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In this exclusive video, Michele Bratcher Goodwin, JD, and Lawrence Gostin, JD, discuss the implications of the mifepristone (Mifeprex) case before the Fifth Circuit Court of Appeals, which is centered on a Texas judge's decision that overturned the FDA's 2000 approval of the abortion medication. As the Supreme Court recently stayed the decision, the drug remains available while the court case plays out.

is currently director of the Center for Biotechnology and Global Health Policy at the University of California Irvine School of Law. She will be joining at Georgetown University's O'Neill Institute for National & Global Health Law, for which Gostin is the director and founding chair. Gostin is also director of the World Health Organization Collaborating Center for National and Global Health Law.

The following is a transcript of their remarks:

Goodwin: So, the mifepristone battle is one that comes nearly a year after the Dobbs [v. Jackson Women's Health Organization] decision. On June 24th, 2022, the United States Supreme Court dismantled Roe v. Wade and Planned Parenthood v. Casey by overturning those cases.

What we've seen in the near year since the Dobbs decision is that a group of petitioners issued a brief desiring that mifepristone be removed from the marketplace. Mifepristone was approved by the Food and Drug Administration in 2000 for use in the termination of pregnancy. [The petitioners'] claim was that they will be overwhelmed by patients who will come to them with health crises after using mifepristone.

So let's talk a little bit more about mifepristone and what it is that the petitioners in this particular case allege.

The first matter was that the FDA rushed the drug through its approval process without a thorough vetting. As it turns out, mifepristone had been reviewed for 54 months before it was released to the marketplace in 2000. By comparison, the other drugs that had undergone review by the FDA that were also approved in 2000 had been under review for about 15 months.

To give you some sense with regard to the claims of health and safety, even decades before the Food and Drug Administration allowed mifepristone in the U.S. marketplace, it had been available in Europe, and studies had shown that it was very safe and had very, very low, almost to non-existent, instances of mortality and morbidity associated with it. That's stunning for a lot of Americans, given so much of the rhetoric that's been around this particular drug.

To speak then to whether we have seen it in the United States to be a drug that is safe for use, in the 23 years since it was approved for the U.S. marketplace, what we've been able to see is that it's a drug that has fewer morbidities than is associated with the use of Tylenol, with the use of penicillin, which is a very important medication, and it is much safer than Viagra. That is another pharmaceutical that many people find to be really important.

Judge [Matthew] Kacsmaryk, the lower court judge in Amarillo, Texas, sided with the petitioners and issued an order a few weeks ago that would remove mifepristone from the U.S. marketplace. This was immediately appealed by the Department of Justice to the Fifth Circuit. The Fifth Circuit allowed it to stay in the marketplace, but with some very serious constraints and conditions.

The DOJ [Department of Justice] then appealed to the United States Supreme Court, and very recently, the Supreme Court issued a ruling allowing mifepristone to stay in the marketplace as it was before Judge Kacsmaryk's decision and pending further review by the Fifth Circuit.

Gostin: I think I would just add this, that the case certainly involves the availability of a highly safe and effective product that's used for abortion. It's also used for miscarriage management and a whole number of things.

If there were restrictions on access to mifepristone it would cause enormous harms, physical harms, [harms to] mental wellbeing and emotional wellbeing, and it would also cost lives. As you know, particularly poorer rural women, many with minority racial backgrounds, are simply having to self-manage their abortion. That's the last thing we want.

But I want to also add the importance of what such a ruling would mean for the whole panoply of FDA-authorized and -approved drugs and vaccines. If you ask the American public just a simple question: "Who would you rather evaluate and make judgments about the safety and effectiveness of your essential drugs and vaccines: career scientists at the FDA or judges?" To ask the question is to answer it. Clearly, nobody wants that, and yet that's what they did. Even the Fifth Circuit.

I fear that if the Supreme Court, when it ultimately hears the case, which I think it probably will, that if they make even a dent into the ability for FDA to make a judgment without looking over their shoulder, it could be open hunting season on the FDA for a whole host of products, starting with messenger-RNA COVID-19 vaccines, but [then] many, many more.

So this has enormous implications. It's one of those series of judgments that really fly in the face of common sense and the rule of law.

For so many reasons, I hope the Supreme Court reverts to some level of sanity and quickly dispenses of this as a frivolous suit. And as Michele says, it has a very obvious off-ramp. It doesn't need to even get to the merits, because clearly these individuals do not have standing by any stretch of the imagination based upon Supreme Court precedent.

Goodwin: The real concern here is, in fact, what this Pandora's box could become. That is to say that petitioners who have a moral objection, a religious objection, who simply don't like certain medications being available, could selectively petition a judge that sits alone in a particular district that has previously expressed certain viewpoints and seek to have a drug removed from the marketplace that meets their religious objection, that meets their moral objection, that they find to be offensive.

As you were mentioning, we are still in the period of a pandemic. During this period of time, while we have seen it's certainly revealed underlying institutional and infrastructural inequalities, it's also revealed that there are many people who think that it's a hoax, many people who do not believe that the COVID vaccines should be in the marketplace.

And in fact, this has been further amplified then by people who now are petitioning that no children should have to receive vaccinations shortly after birth. This is incredibly worrying.

Gostin: If you look at the lower court's opinions in the case we've been talking about, you'll see a horrific lack of sophistication about science.

Somehow, judges think that they can review the quality of a clinical trial, that they can cherry-pick particular anecdotes of risk that somehow the FDA scientists didn't see. They just simply believe that they can, that they have the expertise to understand science, and any scientist who reads those decisions would just have their jaw drop.

You know, the same thing happens in my view with things like the Second Amendment, where the core has now reverted to a historical analysis. What judges don't know about science, they certainly don't know about history. They make these ridiculous historical judgments that are at odds with the vast majority of respected historians, or in this case, scientists.

When they last visited the Second Amendment after having promised that it would be very narrow and there would be a large scope of gun control laws that were allowed, they actually struck down a New York law that had been on the books for over a century. I just do worry about the Supreme Court.

Having said all of that and all of my skepticism about them, and particularly, as Michele pointed out, their almost zealous belief in freedom of religion that trumps any other important value in our society like anti-discrimination, but I think this case is a bridge too far even for this Supreme Court.

I actually think that ultimately, and I'm not sure of this, but I think ultimately the court will just take a convenient off-ramp like the standing issue and not get involved with it, because they know that once they open up Pandora's box, as Michele has said, to other FDA-approved products, there is no limiting principle here.

But I want to add another thing. That is, within hours after the trial judge's decision in this case, there was another case coming out of the state of Washington, where there was a claim made by a number of blue states, and the judge there basically said, "FDA, you can't put any more restrictions on access to mifepristone." And then the Texas case said to the FDA, "You must put more restrictions [on it] and even remove it from the market." The restrictions, of course, survived the Fifth Circuit.

So here you have courts ordering the FDA to march north and south at the same time. They literally cannot abide by these several judgments. How the Supreme Court could tolerate that is amazing. I would've thought that there would've been an immediate, indefinite injunction until the case could be resolved on its merits.

So the fact that [Associate Justice Samuel] Alito played such games for such a long time with cloak-and-dagger midnight deadlines that made people around the country hold their breath and feel insecure, I think, doesn't speak well about the Supreme Court.

Ultimately, the Court had to decide to stay these judgments, because literally how can you ask an agency head like the FDA commissioner to abide by the rule of law when he has no idea what the courts are telling him to do?

Goodwin: Let me build on what Larry just offered, because what he spoke to are the real-world effects of the kind of cloak and dagger, the kind of "by midnight, we'll know more," the holding off until another couple days, something that Justice Alito is more prone to do than any other justice. Justices tend not to say by 5 pm, 6 pm, midnight, these things will happen. It is something that Justice Alito has done.

The effects of this -- I think we should never lose sight of the effects of what it means to be coerced or forced into a pregnancy and what that looks like across the country.

Shortly after the Dobbs decision, we learned of a 10-year-old girl having to flee the state of Ohio to get to Indiana in order to terminate a pregnancy after being serially raped.

We know of in Nebraska a mother and daughter being criminally pursued and charged because a mother gave her daughter advice about terminating a pregnancy.

We know that in Louisiana, there was a Black woman who was denied relief after she found out that her life was at risk and that she was gestating a fetus that had no skull.

We know that in Wisconsin there were patients that bled nearly to death before their doctors felt that they could intervene without the potential of losing their medical license to practice.

In Texas right now, there are five women who are litigating because their lives were placed at risk when they needed pregnancy terminations in order to manage, in one case miscarriage, in another case twins where one of the fetuses had died, placing the other fetus at risk of death as well as the woman.

I could tell you a litany about what's happened in the post-Dobbs landscape, and the mifepristone case is just one example of it.

To be clear, in the Dobbs decision, the Supreme Court said that these would be issues left to the state, to the electoral process. But what we see by Judge Kacsmaryk's ruling from Amarillo, Texas, was that mifepristone would be removed from the market nationwide, meaning that states like California, New York, Illinois, Colorado, and so many more that have become safe havens, they too would suffer in the wake of Judge Kacsmaryk's ruling, placing the Dobbs decision basically at hash.

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