortion pills.

“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 said.

However, Nancy Northup, president and CEO at the Center for Reproductive Rights, said in a statement that the decision "has no basis in law or fact."

"This lawsuit was manufactured as part of an orchestrated campaign to deny all women in the U.S. access to abortion, even those living in states with strong abortion rights protections," she said.

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An unprecedented legal challenge to the FDA's approval process​

In the lawsuit, the Alliance for Hippocratic Medicine alleges that medication abortion has “potentially serious and life-threatening effects.” However, studies suggest that when mifepristone and misoprostol are used together in consultation with doctors, the regimen successfully terminates pregnancies up to 99.6% of the time and has a 0.4% risk of major complications.

In court filings, the FDA said that it “extensively reviewed the scientific evidence and determined that the benefits of mifepristone outweigh any risks” and that the “public interest would be dramatically harmed” if the drug were removed from the market.

It also called the lawsuit “extraordinary and unprecedented.”

There is little legal precedent for a court to overturn an FDA approval of a drug.

However, some abortion rights advocates expected this decision from Kacsmaryk, a Trump appointee who earlier in his career represented a Christian conservative legal group called First Liberty Institute. The group sued the federal government challenging the part of the Affordable Care Act that required employers to provide free insurance coverage for birth control.

The legal fight over abortion pills going forward may be complicated by a second ruling that came minutes after the Texas decision. In a separate case, a federal judge in Washington state issued a preliminary injunction barring the FDA from "altering the status quo and rights as it relates to the availability of mifepristone."

In that case, a coalition of Democratic attorneys general in February challenged the FDA’s regulations on mifepristone and asked the court to remove “unnecessary” restrictions that could limit access to it.

However, the ruling from the judge in Washington state applies only to the 18 states that sued.

 

[~ True Legend ~]

This abortion pill was previously found to be safe, this appears to be a political vendetta rather than a decision with a scientific basis.
What disgusts me is that there is no federal statutory protection to abortion even in cases of rape or incest.

Texas abortion: US appeals court reinstates near total ban

It comes two days after a lower court blocked the law, which bans abortions at six weeks of pregnancy.

www.bbc.co.uk

It gives any individual the right to sue anyone involved with providing or facilitating an abortion after cardiac activity is detected, and makes no exceptions for pregnancies caused by rape or incest.

Thanks for sharing this article - interesting update!

 

[~ True Legend ~]

@fords8 out of curiosity are you a supporter of abortion rights?
Curious as to your thoughts too @Web Diva

Anyone else, please feel free to add your views

 

[fords8]

@fords8 out of curiosity are you a supporter of abortion rights?

I think if a women and a man choose to have sex and get pregnant that it isn't the baby's fault that it happened. If a person can't take care of a kid, maybe giving the child up is an option. If rape or incest or a woman's life is at risk, then within a certain time it is fine.

I guess that is the short version of it for me. I never had to deal with it in my life either. If I did, I may feel different about it.

 

[~ True Legend ~]

I think if a women and a man choose to have sex and get pregnant that it isn't the baby's fault that it happened. If a person can't take care of a kid, maybe giving the child up is an option. If rape or incest or a woman's life is at risk, then within a certain time it is fine.

I guess that is the short version of it for me. I never had to deal with it in my life either. If I did, I may feel different about it.

100%. I feel the same way. I think people should research exactly what pregnancy involves prior to getting pregnant

Thanks for sharing your view
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What if the mother is diagnosed with a condition which carries a genetic risk?
Would you believe in abortion in that instance, or taking care of a baby bound to have a poor quality of life?
Interested in your view @fords8 and anyone else

 

[Heatman]

I think if a women and a man choose to have sex and get pregnant that it isn't the baby's fault that it happened. If a person can't take care of a kid, maybe giving the child up is an option. If rape or incest or a woman's life is at risk, then within a certain time it is fine.

I guess that is the short version of it for me. I never had to deal with it in my life either. If I did, I may feel different about it.

This is exactly the same way I feel about abortions. You can't force an unborn child to suffer for your actions. When you have s*x without condom, you know that pregnancy might come up. In such cases, I'm never support of abortions.

 

[~ True Legend ~]

This is exactly the same way I feel about abortions. You can't force an unborn child to suffer for your actions. When you have s*x without condom, you know that pregnancy might come up. In such cases, I'm never support of abortions.

Does this ever happen though?

 

[magnus2022]

Abortion is a serious issue and should be not be treated with kid's gloves. There is need that government should banned the use of the drugs until proper clinical trials are conducted. Secondly, it is very sad that these drugs can be find in over the counter in pharmaceutical stores

 

[Heatman]

Does this ever happen though?

Do you mean like does one get pregnant when they have s*x without condom? It's a natural law if that's what you're asking about. Although, artificial insemination is another method one can get pregnant with but that's a planned method.