Falsa Fides in Me Semper Est

Cheap Copies of Semaglutide Under Scrutiny

Semaglutide for the treatment of obesity continues to be in short supply. Late last week, Novo Nordisk announced that, because the company is still having difficulty keeping up with demand, they would limit production of the lower doses used to start patients on Wegovy. Thus, compounding pharmacies are selling cheap copies of semaglutide injection and that practice is coming under scrutiny from regulators.

Warnings from State Regulators

State boards of pharmacy in Louisiana, Mississippi, North Carolina, and West Virginia are warning against using forms of semaglutide that are not known to be safe and effective for human use. One concern is the possibility that these compounding pharmacies might be using a sodium salt of semaglutide, which FDA has not approved for use in any drug. The West Virginia Board of Pharmacy explained:

“Compounding a commercially available product is allowable only in certain narrow circumstances. Even when the compounding of a semaglutide drug product is allowed under the FD&C Act, the use of semaglutide salts, the use of any non-pharmaceutical grade API, or one not produced by an FDA-registered establishment, is prohibited.

“The Board is charged with protecting the public. Therefore, compounding semaglutide drug products in a way that fails to conform with governing law may lead to enforcement action.”

Obesity medicine physicians are likewise skeptical. Karl Nadolsky told MedPage Today:

“I can tell you, the consensus amongst legitimate practicing obesity endocrinology specialists is to avoid this, because it’s just too much unknown.”

High Costs, Limited Availability, and Difficulties for Patients

Two factors contribute to the desperation of people buying these cheap semaglutide copies that prompt regulatory scrutiny. First is the high price, low volume strategy of the legitimate drug’s manufacturer. Daniel Drucker, who played a big role in the discovery of GLP-1 agonists like semaglutide, recently described it to Bloomberg:

“When they [companies approved to these drugs] run the models, they make more money selling fewer units for higher costs,”

Add that to the fact that drug plans are dragging their feet on paying for semaglutide. Thus patients face daunting costs for a drug that has the potential to overcome a major health problem for them.

Apart from the pricing, an inadequate supply is the other major factor that drives people to consider dubious sources for semaglutide.

All of this adds up to a lot of profits and yet a lot of pressure to explain a commercial strategy for this innovative drug that isn’t working especially well for patients.

Click here for more on scrutiny of compounding pharmacies and here for more on the difficulties for patients.

Falsa Fides in Me Semper Est, photograph by Giovanni Dall’Orto. Allegory of fraud in capital #12 on the portico of Palazzo Ducale in Venice.

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TITLE, painting by ARTIST / WikiArt

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May 8, 2023