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Sydney Lepkin

๐Ÿ‘ค Speaker
273 total appearances

Appearances Over Time

Podcast Appearances

Today, Explained
Skinny and sad on GLP-1s

But that's sort of why we're still seeing a lot of compounding.

Today, Explained
Skinny and sad on GLP-1s

So, well, as far as we know, there isn't a shortage of the pill, but we are seeing, you know, the pill is brand new.

Today, Explained
Skinny and sad on GLP-1s

The pill came to market about a month and a week ago.

Today, Explained
Skinny and sad on GLP-1s

So it was just approved at the end of last year by the FDA.

Today, Explained
Skinny and sad on GLP-1s

It's now just now on the market where you can actually go to a pharmacy as of the beginning of January and pick it up if you had a prescription.

Today, Explained
Skinny and sad on GLP-1s

So seeing last week that HIMSS, the telehealth company and hers, were offering their own version of the compounded pill raises sort of a lot of questions like, can they do that?

Today, Explained
Skinny and sad on GLP-1s

is sort of the question and they will say and initially they said yes we can however very quickly novo nordisk which as you know makes the brand name version of it said you know we're preparing to take legal action because that's illegal it's mass market compounding which is kind of not the you know what compounders are supposed to be doing

Today, Explained
Skinny and sad on GLP-1s

And, you know, we're going to we're going to take action on this.

Today, Explained
Skinny and sad on GLP-1s

And HIMS's response was, you know, that's that's false.

Today, Explained
Skinny and sad on GLP-1s

That's not true.

Today, Explained
Skinny and sad on GLP-1s

Then the commissioner of the Food and Drug Administration, Marnie McCary, tweeted.

Today, Explained
Skinny and sad on GLP-1s

And then that was swiftly followed by an HHS general counsel saying that they were going to refer this issue to the Justice Department.

Today, Explained
Skinny and sad on GLP-1s

So that changed things.

Today, Explained
Skinny and sad on GLP-1s

So now the compounded pill, at least for now, is no longer on the table.

Today, Explained
Skinny and sad on GLP-1s

The short answer is it depends.

Today, Explained
Skinny and sad on GLP-1s

It depends on who is making it.

Today, Explained
Skinny and sad on GLP-1s

It depends on whether they were making it in a sterile environment, whether they're licensed.

Today, Explained
Skinny and sad on GLP-1s

In the case of compounding, it's not, the FDA doesn't typically inspect your sort of small compounders.

Today, Explained
Skinny and sad on GLP-1s

It'll inspect your bigger ones, but a lot of these are made and they're regulated by state boards of pharmacy.

Today, Explained
Skinny and sad on GLP-1s

You know, when a drug goes generic, something called a USP monograph gets made.