Latest / Bloomberg Law / Alex Pretti's Parents Demand Justice & Copycat Weight Loss Drugs

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Alex Pretti's Parents Demand Justice & Copycat Weight Loss Drugs · Bloomberg Law

• 0:02
  Speaker 1: This is Bloomberg Law with June Grosso from Bloomberg Radio.
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  Speaker 2: Last Saturday marked nine months since our son's murder. We
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  Speaker 2: learned about his death from the media as we saw
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  Speaker 2: him being shot repeatedly in the back after helping a
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  Speaker 2: woman from his community, a fellow Minnesotan who had been
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  Speaker 2: shoved to the ground viciously.
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  Speaker 3: Nine months ago, Alex Preddy, a U.S. citizen, was killed
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  Speaker 3: when federal agents fired at least 10 bullets into his
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  Speaker 3: back in a matter of seconds. The 24-year-old intensive care
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  Speaker 3: nurse had joined the protests against the Trump administration's immigration
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  Speaker 3: crackdown in Minnesota. A video shows him holding a phone
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  Speaker 3: in one hand and trying to shield his face from
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  Speaker 3: pepper spray when he was shoved to the ground by
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  Speaker 3: ICE agents and shot. His mother and father, Susan and
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  Speaker 3: Michael Preddy, say that the federal government has ignored and
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  Speaker 3: misled them and is shielding his killers.
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  Speaker 4: We are here begging for the Department of Justice.
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  Speaker 3: To do what is right, to hold the men who
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  Speaker 3: murdered our son accountable for what they did. The Department
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  Speaker 3: of Homeland Security hasn't announced any developments in the investigation
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  Speaker 3: that may or may not be going on. Preddy's parents
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  Speaker 3: are asking the federal government to hand over evidence so
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  Speaker 3: the state can decide whether or not to charge the agents.
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  Speaker 2: My message to Dan Rosen and Attorney Todd Blanche, look
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  Speaker 2: in your heart and do what is right. Share the
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  Speaker 2: evidence now so prosecutors can follow the facts and hold
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  Speaker 2: these men accountable. Do your job and stop shielding Alex's killers.
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  Speaker 3: Joining me is Leon Fresco, a partner at Holland & Knight.
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  Speaker 3: He was the head of the Office of Immigration Litigation
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  Speaker 3: during the Obama administration. Leon, Freddie's parents say that the
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  Speaker 3: federal government hasn't given them any information about the investigation
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  Speaker 3: into their son's killing and that they didn't even get
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  Speaker 3: a response to a letter they sent to the Justice Department.
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  Speaker 3: Is this unusual?
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  Speaker 1: Well, there is a statute called the Crime Victims' Rights Act,
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  Speaker 1: which is in Title 18 of the U.S. Code, which
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  Speaker 1: gives victims, including the family members of deceased victims, the
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  Speaker 1: rights to confer with the government's attorney and to be
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  Speaker 1: treated with fairness and respect and for timely information. But
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  Speaker 1: the key issue here is the timing. The statute is
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  Speaker 1: usually built around court proceedings. And courts have divided on
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  Speaker 1: whether and how far it's right to touch before charges
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  Speaker 1: are filed. So DOJ's communications come at a later stage.
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  Speaker 1: It's basically their pre-charge position. They're saying that at the
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  Speaker 1: end of the day, this is too early because the
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  Speaker 1: investigation is where everything has to be kept in a bubble.
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  Speaker 1: But if the Pretty family wanted to do something, they
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  Speaker 1: could actually file a mandamus lawsuit in a district court
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  Speaker 1: they can't get any damages, they can't force a prosecution,
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  Speaker 1: but they can try to get a district judge to
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  Speaker 1: basically force them to confer and give them information about
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  Speaker 1: where this case is, where it's going, etc. And if
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  Speaker 1: they get an order like that, then such a meeting
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  Speaker 1: would have to occur.
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  Speaker 3: Another point is that DHS hasn't even retracted the statement
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  Speaker 3: that it issued after the shooting that claimed that Pretty
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  Speaker 3: intended to do maximum damage and massacre law enforcement, so
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  Speaker 3: they haven't even retracted that.
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  Speaker 1: Yes, there were certainly a lot of statements at the
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  Speaker 1: time of this incident talking about Pretty being a terrorist
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  Speaker 1: and intending to do mass harm, etc. And so this
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  Speaker 1: is why the family is understandably concerned with trying to
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  Speaker 1: get the facts out there so that they can once
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  Speaker 1: and for all get a decision. The problem is, of course,
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  Speaker 1: that They have to force this in their own way.
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  Speaker 1: There's nothing that they're going to get just by sort
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  Speaker 1: of asking politely. So they're trying to first try to
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  Speaker 1: see if the media route will work. And then if
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  Speaker 1: the media route doesn't work, they can file this mandamus
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  Speaker 1: lawsuit in the Crime Victims Rights Act. They could try
• 4:27
  Speaker 1: to file a Federal Tort Claims Act case, which would
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  Speaker 1: say that the individuals who engaged in this incident, in
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  Speaker 1: this murder of Alex Pretty, were acting outside of the
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  Speaker 1: scope of their employment and were not supposed to do that.
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  Speaker 1: They basically committed a murder, a cold-blooded murder. They didn't
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  Speaker 1: have any employment reason to do it. And it's tough
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  Speaker 1: because Border Patrol and immigration people are shielded from a
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  Speaker 1: lot of these things, from vivid lawsuits and Federal Tort
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  Speaker 1: Claims Act lawsuits. But nevertheless, that's going to be their
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  Speaker 1: best route to try to get information about this case
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  Speaker 1: and what happened and who's to blame.
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  Speaker 3: Well, Minnesota authorities, law enforcement authorities, are having trouble getting information.
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  Speaker 3: They sued the Justice Department in March, and apparently then
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  Speaker 3: the Justice Department shared some information, but the top prosecutor
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  Speaker 3: in Hennepin County said that was short-lived information. And the
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  Speaker 3: federal government is continuing to withhold information. So they don't
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  Speaker 3: have the gun or the agent's cell phone or even
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  Speaker 3: a statement that one of the agents made. And officially,
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  Speaker 3: they don't even have the agent's names.
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  Speaker 1: Yes, that's correct. The state has another route that's outside
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  Speaker 1: the routes that's available to the parents. And they might
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  Speaker 1: be cooperating. But the point is, the parents don't have
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  Speaker 1: any right to do any prosecutions on their own. But
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  Speaker 1: if the parents and the state are cooperating, the state
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  Speaker 1: can try to launch a prosecution, which again would have
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  Speaker 1: to show that the agents were not acting in a
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  Speaker 1: way that was necessary and proper. And again, essentially we're
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  Speaker 1: committing a cold-blooded murder, not in furtherance of their duties.
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  Speaker 1: And the problem is, as you said, they can't get
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  Speaker 1: the necessary evidence that they need for this case. They
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  Speaker 1: can't get the statement of the agent. They can't get
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  Speaker 1: the weapon that was used in this incident. And so
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  Speaker 1: from that standpoint, the state can't build a case. And
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  Speaker 1: so this is where they then potentially have to go
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  Speaker 1: to a federal court and try to force a decision
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  Speaker 1: from a judge to say that this information is needed,
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  Speaker 1: just like they tried to go before. This is their
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  Speaker 1: only option if the federal government isn't going to cooperate
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  Speaker 1: with them.
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  Speaker 3: I mean, is there even an investigation going on?
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  Speaker 1: Well, this is where the federal government is saying this
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  Speaker 1: is not outside the bounds of a normal time period
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  Speaker 1: for an investigation. And so in the end, this may
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  Speaker 1: have to get litigated and there's going to be an
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  Speaker 1: issue of put up or shut up. What have you
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  Speaker 1: been doing, et cetera. Maybe the judge will ask to
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  Speaker 1: see that in camera and not show that to anyone else,
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  Speaker 1: but just try to check on their own accord what
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  Speaker 1: the Department of Justice is telling them about specific time
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  Speaker 1: periods and specific actions that have been taken within specific
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  Speaker 1: time periods. But At the end of the day, both
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  Speaker 1: the parents of Alex Priddy and the state have very
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  Speaker 1: tough sledding in the world where the federal government doesn't
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  Speaker 1: want to do any cooperation at all. They're going to
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  Speaker 1: need a pretty active court to start giving them information
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  Speaker 1: that wouldn't normally be given. Now, they might be able
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  Speaker 1: to find some judges in Minnesota to do that, but
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  Speaker 1: we're going to have to wait and see.
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  Speaker 3: Have we seen the federal government bring charges against any
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  Speaker 3: of these ice agents who've killed people. You also have
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  Speaker 3: the case of Renee Good, another U.S. citizen who was
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  Speaker 3: shot to death by an ice agent in Minnesota back
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  Speaker 3: in January. The federal government has done nothing there, and
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  Speaker 3: her family ended up filing lawsuits against the federal government
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  Speaker 3: and top DHS officials. I mean, we haven't seen charges
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  Speaker 3: in these cases where people have been killed.
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  Speaker 1: Correct. I think there was one shooting in Texas where
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  Speaker 1: they charged a false statement as opposed to an actual
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  Speaker 1: shooting related charge. But other than that, you're correct.
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  Speaker 2: They haven't.
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  Speaker 1: Really gone after the agents involved. And that's because the
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  Speaker 1: position of this administration is this is a very difficult job.
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  Speaker 1: It's a very stressful job. It's a very unsafe job.
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  Speaker 1: And so the agents need to have vast authority to
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  Speaker 1: be able to perform their duties. And some of these
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  Speaker 1: things are going to happen because people are upset about
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  Speaker 1: immigration enforcement. But The solution is not to penalize the
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  Speaker 1: agents who are trying to do the best job under
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  Speaker 1: the circumstances. Other people look at these exact facts and say,
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  Speaker 1: this is not bad. This is a cold-blooded murder. There's
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  Speaker 1: no excuse for this. And the issue is, will any
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  Speaker 1: of that at all even be reviewed by any court?
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  Speaker 1: Or will the court just say, at the end of
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  Speaker 1: the day, the federal government has broad immunities to conduct
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  Speaker 1: its investigations on its individuals? however it wants, and that's
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  Speaker 1: going to be the end of it. And so we're
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  Speaker 1: going to need to see how that plays out in court.
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  Speaker 1: This is why I think if the parents of Alex
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  Speaker 1: Priddy thought that they had better judicial recourse, they wouldn't
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  Speaker 1: be going to the press like this. They would just
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  Speaker 1: take advantage of whatever judicial recourse they have. There are
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  Speaker 1: certainly many nonprofit legal organizations that would be very happy
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  Speaker 1: to represent them given the high stakes of this case.
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  Speaker 1: So it's not really an issue of lack of legal fees.
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  Speaker 1: It's just an issue that the political solution of really
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  Speaker 1: putting this out there and trying to to sort of
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  Speaker 1: cajole the government through the press to get them to
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  Speaker 1: do the right thing in terms of sharing information and
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  Speaker 1: investigating the case is quite frankly the most efficient and
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  Speaker 1: easiest solution and going to the court is a very
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  Speaker 1: tough slog that's why you're seeing this happen this way
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  Speaker 1: If there's a.
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  Speaker 3: New administration that doesn't want to shield these ICE agents,
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  Speaker 3: can charges be brought against these officers?
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  Speaker 1: Absolutely. The new administration will be well within the five-year
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  Speaker 1: statute of limitations, so they can certainly prosecute any activities
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  Speaker 1: that would have occurred in the Trump administration, unless the
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  Speaker 1: new administration would be not in 2029. but would be
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  Speaker 1: in 2033, then maybe some claims from 2026 would drop,
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  Speaker 1: although not some of the more serious murder claims, if
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  Speaker 1: you have some of those. But, you know, maybe an
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  Speaker 1: assault or a battery type claim or a false statement
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  Speaker 1: claim might drop off of there. But if the administration
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  Speaker 1: were to change in 2028 election and take into effect
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  Speaker 1: in 2029, then anything would go unless, of course, the
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  Speaker 1: Trump administration decides to pardon people. And then in that case,
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  Speaker 1: then the federal agents wouldn't be prosecuted for that. So
• 11:15
  Speaker 1: I think this pardon authority is going to be a
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  Speaker 1: big issue in the next upcoming two years in a
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  Speaker 1: lot of different contexts. And so we're going to have
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  Speaker 1: to see that play out.
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  Speaker 3: I hadn't thought about that. You're so right. That's why
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  Speaker 3: I like to talk to you, Leon. Thanks so much.
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  Speaker 3: That's Leon Fresco of Holland and Knight. Coming up next
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  Speaker 3: on the Bloomberg Law Show, Eli Lilly is trying to
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  Speaker 3: stop black market sales of a new weight loss drug
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  Speaker 3: that hasn't even gotten FDA approval yet. You're listening to Bloomberg.
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  Speaker 2: There's a reason everybody's talking about Reta.
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  Speaker 1: Reta-Truton, the triple agonist. Many call it the strongest fat
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  Speaker 1: loss drug yet.
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  Speaker 4: Oh my God, Sana has prescription Reta.
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  Speaker 3: There are countless ads for the weight loss drug retatrutide
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  Speaker 3: on the Internet, despite the fact that it's an experimental
• 12:03
  Speaker 3: drug that has yet to be approved by the FDA.
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  Speaker 3: Online vendors and wellness clinics have been selling copycat versions
• 12:11
  Speaker 3: of Eli Lilly's experimental drug on the black market, promoting
• 12:16
  Speaker 3: the medication as research-use-only products to bypass scrutiny. But Eli
• 12:22
  Speaker 3: Lilly is taking a hard legal stance and using several
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  Speaker 3: avenues to protect what's expected to be a blockbuster drug
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  Speaker 3: and its obesity franchise. Joining me is FDA regulatory attorney
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  Speaker 3: Edgar Acebe, a partner in Friar Levitt's Life Sciences Practice Group. Edgar,
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  Speaker 3: so this is a weight loss drug by Eli Lilly
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  Speaker 3: that hasn't gotten FDA approval yet. but other companies are
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  Speaker 3: selling counterfeit versions of it on the internet. Explain what's
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  Speaker 3: happening here.
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  Speaker 4: Yeah, let me give you the big context so this
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  Speaker 4: all makes sense. So there was a shortage a few
• 13:00
  Speaker 4: years ago of GLP-1s, of terzepatide and semaglutide. And terzepatide
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  Speaker 4: is made by Lilly like retatrutide. Both of those were
• 13:09
  Speaker 4: approved drugs, but there wasn't enough supply to meet the demand.
• 13:15
  Speaker 4: So FDA... put both of those drugs on the shortage list,
• 13:21
  Speaker 4: which is an official list. And when a drug goes
• 13:24
  Speaker 4: on the shortage list, it means that the branded makers
• 13:29
  Speaker 4: like Novo Nordisk and Lilly, their products went on the
• 13:32
  Speaker 4: shortage list because they couldn't supply enough. And therefore, compounding
• 13:36
  Speaker 4: pharmacies could make essentially copies of that to meet the demand.
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  Speaker 4: And there was no violation of of the patents or
• 13:44
  Speaker 4: of any FDA rules because there was an official shortage.
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  Speaker 4: That shortage ended and compounding pharmacies wanted to keep making
• 13:52
  Speaker 4: those compounded versions, but they could no longer do that lawfully.
• 13:56
  Speaker 4: So FDA sent out warning letters and told these companies,
• 13:59
  Speaker 4: you know, you can't do this anymore. And those companies
• 14:01
  Speaker 4: were also making peptide that you hear about so much.
• 14:04
  Speaker 4: So those same companies decided that they were going to
• 14:07
  Speaker 4: go directly. These are the companies that just buy API
• 14:11
  Speaker 4: from China. repackage it, and sell it for research use only, RUO.
• 14:17
  Speaker 4: So RUO peptides, that's the sector we're talking about. And
• 14:21
  Speaker 4: the guys is, or the facade is, we're selling these
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  Speaker 4: just for research. And on their websites, you have to click,
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  Speaker 4: are you a researcher? You promise to only use for research.
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  Speaker 4: This is not for human use. It's all over the place.
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  Speaker 4: But they sell to individuals, not to Stanford or Harvard
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  Speaker 4: or University of Illinois. They're not selling it to research centers.
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  Speaker 4: They're There's this whole industry in the United States called
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  Speaker 4: the research-use-only peptide companies, thousands of them, that got out
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  Speaker 4: of the gate, bought directly active pharmaceutical ingredient from makers
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  Speaker 4: in China. Some of them, FDA registered, some of them not.
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  Speaker 4: And they sell direct to consumers from their webpages with
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  Speaker 4: no doctor, no prescription, anything. That circumvents the prohibitions on
• 15:08
  Speaker 4: compounding pharmacies. It also, they sell semaglutide and triseptide at
• 15:13
  Speaker 4: greatly reduced prices. But they really got their jump a
• 15:16
  Speaker 4: few years ago, like three, four years ago, when semaglutide
• 15:20
  Speaker 4: and triseptide, you know, Ozempic and Wagovi, all were like
• 15:24
  Speaker 4: $ 1, 200 a month. And these guys were selling it for
• 15:26
  Speaker 4: $ 150 or $ 175 a month. So are they selling these
• 15:28
  Speaker 4: legally then? Or is it a black market?
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  Speaker 3: It is not lawful to sell.
• 15:39
  Speaker 4: Unapproved drugs, which is what these are. Most of the
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  Speaker 4: peptides are unapproved drugs. Terzepatide and semaglutide are approved drugs,
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  Speaker 4: but they have to be sold. You have to get
• 15:50
  Speaker 4: a prescription from your doctor and that's how you get
• 15:52
  Speaker 4: semaglutide and terzepatide. There's a small exception for compounding pharmacies
• 15:58
  Speaker 4: that when a doctor says, I need this semaglutide mixed
• 16:03
  Speaker 4: with B12 or something for this patient in particular, then
• 16:08
  Speaker 4: it's lawful for the compounding pharmacy to formulate that, right?
• 16:12
  Speaker 4: But compounding pharmacies have been using that sort of as
• 16:16
  Speaker 4: an excuse to just continue making terzapatide and semaglutide. And
• 16:19
  Speaker 4: about two months ago, almost two months ago, FDA sent
• 16:23
  Speaker 4: a warning letter to a big compounding pharmacy called Empower,
• 16:26
  Speaker 4: kind of stating, hey, we're onto your game. You can't
• 16:30
  Speaker 4: just add a second component. We consider this just a
• 16:33
  Speaker 4: pretext to continue selling that. So that's for terzapatide and semaglutide.
• 16:38
  Speaker 4: They're trying to narrow that exemption. When it's actually necessary
• 16:41
  Speaker 4: to mix it with something else, that's permitted. But they
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  Speaker 4: were doing this for everybody just so that they could sell, right?
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  Speaker 4: But the research use only sector is 100% outside of
• 16:53
  Speaker 4: the food drug and cosmetic sector. They are not in compliance.
• 16:56
  Speaker 4: It is unlawful to sell for human use any of
• 16:59
  Speaker 4: these peptides or GLP-1s. And that's when we get to
• 17:04
  Speaker 4: Reddit True Times. because these research-use-only peptide companies are already
• 17:11
  Speaker 4: selling peptides for research, quote-unquote, semaglutide and terzepatide for research only, quote-unquote,
• 17:19
  Speaker 4: and retatrutide, because they can access the active pharmaceutical ingredient
• 17:23
  Speaker 4: from China, Chinese API manufacturers. And the drug has not
• 17:27
  Speaker 4: even been approved by FDA. Lilly has spent hundreds of
• 17:31
  Speaker 4: millions of dollars in getting all the clinical trials done,
• 17:35
  Speaker 4: phase one, two, three. And I believe that in the
• 17:38
  Speaker 4: first quarter of next year, they will make their submission
• 17:41
  Speaker 4: to FDA for final approval. But in the meantime, industrious
• 17:47
  Speaker 4: entrepreneurs in the United States who are selling direct to
• 17:50
  Speaker 4: consumer are already selling Reddit True Tide. And that's why
• 17:55
  Speaker 4: we have the very, I'd say, robust response from Lilly
• 18:00
  Speaker 4: to say, hey, hey, hey, you are selling this unlawfully.
• 18:04
  Speaker 4: And this is unfair competition. Those are the state claims
• 18:08
  Speaker 4: that they're making. They're saying you're selling an unlawful drug.
• 18:12
  Speaker 4: And they're basically notifying state and federal authorities, but not
• 18:16
  Speaker 4: just notifying them. You know, they sued 11 companies already
• 18:20
  Speaker 4: for the sale of Reta-Trutide. And they put together files
• 18:23
  Speaker 4: that they share with state attorneys general, state boards of pharmacy, FDA.
• 18:28
  Speaker 4: So they're doing sort of the The work that the
• 18:31
  Speaker 4: federal and the state agencies sometimes don't have the bandwidth
• 18:34
  Speaker 4: to do themselves. And Lilly wants to protect its brand
• 18:39
  Speaker 4: new drug that up until now, they've only spent money developing.
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  Speaker 4: They haven't gotten a dime back in profit yet. And
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  Speaker 4: they already have to go out and protect their brand
• 18:48
  Speaker 4: new and much more efficacious, has a lot of advantages
• 18:52
  Speaker 4: over triseptide and semaglutide. So it's going to be a
• 18:55
  Speaker 4: multi-billion dollar drug. And I think Lilly, quite correctly, is
• 19:00
  Speaker 4: defending its intellectual property and its investment.
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  Speaker 3: So there were 11 suits. They've reached settlements with three
• 19:07
  Speaker 3: that resulted in the termination of all sales, distribution, or
• 19:11
  Speaker 3: marketing of Reddit TrueTide. But one vendor, at least, is
• 19:15
  Speaker 3: saying that they don't have standing.
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  Speaker 4: I think that was a criticism of Lilly's prior approach
• 19:24
  Speaker 4: to That is a correct criticism for what Lilly was
• 19:28
  Speaker 4: doing before when they were defending terzepatide. When they were
• 19:32
  Speaker 4: doing that, they sent thousands of cease and desist letters
• 19:35
  Speaker 4: to companies essentially saying, you're violating the Food, Drug, and
• 19:38
  Speaker 4: Cosmetics Act. And the response was, okay, you're not the FDA.
• 19:44
  Speaker 4: You don't get to enforce the Food, Drug, and Cosmetics Act.
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  Speaker 4: That was true then. That is not what they're doing.
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  Speaker 2: Now.
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  Speaker 4: With Reddit True Tide, they're using state laws, unfair competition,
• 19:55
  Speaker 4: and also a violation of state regulations selling unregistered drug.
• 20:00
  Speaker 4: You know, those are all state violations. They're going to
• 20:03
  Speaker 4: have a lot more traction with these causes of action
• 20:06
  Speaker 4: that they're using. So I don't think lily you don't
• 20:09
  Speaker 4: have standing is any longer the right pushback.
• 20:14
  Speaker 3: So, I mean, it sounds like they have great cases
• 20:17
  Speaker 3: against these vendors.
• 20:20
  Speaker 4: Absolutely. And if regulatory agencies had the bandwidth and the manpower,
• 20:26
  Speaker 4: let's look at FDA, right? The major regulator for approved
• 20:29
  Speaker 4: or unapproved trucks. They send out warning letters all the time, etc.
• 20:33
  Speaker 4: But they lost 3,500 employees under Doge, okay?
• 20:36
  Speaker 2: Yeah.
• 20:39
  Speaker 4: And I've been practicing FDA regulatory law for 24 years.
• 20:43
  Speaker 4: And endemically, FDA has always had not enough budget and
• 20:48
  Speaker 4: not enough bandwidth to properly enforce all the important rules
• 20:53
  Speaker 4: that they're charged with enforcing. Therefore, post-DOJ, they're really hamstrung.
• 20:59
  Speaker 4: And so these are sort of the consequences of all
• 21:01
  Speaker 4: of that in part, right? It's a perfect storm. Number one,
• 21:06
  Speaker 4: because of semaglutide and triseptide and peptides in general, this
• 21:10
  Speaker 4: all came, you know, right after the COVID epidemic. And
• 21:13
  Speaker 4: so what came out of that is this whole new
• 21:15
  Speaker 4: sector and regulators could not close the barn doors soon enough.
• 21:20
  Speaker 4: They're still wide open. And so they're out of hundreds,
• 21:23
  Speaker 4: if not thousands of research use only peptide sellers. And
• 21:27
  Speaker 4: it would take a monumental enforcement action to actually put
• 21:32
  Speaker 4: a dent into where consumers want. And again, the unfortunate
• 21:37
  Speaker 4: thing is that, you know, this all got started five
• 21:40
  Speaker 4: years ago with the influencers, you know, Peter Attia and
• 21:44
  Speaker 4: those guys, the PhD guy from Stanford, those guys were
• 21:48
  Speaker 4: talking about these things because they talk about things scientific,
• 21:51
  Speaker 4: but they're sophisticated enough and they have enough education to
• 21:55
  Speaker 4: understand the difference between there's, you know, animal studies that
• 21:58
  Speaker 4: are very promising, or there's this phase one trial in
• 22:02
  Speaker 4: Germany that promises this and the normal person on the
• 22:08
  Speaker 4: street who's listening to those podcasts thinks, oh, I've got
• 22:11
  Speaker 4: to try this peptide. And there's a lot of caveats
• 22:15
  Speaker 4: and scientists know what those caveats are. And people who
• 22:18
  Speaker 4: are qualified like they are can take informed decisions. But
• 22:25
  Speaker 4: I don't think the average consumer can do that, but
• 22:27
  Speaker 4: it's been an open market. And so they created demand
• 22:31
  Speaker 4: for peptides and GLP-1s in part because And these are
• 22:35
  Speaker 4: all the components that have led to where we are.
• 22:37
  Speaker 4: And there's a lot of caveats and scientists know what
• 22:41
  Speaker 4: those caveats are. And people who are qualified like they
• 22:44
  Speaker 4: are can take informed decisions. But I don't think the
• 22:50
  Speaker 4: average consumer can do that, but it's been an open market.
• 22:53
  Speaker 4: And so they created demand for peptides and GLP-1s in part.
• 22:59
  Speaker 4: And these are all the components that have led to
• 23:00
  Speaker 4: where we are. There was a lot of demand- caused
• 23:04
  Speaker 4: not just by, you know, Huberman and Atiyah, but all
• 23:07
  Speaker 4: the other influencers in the health space that started, jumped
• 23:11
  Speaker 4: on the bandwagon. And all of a sudden, everybody knows
• 23:13
  Speaker 4: about peptides, right? Everybody's talking peptides. And within those peptides
• 23:18
  Speaker 4: in the RUO market, they always include the GLP-1s. So
• 23:22
  Speaker 4: when people say research is only peptides, half their revenues
• 23:25
  Speaker 4: are from the GLP-1s. That's the reality.
• 23:28
  Speaker 3: Coming up next, I'll continue this conversation with Edgar Acebay.
• 23:32
  Speaker 3: How much might Eli Lilly spend defending its drug before
• 23:36
  Speaker 3: it's been approved? This is Bloomberg. Eli Lilly is forming
• 23:43
  Speaker 3: a new battlefront over a weight loss drug that has
• 23:46
  Speaker 3: yet to secure FDA approval. The pharmaceutical giant has filed
• 23:51
  Speaker 3: at least 11 federal lawsuits against a range of online
• 23:55
  Speaker 3: vendors and wellness clinics, making copycat versions of its experimental
• 24:01
  Speaker 3: drug Rhetotrutide, accusing them of illegally selling or facilitating access
• 24:07
  Speaker 3: to a product not approved by any regulator in the world.
• 24:11
  Speaker 3: I've been talking to FDA regulatory attorney Edgar Acebe. So
• 24:16
  Speaker 3: how much can Eli Lilly do to stop those making
• 24:20
  Speaker 3: copycat versions of Rhetotrutide?
• 24:23
  Speaker 4: Well, I think they're going to be much more effective
• 24:26
  Speaker 4: than they were starting a couple of years ago with Terzepatide.
• 24:29
  Speaker 4: You know, when they were pushing back on the terzepatide,
• 24:32
  Speaker 4: you know, the RUO version of terzepatide, they used the
• 24:36
  Speaker 4: argument that I mentioned to you. It was like, you're
• 24:38
  Speaker 4: violating the Food, Drug, and Cosmetics Act. You haven't gone
• 24:40
  Speaker 4: through clinical trials. This is an unapproved drug. And there's
• 24:44
  Speaker 4: no private enforcement of the Food, Drug, and Cosmetics Act.
• 24:47
  Speaker 4: So that had limited success. Lilly learned from that experience.
• 24:51
  Speaker 4: And their lawyers have learned from that experience. And, you know,
• 24:55
  Speaker 4: as a FDA employee, regulatory attorney and having been in
• 24:58
  Speaker 4: this space for a couple of decades, I know that,
• 25:01
  Speaker 4: you know, the obvious cause of action should be you're
• 25:06
  Speaker 4: infringing on our patents. We have patents for Terzapatide, for Redertrutide, right?
• 25:12
  Speaker 4: But if there's a fight between biotech companies and one
• 25:15
  Speaker 4: company says, you're infringing on my patent, the accused company
• 25:20
  Speaker 4: will respond, no, we're not because your patent is invalid.
• 25:23
  Speaker 4: And they'll go to the USPTO and ask for a
• 25:25
  Speaker 4: re-examination of that patent. And many times those patents get
• 25:29
  Speaker 4: narrowed or canceled, right? A good percentage of that. And
• 25:34
  Speaker 4: Lilly would never, would never endanger the patent portfolios that
• 25:40
  Speaker 4: underlie these billion dollar drugs. So they're never using that
• 25:45
  Speaker 4: argument because the counter argument would be, oh, we're going
• 25:48
  Speaker 4: to go and attack your patent. They don't want it.
• 25:51
  Speaker 4: So they never use that cause of action, which you
• 25:53
  Speaker 4: would think would be the logical cause of action. And
• 25:56
  Speaker 4: so they use everything else. Their first attempt was you're
• 26:00
  Speaker 4: violating the Food, Drug, and Cosmetics Act. That didn't work
• 26:02
  Speaker 4: that well. Now what they're doing with state law, unfair competition,
• 26:07
  Speaker 4: and doing the legwork for regulatory agencies by putting files
• 26:12
  Speaker 4: together with all the evidence so that a board of
• 26:16
  Speaker 4: medicine in Iowa or the attorney general in Florida has
• 26:23
  Speaker 4: already a file with all the evidence to initiate an
• 26:26
  Speaker 4: enforcement action. And I think that basically Lilly is doing
• 26:31
  Speaker 4: the legwork for regulatory agencies and giving them something that
• 26:35
  Speaker 4: is going to be much more effective. I've already seen
• 26:38
  Speaker 4: some investigations from state agencies on red or true tide sales.
• 26:44
  Speaker 4: And I know that those are linked to what Lilly
• 26:46
  Speaker 4: is doing. So they have a multi-pronged approach that I
• 26:49
  Speaker 4: think is going to be effective.
• 26:51
  Speaker 3: Do they have any, like, bottom line for how much
• 26:54
  Speaker 3: they'll spend on these, you know, before the drug's even approved?
• 26:58
  Speaker 4: I have no inside information on any of that stuff.
• 27:01
  Speaker 4: But I believe that Terzepatide last year, I could be
• 27:05
  Speaker 4: wrong on this, I think it was like $ 42 billion,
• 27:07
  Speaker 4: something around there, that they sold. Eredotrutide is going to
• 27:10
  Speaker 4: be much bigger. And so, essentially, they have the capital
• 27:15
  Speaker 4: to defend as vigorously as they want to. And they should.
• 27:20
  Speaker 4: You know, they've worked very hard. They've developed this. This
• 27:23
  Speaker 4: is how our system works. But, you know, thousands of
• 27:26
  Speaker 4: horses got out of the barn and we have, you know,
• 27:29
  Speaker 4: three regulators walking by themselves trying to grab one or
• 27:33
  Speaker 4: the other is the way I see it. The demand
• 27:35
  Speaker 4: is there. And I think of it too. It's like
• 27:38
  Speaker 4: the biggest open study in human history. There are thousands
• 27:42
  Speaker 4: of doses of peptides and GLP-1s that are purchased from
• 27:46
  Speaker 4: research use only companies being injected every week by thousands
• 27:52
  Speaker 4: and thousands of people in the United States. I've never
• 27:56
  Speaker 4: in my career seen such a huge uptake of unapproved drugs.
• 28:02
  Speaker 4: These are not coming under a doctor's scrutiny, not coming
• 28:05
  Speaker 4: from a pharmaceutical company, are not FDA approved. But what
• 28:08
  Speaker 4: we're not seeing is the tidal wave of emergency room
• 28:13
  Speaker 4: visits because many times these active pharmaceutical ingredients are the
• 28:18
  Speaker 4: actual drug. Yes, that's the problem. That's why they're so popular.
• 28:24
  Speaker 4: They have not been lawfully acquired through the systems that
• 28:28
  Speaker 4: is complying with the Food Drunk Cosmetics Act, but they
• 28:32
  Speaker 4: get realtors' appetite. I'm not saying all the time because
• 28:35
  Speaker 4: they're not regulated by FDA, so they don't have to
• 28:38
  Speaker 4: operate it at GMP. They don't have to have all
• 28:41
  Speaker 4: the sterility SOPs, but some of them do, and some
• 28:45
  Speaker 4: of them sell stuff that's efficacious according to the users. Now,
• 28:49
  Speaker 4: it's still risky because you might buy from one of
• 28:53
  Speaker 4: these companies that doesn't do all of that. It's hit
• 28:56
  Speaker 4: or miss since they're outside the regulatory system, and that's dangerous.
• 29:00
  Speaker 4: But that's a problem, too, because people who are buying
• 29:04
  Speaker 4: at these very competitive prices, whether it's terzepatide, semaglutide, or eretotrutide,
• 29:10
  Speaker 4: and getting efficacious results without any terrible adverse effects are saying,
• 29:16
  Speaker 4: what's the problem? I can now afford it. I don't
• 29:19
  Speaker 4: know if that's talked about enough, but that's the flip side.
• 29:22
  Speaker 4: So I, as an FDA regulatory attorney, can tell you
• 29:26
  Speaker 4: this is unlawful. This is not followed the safety. There's
• 29:30
  Speaker 4: danger and risk and potential harm in buying from these
• 29:33
  Speaker 4: unregulated markets. But we're not seeing that big avalanche of
• 29:39
  Speaker 4: emergency rooms. in light of the fact that there are
• 29:42
  Speaker 4: thousands and not tens of thousands of doses being self-administered
• 29:46
  Speaker 4: injectables every week. I mean, it sounds incredible.
• 29:49
  Speaker 3: Because everybody wants to lose weight and everybody's looking for
• 29:53
  Speaker 3: an easy way to do it. Lilly is also battling
• 29:57
  Speaker 3: with the FDA. Tell us about that.
• 30:00
  Speaker 4: The other part is the whole argument as to whether
• 30:03
  Speaker 4: FDA is going to classify it as a biologic or
• 30:06
  Speaker 4: as a drug. And that has huge implications. Right now,
• 30:10
  Speaker 4: FDA has determined that it's a drug. It doesn't fit
• 30:13
  Speaker 4: the definition of a biologic. There was a lawsuit, and
• 30:17
  Speaker 4: now it's on appeal. Lilly wants to be classified as
• 30:21
  Speaker 4: a biologic because that gives them 12 years of exclusivity
• 30:24
  Speaker 4: as opposed to five years of exclusivity. It means it
• 30:27
  Speaker 4: can't go generic, right? And if it's a biologic, it
• 30:31
  Speaker 4: could never be compounded. And so all of those affect
• 30:34
  Speaker 4: the bottom line.
• 30:35
  Speaker 3: Who do you think is going to win that battle?
• 30:37
  Speaker 4: Well, it all depends. You know, it's so politicized up
• 30:40
  Speaker 4: in D.C. I spent 15 years in D.C. and I
• 30:42
  Speaker 4: worked at the National Cancer Institute at NIH for four
• 30:45
  Speaker 4: years and I've had friends in the FDA and DEA, etc.
• 30:50
  Speaker 4: And I think it's so highly politicized right now, Washington, D.C.,
• 30:55
  Speaker 4: that it's a little unrecognizable. In normal times, without the
• 30:59
  Speaker 4: level of political influence that there is in the regulatory
• 31:02
  Speaker 4: agencies these days, normal times I would say it is
• 31:06
  Speaker 4: going to be a drug, not a biologic, because it
• 31:08
  Speaker 4: doesn't fit the FDA definition. But if it's remanded by
• 31:12
  Speaker 4: the appeals court and goes back to FDA... I believe
• 31:17
  Speaker 4: that there's an opportunity for FDA, if there's enough pressure
• 31:21
  Speaker 4: on FDA, to redefine what a biologic is to appease Lilly.
• 31:27
  Speaker 3: We've certainly seen other agencies bow to political pressure, so
• 31:32
  Speaker 3: we shall see. Thanks so much for a really interesting conversation, Edgar.
• 31:36
  Speaker 3: That's Edgar Acebe, a partner at Friar Levitt. And that's
• 31:40
  Speaker 3: it for this edition of the Bloomberg Law Show. Remember,
• 31:42
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• 31:45
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• 31:49
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• 31:55
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• 31:58
  Speaker 3: Wall Street time. I'm June Grosso, and you're listening to Bloomberg.