FDA Ivermectin Proceedings Transcript
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[00:00:07] [Ashley Honnold]: And may it please the court,
[00:00:09] [Ashley Honnold]: Ashley Honnold
[00:00:10] [Ashley Honnold]: for the United States.
[00:00:13] [Ashley Honnold]: This case is about informational
[00:00:15] [Ashley Honnold]: statements
[00:00:15] [Ashley Honnold]: made by the US Food and Drug Administration
[00:00:18] [Ashley Honnold]: to inform consumers about the dangers of using certain drugs.
[00:00:23] [Ashley Honnold]: FDA made these statements in response to multiple reports
[00:00:27] [Ashley Honnold]: of consumers being hospitalized
[00:00:30] [Ashley Honnold]: after self medicating
[00:00:31] [Ashley Honnold]: with Ivermectin
[00:00:33] [Ashley Honnold]: intended for horses,
[00:00:34] [Ashley Honnold]: which is available for purchase over the counter
[00:00:38] [Ashley Honnold]: without the need for a prescription.
[00:00:40] [Ashley Honnold]: FDA did not purport to require anyone to do anything
[00:00:45] [Unnamed Speaker 1]: or to prohibit anyone from doing What about when it said no. Stop it.
[00:00:50] [Unnamed Speaker 1]: Why isn't that a command?
[00:00:54] [Unnamed Speaker 1]: That seems to me it's that's the if if you were in English class, they would say that was a command. Stop it.
[00:01:01] [Unnamed Speaker 1]: That is different than we're providing helpful information.
[00:01:06] [Ashley Honnold]: Your honor, the language that the FDA used in these tweets were merely quips,
[00:01:12] [Ashley Honnold]: and I don't think that these quips
[00:01:14] [Unnamed Speaker 2]: change the substance of FDA statements. As as plaintiff's consent Is that a command?
[00:01:22] [Ashley Honnold]: Stop it. The tweets about the horse ivermectin
[00:01:25] [Ashley Honnold]: were intended to advise consumers that they should not use ivermectin
[00:01:29] [Ashley Honnold]: intended for animals and that this could be unsafe.
[00:01:32] [Unnamed Speaker 1]: I'm sorry. Can you answer the question, please?
[00:01:37] [Unnamed Speaker 1]: Is that a command? Stop it.
[00:01:41] [Ashley Honnold]: Your honor, in some context,
[00:01:44] [Ashley Honnold]: those words could be
[00:01:46] [Ashley Honnold]: construed as a a command, but in this context, where
[00:01:50] [Ashley Honnold]: FDA was simply using these words in the context of a quickie tweet meant to share its informational article,
[00:01:58] [Ashley Honnold]: those statements do not rise to the level of a command.
[00:02:02] [Ashley Honnold]: Plaintiffs concede that it was proper for FDA to identify
[00:02:06] [Ashley Honnold]: what Ivermectin is FDA authorized for.
[00:02:10] [Ashley Honnold]: It's FDA approved for certain conditions like
[00:02:14] [Ashley Honnold]: skin conditions or parasites,
[00:02:16] [Ashley Honnold]: and it's not FDA approved for treating COVID.
[00:02:20] [Unnamed Speaker 1]: What other drugs does the FDA
[00:02:23] [Unnamed Speaker 1]: provide information
[00:02:24] [Unnamed Speaker 1]: on that says that it's not
[00:02:29] [Unnamed Speaker 1]: not not approved for other uses?
[00:02:33] [Ashley Honnold]: Sure. FDA makes these kinds of statements all the time, and I'm happy to give the court a few examples. So Please do.
[00:02:41] [Ashley Honnold]: So, for example, FDA can warn the public
[00:02:44] [Ashley Honnold]: that drugs like opioids
[00:02:46] [Ashley Honnold]: are highly addictive and can be dangerous. Although there are
[00:02:51] [Ashley Honnold]: FDA authorized uses for opioids, there are also
[00:02:54] [Ashley Honnold]: dangerous uses, and FDA has to be able to tell the public
[00:02:58] [Unnamed Speaker 1]: in its scientific view that some uses are dangerous. Does it have a scientific view? Has it been through
[00:03:05] [Unnamed Speaker 1]: any type of
[00:03:06] [Unnamed Speaker 1]: scientific testing
[00:03:08] [Unnamed Speaker 1]: or notice in comment or any sort of
[00:03:12] [Unnamed Speaker 1]: doctor review at the FDA that would be a basis for these comments?
[00:03:18] [Ashley Honnold]: Yes, your honor. The FDA does have a scientific
[00:03:21] [Ashley Honnold]: view. It's charged by congress with ensuring that medical
[00:03:25] [Ashley Honnold]: drugs
[00:03:26] [Ashley Honnold]: are safe and effective, and FDA did conduct,
[00:03:30] [Ashley Honnold]: I think scientific analysis as to Ivermectin, but there's What did it do about Ivermectin
[00:03:36] [Unnamed Speaker 1]: bef
[00:03:37] [Unnamed Speaker 1]: that before,
[00:03:38] [Unnamed Speaker 1]: issuing these types of
[00:03:41] [Unnamed Speaker 1]: informational warnings?
[00:03:44] [Ashley Honnold]: Your honor, I don't think there's anything in the record that specifically
[00:03:48] [Ashley Honnold]: tracks FDA's
[00:03:50] [Ashley Honnold]: process,
[00:03:51] [Ashley Honnold]: but for FDA to share information
[00:03:54] [Ashley Honnold]: with the public,
[00:03:55] [Ashley Honnold]: that in its scientific view,
[00:03:59] [Ashley Honnold]: there are dangers with using certain drugs as evidenced
[00:04:02] [Ashley Honnold]: by multiple reports
[00:04:04] [Ashley Honnold]: of consumers being hospitalized
[00:04:06] [Ashley Honnold]: after self medicating with ivermectin intended for horses.
[00:04:10] [Unnamed Speaker 2]: Does FDA does the FDA have any authority, any legal authority, to regulate off label uses of prescription drugs, which is what this would be?
[00:04:20] [Unnamed Speaker 2]: What gives them that authority?
[00:04:22] [Ashley Honnold]: Your honor, FDA has multiple
[00:04:25] [Ashley Honnold]: overlapping sources of authority that I'm happy to walk through that gives FDA
[00:04:30] [Ashley Honnold]: authority to convey information to the public, but here FDA was not regulating
[00:04:36] [Ashley Honnold]: the off label use of drugs.
[00:04:38] [Ashley Honnold]: These statements
[00:04:39] [Ashley Honnold]: are not regulations.
[00:04:41] [Ashley Honnold]: They have no legal consequences.
[00:04:43] [Ashley Honnold]: They don't prohibit doctors
[00:04:45] [Ashley Honnold]: from prescribing Ivermectin
[00:04:47] [Ashley Honnold]: to treat COVID or for any other purpose.
[00:04:50] [Ashley Honnold]: Quite to the contrary, there are 3 instances I'd like to point the court to in the record
[00:04:56] [Ashley Honnold]: that show that FDA explicitly
[00:04:59] [Ashley Honnold]: recognizes that doctors do have the authority
[00:05:03] [Ashley Honnold]: to prescribe
[00:05:04] [Ashley Honnold]: Ivermectin to treat COVID.
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