FDA Is Unsure About Compounding, but This Nominee Has a View

FDA is in a quandary about compounding of the new obesity drugs, semaglutide and tirzepatide. The U.S. President-Elect has a nominee to lead FDA with a connection to this compounding kerfuffle. Marty Makary is a surgeon and professor at the Johns Hopkins School of Medicine. He is also Chief Medical Officer for the telehealth company known as Sesame.

Sesame sells weight loss services through their telehealth platform, telling prospective patients:

“Shed pounds, save dollars. Weight loss for $249/mo., medication included. The Success by Sesame program includes medication for eligible patients, comprehensive care, provider choice & more – and we never mark up medication prices.

“High-quality, pre-measured compounded semaglutide offered at cost for eligible patients.”

Yes, Dr. Makary should be quite familiar with issues related to compounded obesity medicines.

A Short Supply Opens a Massive Loophole

In case some of you have been living under a rock, let’s remember compounded obesity medicines have turned into tricky issue for FDA. Compounding pokes a hole in the legal monopoly, through patents, that allows Novo Nordisk and Eli Lilly to command high prices for their highly innovative products, semaglutide and tirzepatide. So they don’t like compounding.

But since those companies have fallen short of providing an adequate supply, the FDA says those products are in shortage. This opens a loophole through which compounding pharmacies can drive truckloads of compounded doses of these drugs, sell them at a fraction of the price Novo and Lilly are charging, and still make tidy profits.

A Messy Issue

When FDA tried to say the tirzepatide shortage was over, compounding pharmacies sued. They called the FDA’s action “arbitrary, capricious and contrary to law.” FDA responded with an “oops” and reversed their decision, promising to think it over more carefully. Last week the agency told the court that they still couldn’t decide what to do.

Meanwhile, Novo and Lilly are threatening and suing businesses making and dispensing this stuff. Both FDA and the companies are warning that using a compounded product is risky. Novo and Lilly have each asked FDA to designate their products as too difficult for compounding pharmacies to make.

Doctors have mixed feelings. Some say they would never recommend the a compounded product. Others say it’s the best option in a bad situation for some of their patients.

A Stake in the Game

As the Chief Medical Officer of a company selling compounded semaglutide, it would be tough for Makary to pretend he has no interest in this issue. Presumably Makary will exit his role in the business of selling compounded semaglutide if he gets confirmed as FDA Commissioner. But his prior views will not evaporate.

The Makary nomination is getting cautiously positive reviews.  Jerome Adams, a former U.S. Surgeon General, called him “perhaps the least surprising or controversial of all of Trump’s health picks so far.” Stat News quoted biotech investors as being relieved, saying things like “we dodged a bullet.”

Maybe this would be a good time to remind our readers that RFK Jr. will be Makary’s boss if both of them are confirmed. And he expresses a dim view of semaglutide.

So for many reasons, it seems compounded semaglutide will continue to be a sticky issue for FDA under the new regime.

Click here, here, and here for more on the Makary nomination. For more about RFK on semaglutide, click here.

Funeral of the Anarchist, painting by Carlo Carra / WikiArt

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November 24, 2024