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Supreme Court Hears Oral Arguments in Abortion Pill Case. Aired 10:30-11a ET

Aired March 26, 2024 - 10:30   ET



ELIZABETH B. PRELOGAR, SOLICITOR GENERAL: FDA started by looking at as a comparative analysis, the two periods of time, when you had in- person dispensing and when you didn't and saw that there was no relevant increase in serious adverse events or difference between those two timeframes, so that further supported the safety confusion.

SONIA SOTOMAYOR, U.S. SUPREME COURT JUSTICE: The problem with all drugs is there are complications in virtually all of them.


SOTOMAYOR: At what level the cost-benefit analysis tells you to stop prescribing something is a very difficult question, isn't it?

PRELOGAR: And that's a question that Congress has entrusted to FDA.

SOTOMAYOR: But putting that aside, here, whatever the statistical increase was, FDA determined under the REM standard that it wasn't sufficient to create a risk that counterbalance the need for access, correct?

PRELOGAR: Correct, because FDA has instructed to take into account burdens on the health care delivery system as well and it looked at a variety of sources of data to conclude that on balance the burdens were -- was suggested that it was not necessary to keep this restriction in place to ensure safe use.

SOTOMAYOR: Thank you.


ELENA KAGAN, U.S. SUPREME COURT JUSTICE: General, if I could take you back to the discussion that you were having with Justice Barrett about the conscience objection and just to ask you, I'm sure that you've read the declarations carefully and I'm sure Ms. Holly will have things to say about this too.

But as you read those declarations, what is the conscience objection? What are the doctors objecting to exactly?

PRELOGAR: I think the declarations are specific on this point. There are only seven doctors who regularly practice and submitted evidence. And the declarations are relatively short. This is a J.A. 150 to 200. I encourage reading them because there are only two doctors out of the seven who even provide any information about their specific conscience objections.

KAGAN: Those two are who?

PRELOGAR: Those are Dr. Scop (ph) and Dr. Francis. The relevant language --

KAGAN: The other five don't refer to conscience objections?

PRELOGAR: They don't refer to their own conscience objections or provide any specific detail about exactly what care would violate their conscience. Dr. Francis is at J.A. 155, Dr. Scop (ph) is at J.A. 167, both describe the injury in the same terms. They object to ending the life of a human being in the womb and fear that they might have to complete an abortion for a woman who has an ongoing pregnancy.

KAGAN: So, as you understand those declarations, they do not object to providing whatever care is necessary to a person who may have complications from taking mifepristone? In other words, for example, suppose somebody has bled significantly and needs a transfusion or, you know, any of a number of other things that might happen. As you understand the declarations, there's not an objection to that?

PRELOGAR: I think that the fairest reading of the declarations is they are not objecting to that. Now, I acknowledge that respondents in their red brief have suggested there's a broader conscience injury in play here and that there might be other doctors who have a broader concern about providing any care.

Even if that broader conscience injury had been in this declaration, we think still as a matter of law they could not demonstrate that they have a non-speculative injury. In part because of all of the upstream, things that would have to happen in terms of a woman having the serious event, going to these specific doctors. But also, the fact the federal conscience protections are specifically designed to deal with this issue and they would cover the range of conscience objections that exist in this context.

KAGAN: Right. There are obviously conscience objections of all kinds. I was just asking about the particular declarations of these particular members of the organization.

PRELOGAR: Yes. And I think on these declarations they have not asserted a broader injury. But even if they could conceivably come forward with other doctors or try to adjust their declarations in some way, still that would not suffice.

KAGAN: OK. Can I just ask a quick question about the merits? You open your brief with a somewhat arresting statement, but it starts with to the government's knowledge. And this was written a few months ago. And since then, I'm sure that you've had lots of time to think about this case and to get all background information on it.

So, I'll just read you this sentence and ask you whether it's still true to the government's knowledge. To the government's knowledge. This case marks the first time. And I'm going to say, is it the first time? Is it the only time any court has restricted access to an FDA approved drug by second guessing, FDA's expert judgment about the conditions required to assure that drug safe use? Is it still the only time?

PRELOGAR: That is still, to our knowledge, the only time a court has done that. We have seen a disturbing trend of court sometimes also overriding FDA's judgment to try to grant greater access to drugs when that overrides FDA's expert judgment about what's necessary to ensure safe use. And no matter which direction you come at it from, we on behalf of FDA think that courts have no business making those judgments in the absence of the kind of arbitrary and capricious error that would satisfy the APA.

KAGAN: Thank you.


NEIL GORSUCH, U.S. SUPREME COURT JUSTICE: Just to confirm on the standing issue. Under federal law, no doctors can be forced against their consciences to perform or assist in an abortion, correct?


PRELOGAR: Yes, we think that federal conscience protections provide broad coverage here. Just to be super precise, there are some triggering requirements of receiving federal funding and so forth. We've cited the relevant provisions at page five of our reply brief. The church amendments have the most comprehensive protection here and we think that those amendments guard against the kind of injury that respondents are asserting. There are also state law protections that often apply in this context.

GORSUCH: Thank you.


AMY CONEY BARRETT, U.S. SUPREME COURT JUSTICE: Would that be true even if the declarations were interpreted as respondents do to say that they regard any participation, even transfusions or D&Cs after the abortion is otherwise complete because tissue needs to be removed?

PRELOGAR: Yes, I think that would be true. So, the most relevant church amendment provision is 42 USC 308-7D and its language says that a doctor shall not be required to perform or assist in any part of the health care program that would violate the doctor's religious or moral beliefs. So, it's tied to the nature of the doctor's beliefs rather than particular procedures.

BARRETT: And one other question and this goes to the merits. As I understand it, the serious adverse consequences that have to be reported or that FDA considers risks are death and transfusion but not say -- I mean, it seems to me, and I think the data bears this out, that the elimination of the in-person dispensing requirement or, you know, the in-person visit at the outset would lead to mistakes in gestational aging which could increase the need for a D&C or the amount of bleeding, et cetera. But that does not count, correct, as an adverse event?

PRELOGAR: So, I want to be careful because there's a list of serious adverse events and I'm not sure that I have all of them down to be able to recite them to you, although they're in the record. But I do think the premise of the question is wrong, this idea that the change to in-person dispensing would necessarily increase the risk of those events. That was not reflected in the data that FDA consulted.

And I would point you to J.A. 383 to 384 in particular where FDA explained that even in-person you're not necessarily getting an ultrasound, that's never been required. And so, the relevant question might be, is your provider going to ask you a series of screening questions like when was your last menstrual period in person or via telemedicine? And there's no evident reason why that difference would actually lead to different safety outcomes.

BARRETT: So, there was not even a -- I thought that there was a small percentage increase in the tracking. I'm wrong about that, which I may well be? You know the J.A. way better than I do.

PRELOGAR: Yes. So, I think that with respect to the ER visits, there was some evidence that there were increased ER visits, although as I explained to Justice Alito, that wasn't actually correlated with an increase in serious adverse events.

You know, I don't want to represent all of the different findings of the different studies because they varied a little bit, but FDA's ultimate conclusion was that mifepristone could safely be dispensed without in-person visits. It had voluminous evidence, I think, to support that conclusion in 2021, and there's been no contrary evidence that's been introduced.

BARRETT: So, there was no requirement of either an ultrasound or detecting a fetal heartbeat or anything like that, even before the doctor could just go based on the woman's recounting when her last menstrual period was?

PRELOGAR: That's right. And that dates all the way back to the initial approval of this drug in 2000. It has never been a required condition of use to have an ultrasound. FDA has always left that up to medical judgment.

Now, it is, of course, necessary for providers to be able to diagnose ectopic pregnancy and to date gestational age. That remains true under the REMS now. Prescribers still have to have that capability, and they have to deploy whatever mechanisms they believe would accurately allow them to identify contraindications for use of mifepristone. But it's wrong to suggest that if the court reverses 2021 changes, then every woman's going to get an ultrasound. That's never been the state of play in how this drug has been administered.

BARRETT: How even under the pre-2021 REMS was it possible to detect an ectopic pregnancy without an ultrasound unless the woman was presenting with pain?

PRELOGAR: So, there's a set of screening questions that are often deployed. You can ask things like, do you have unilateral pelvic pain? Did you become pregnant while you had an IUD in or after a tubal ligation? Are you experiencing unusual bleeding? You could ask whether the woman has had a prior ectopic pregnancy. And if the woman has those kinds of risk factors, then imaging may be necessary. But that remains true under the 2021 REMS as well.

The prescriber has to be confident that it has excluded those kinds of conditions before prescribing this drug. And the standard of care around the world, most medication abortion occurs without an ultrasound.

BARRETT: Thanks.


KETANJI BROWN JACKSON, U.S. SUPREME COURT JUSTICE: Good morning, General. So, I'm worried that there is a significant mismatch in this case between the claimed injury and the remedy that's being sought, and that that might or should matter for standing purposes. I don't know that our doctrines sort of capture this, but I guess I see it that the injuries that the respondents allege, as you've articulated them, are a conscience injury, that they are being forced to participate in a medical procedure that they object to.


And so, the obvious common-sense remedy would be to provide them with an exemption, that they don't have to participate in this procedure. And you say, and you've said here several times, that federal law already gives them that. So, I guess then what they're asking for in this lawsuit is more than that. They're saying because we object to having to be forced to participate in this procedure, we're seeking an order preventing anyone from having access to these drugs at all.

And I guess I'm just trying to understand how they could possibly be entitled to that given the injury that they have alleged.

PRELOGAR: I agree, Justice Jackson, and I do think it's relevant to standing. There's a profound mismatch here between the claimed injury and the remedy they were seeking. And, you know, you can almost think of this as a type of zone of interest kind of analysis. You know, if the doctors have a conscience injury, there's a specific statute designed to deal with it, to specifically tailor-made guard against the risk of that injury occurring.

And instead, they're reaching out and seeking to invoke rights under a different statute, the FDCA, that doesn't regulate them at all, that doesn't make them do or not do anything. And the relief that they're seeking would dramatically alter the approved conditions of use for mifepristone and affect women all around the nation simply because of this conscience injury that's already directly addressed by other participants in federal law.

JACKSON: Right. And if it wasn't addressed, then we would see this lawsuit and the remedy would be to exempt them, right? PRELOGAR: Yes. Yes, I mean, I think that one of the hard things about trying to tailor relief here is that they're asserting such a diffuse theory of injury that it's almost as though the only option was to grant a nationwide remedy of the kind the lower courts issued. And that runs counter to ordinary Article III principles of party-specific relief.

But I just think it shows that there's something wrong with the theory of injury in the first place because it's so attenuated and because they claimed they would need so much relief all over the country.

JACKSON: Let me ask you another question. In addition to the challenges that we have here, the respondents below challenged the FDA's initial decision to approve mifepristone in the year 2000. Of course, that occurred a very long time ago. The Fifth Circuit found that that challenge wasn't timely because of the statute of limitations. As you're aware, in the context of another case, we heard this term, the court is currently considering the statute of limitations issue.

So, setting aside standing, have you thought about how a ruling from this court on the statute of limitations, in either direction, might impact what happens in these kinds of cases with these kinds of challenges?

PRELOGAR: Yes, I think that it just reflects the stakes of the corner post case and provides a vivid example of the way that it might be possible if this court is going to happen. or it were to approve the request for a broader theory of the statute of limitations in that case, the way it could open the door to plaintiffs coming in and saying, well, I only became a doctor later, or I only started working in an emergency room later and would try to unsettle longstanding agency actions that maybe occurred decades previously.

I do want to say that I understand the corner post petitioner to have suggested maybe there would be equitable defenses that the government could raise in those kinds of cases. We would certainly want to raise that type of defense with respect to the approval of mifepristone, which I think has generated tremendous reliance interests and proven to be safe and effective over decades of use.

JACKSON: Thank you.

UNIDENTIFIED MALE: Thank you, Counsel. Ms. Ellsworth.

JESSICA L. ELLSWORTH, REPRESENTING DANCO LABORATORIES (MAKER OF ABORTION DRUG): Mr. Chief Justice, and may it please the court. In 2016 and 2021, FDA made certain changes to the labeling and use restrictions for Danco's drug Mifeprex.

The decision below stops Danco from selling Mifeprex in line with that scientific judgment based on a highly attenuated claim that an unknown doctor could be called someday to an unknown emergency room after a series of decisions by third-parties. No facts causally link that possible future encounter to a specific change FDA made in 2016 or 2021. Respondents view of the Food, Drug and Cosmetic Act is so inflexible it would upend not just Mifeprex, but virtually every drug approval and REMS modification FDA has made for decades.

Reversal is required for two reasons. First, Article III standing is not an academic exercise in what's conceivable. Respondents lack standing under every prong of the analysis. Second, on the merits, FDA exhaustively considered the evidence and reasonably explained its conclusions, which is what is required to do. I welcome the court's questions.

CLARENCE THOMAS, U.S. SUPREME COURT JUSTICE: The government -- the solicitor general points out would not be susceptible to a Comstock Act problem, but in your case, you would be.


So, how do you respond to an argument that mailing your product and advertising it would violate the Comstock Act?

ELLSWORTH: Justice Thomas, we agree very much with the government that FDA's charge under the Food, Drug and Cosmetic act is limited to looking at safety and FSC considerations. That's true for new drug approvals. It's also true for REMS modifications.

FDA routinely approves drugs whose manufacture and distribution is restricted by other laws, like the Controlled Substances Act, environmental laws, customs laws, and so on.

I think this court should think hard about the mischief it would invite if it allowed agencies to start taking action based on statutory responsibilities that Congress has assigned to other agencies.

On the merits, this issue was not presented below -- excuse me, it was not ruled on below. And in any event, I would also point out that in 2021, FDA's decision allows use of brick-and-mortar pharmacies in addition to mail order pharmacies.

THOMAS: Well, my problem is that you're private. The government -- I understand the government's argument, but you're private and the statute doesn't have this sort of safe harbor that you're suggesting. And it's fairly broad, and it specifically covers drugs such as yours.

ELLSWORTH: Your Honor, we disagree that that's the correct interpretation of the statute, but we think that in order to address the correct interpretation, there would need to be a situation in which that issue is actually teed up.

This statute has not been enforced for nearly 100 years, and I don't believe that this case presents an opportunity for this court to opine on the reach of the statute.

SAMUEL ALITO, U.S. SUPREME COURT JUSTICE: Counsel -- I'd like to ask you the same questions I was posing to the solicitor general. You know, our precedents, Clapper and Susan B. Anthony List, talk about requiring a substantial risk that harm will recur, and you argue that's not present here. How are we supposed to find the spot at which the risk becomes substantial?

ELLSWORTH: Your Honor, I think this court has always thought about these standing inquiries as really a question of degree, and you're trying to evaluate whether something is actual and imminent, or whether it's conjectural and hypothetical.

And these terms, substantial risk, certainly impending, which has been used dating all the way back to 1923, get at where a claim falls in this spectrum.

ALITO: Right. I mean, we toss around a lot of adjectives, but I'm just trying as a practical matter, how do you figure out? I mean, what percentage of adverse consequences would be enough? What percentage of emergency room visits would be enough?

ELLSWORTH: I think the way Clapper got at that question, and you can see this in footnote five of the opinion, is to really think about whether there is an attenuated chain of contingencies that have to happen. And in situations where there is this kind of attenuated chain of circumstances involving third-party decisions that have to play out in a particular way, and here that chain is quite long, that that squarely puts a plaintiff's theory on the side of the conjectural or hypothetical and not the certainly impending injury.

ALITO: How is your company aggrieved by the challenge that is brought in this case? I gather this is -- your version of mifepristone is the only product you are currently marketing, is that right?

ELLSWORTH: That's correct, Justice Alito.

ALITO: And the Fifth Circuit decision does not prohibit you from continuing to produce and sell that product, right?

ELLSWORTH: That is correct.

ALITO: All right. And so, I gather your injury is that you think you're going to sell more if the restrictions that previously were in place were lifted?


ALITO: So, you're going to make more money?

ELLSWORTH: The injury is that we are prevented from selling our product in line with FDA's scientific judgment about the safe and efficacious use of the drug.

ALITO: And you're going to be harmed because you're going to sell more?

ELLSWORTH: I think that certainly a company's ability to market its product is a part of how it considers the regulatory scheme that governs its conduct. ALITO: During the questioning of the solicitor general, this statement was made that no court has ever previously second guessed the FDA's judgment about access to a drug, right? It's never second guessed that?

ELLSWORTH: That's correct.

ALITO: Do you think the FDA is infallible?

ELLSWORTH: No, Your Honor. We don't think federal and we don't think that question is really teed up in any way in this case.


ALITO: Has the FDA ever approved a drug and then pulled it after experience showed that it had a lot of really serious adverse consequences?

ELLSWORTH: It has certainly done that. And, Your Honor, I think that underscores why the adverse event reporting the post-market surveillance that FDA does, the ability that these plaintiffs have even, if they don't have standing, certainly, if there are -- if they are seeing patients who are presenting with adverse events, if they are doing studies that show there is some unknown safety component that FDA should acknowledge, they can take significant steps to bring that to the agency's attention to bring that to Danco's intention.

ALITO: But don't you think the FDA should have continued to require reporting of non-fatal consequences?

ELLSWORTH: Your Honor, the FDA decided not to continue that reporting requirement in 2016 based on more than 15 years of a well-established safety profile when that reporting was required. There is no drug on the market today, under any realms, that requires the kind of reporting that the plaintiffs are saying should be reimposed here.

ALITO: So, why would that be a bad thing? Wouldn't your company -- I mean, you don't want to sell a product that causes very serious harm to the people who take your product, relying on your tests and the FDA's tests. Wouldn't you want that that data?

ELLSWORTH: Your Honor, that data is certainly something that we are looking for all the time. It is part of the reporting obligations for a manufacturer to be aware of any data that's becoming available through any means.

We have a 1-800 number on our website. There's a 1-800 number on the labeling. I think your honor's question though gets that concern I heard in some of the earlier questioning about who would have standing if these plaintiffs don't have standing. And one of the things I want to note is that drug manufacturers are very frequently subject to tort litigation, product liability suit, failure to warn suits, deceptive advertising suits, when someone is claiming harm from a pharmaceutical manufacturer's product.

What is so, I think, revolutionary, really, about the arguments here, both on standing and the merits, are the way that they attempt by individuals who do not use this product, do not prescribe this product, and have a conscience right not to treat anyone who has taken this product. Those individuals want to prevent anyone else from using it in line with FDA's considered scientific judgment.

ALITO: Does your company -- just one more point, along the same -- sort of along the same lines. Does your company think that what the FDA has done preempts state laws that prohibit the dispensation of mifepristone within their borders?

ELLSWORTH: We have not taken a position on that issue, and it has not been teed up in this case.

ALITO: Well, what is your company's position on it? You haven't even thought about it? One of your competitors made that argument, right?

ELLSWORTH: That's right. There are some lawsuits that have been brought by the generic company that do make that argument, and I think that is for later courts to sort out. Our position in this case has been that this is about FDA's scientific judgments reached in 2016 and 2021.

ALITO: So, you don't want to answer that question?

ELLSWORTH: I don't think we have a position that's on that that I'm prepared to say today.

KAGAN: Could you go back to Justice Alito's questions about adverse event reporting, and you said you were subject, your product, to higher standards and now, were being brought down to the sort of regular? Could you talk about that a little bit? What are the normal standards for adverse event reporting, as you understand them? Why are they there? What, instead, were you subject to in the past?

ELLSWORTH: May I answer the question? Justice Kagan, what changed was not Danco's adverse event reporting responsibility. Danco's adverse event reporting responsibility has been the same throughout this period.

What changed was that from 2000 until 2016, prescribers were obligated to report adverse events to Danco, and then Danco then had its separate reporting obligation to FDA.

So, what -- in 2016, the realm --

JIM ACOSTA, CNN ANCHOR: As the Supreme Court is hearing a case that could radically affect access to the medication pill -- medication abortion in the United States. I want to talk about this with our panel. We've been listening in to all of this. I'm joined now by our CNN Medical Correspondent Meg Tirrell, CNN Chief Legal Analyst Laura Coates, CNN Legal Analyst and Former Federal Prosecutor Elliot Williams, and professor at George Washington University Law School, Sonia Suter. Guys, thank you very much -- ladies and gentlemen, thank you for being with us.

Laura, your sense of these arguments and how they're playing out right now, I mean, not a big shocker, they're playing out pretty much along the lines of this conservative supermajority on the Supreme Court right now.


The conservative justices sort of poking holes in the arguments that the FDA is infallible. We heard Justice Alito say this just a few moments ago to one of the attorneys, I think, for the drugmaker asking, well, do you think that the FDA is infallible? I mean, the arguments have kind of gone along those lines. You're sense at it?

LAURA COATES, CNN CHIEF LEGAL ANALYST AND FORMER FEDERAL PROSECUTOR: Well, let's just take a step back as to why we're here. We obviously know that since the Dobbs decision, the overturning of Roe v. Wade, all eyes have been on politically what different states want to do now that it's returned to the states. This is a case about mifepristone, one in a two-step drug regimen to perform a medication abortion. Nearly half or more are performed in this way using this drug.

The whole point of this is that there was a lower court ruling that said, hold on. The FDA should never have granted access to this drug in the first place. And if they did, they should roll it back to where you could have telemedicine or even have a brick-and-mortar retailer dispense it.

The whole crux of these arguments now is whether, one, the people who brought this, the anti-abortion activists, the divisions have had standing to be here. Do you have an injury before me, or is this perspective in some way about your conscience?

The other side of it is, if they were to decide that the FDA suddenly has to change their rules, only with respect to abortion-related medication, it could have a huge domino effect down the line for all drugs that are prescribed in this country.

And so, the big question for them now is, well, where should we favor? Is the idea of trying to avoid this case entirely, or is it leaning into further this idea that we want to regulate abortion in ways that their Dobbs decision said ought to be left to the states?

ACOSTA: Yes, Meg, I mean, there were some suggestions during the arguments that mifepristone is somehow unsafe. It is one of the safest drugs out there.

MEG TIRRELL, CNN MEDICAL CORRESPONDENT: Yes, and what's really interesting, I mean, this has been around since 2000. There's been a lot of studies done about the safety, and what they've found is that severe adverse events happen in 0.3 percent of cases of folks using this. The efficacy rate they find is 95 percent to 98 percent.

And super interestingly, because this drug is increasingly being used via Telehealth, they find that the safety is the same regardless of whether you're getting this through telemedicine or you're getting this in-person at a clinic.

ACOSTA: And, Sonia, this -- I mean, this flows out of the Dobbs decision.


ACOSTA: The reason why we're listening to this today.

SUTER: Absolutely, it does. So, when Dobbs said that there was no constitutional right to abortion, that left it to the states. But what is happening is that even if abortion is banned in certain states, 14 states have banned, people can still access medication abortion through Telehealth and through the mail.

And so, I think this case is really about trying to control who has access to abortion and reach the people who were able to evade those bans.

ACOSTA: Elliot, your sense of these arguments, how they've broken down. I mean, we've kind of heard the conservative justices trying to poke holes in what is something that is widely accepted across the country as normal reproductive care.

ELLIOT WILLIAMS, CNN LEGAL ANALYST AND FORMER FEDERAL PROSECUTOR: Yes, absolutely. So, picking up on exactly what Laura was saying. You know, there's two big things happening in this case, and it's playing out very clearly in the arguments.

Number one, it's about the world post-Dobbs and post-Roe v. Wade, abortion specifically, and what does it mean in American life, number one. Number two is the role of the administrative state. What power do agencies have to regulate and make decisions on things like drugs or food or air or water?

And a goal, quite frankly, of the conservative movement -- legal movement for the last half century has been the dismantling of the administrative state, and particularly Justice Gorsuch is one that deep in his bones believes that agencies have too much power. Even the FDA ought not to have the juice that it has to regulate.

So, whatever they write here, I would think is going to touch on some of those issues. However -- you know, because the justices are free to write concurrences or dissents or whatever else, and what power agencies have to make decisions is a critical issue and it's going to come up.

ACOSTA: Yes. And, Laura, this really has the potential to chip away further at abortion rights in this country. That's the big implication of this case.

COATES: Yes, if you think that the prior cases or about, whether it's a decision between your doctor and yourself as a woman deciding whether or not to seek out abortion-related services, now this is a question of whether the Supreme Court has a right to dictate what the FDA is able to do in terms of regulations and doling things out.

Remember, the consequences are very big. It's not -- it would not just be mifepristone. If they challenge and say that the FDA ought to have to have a new way of examining and evaluating drugs and how they have to go down the line to figure out whether they're available and how they should regulate that, that's just not just this drug. It should be all of them.

Think about all those that then would leave the marketplace, not just for women reproductive rights, but everyone. That's really the crux of this issue, why Alito was saying, well, hold on, is the FDA infallible?


COATES: I think people leaned in even further to think, well, hold on, is he leaning in that direction to suggest that the FDA somehow is fatally undermined in their credibility? That would be very sweeping.

ACOSTA: All right. Nobody is saying the FDA is infallible. I mean, I don't think anybody has made that argument, but you could hear where the justice was going there when he made that comment.

All right. Laura, Meg, Elliott, Sonia, thank you very much. We'll of course get back to you. A busy morning here on the "CNN Newsroom." Stay with us. We'll be back in just a few moments.

What's that, guys? We're going to the next hour? Oh, we're going to go to the top of the hour.

Thank you for staying with us. You were live in the "CNN Newsroom." I'm Jim Acosta in Washington.