The Daily Dish

Peptide Power Play

This story in The Washington Post was so alarming my tin foil hat almost fell off.

The Trump administration is crafting plans that would allow the temporary sale of certain previously restricted peptides as federal health officials hammer out new regulations around the controversial products, according to two people familiar with the matter who spoke on the condition of anonymity to share private details.

Such a move would allow some compounding pharmacies to dispense certain peptides marketed as new medical treatments and wellness products even as the claims for what they treat have not been fully safety tested.

Holy New England Patriots! Does anyone follow the rules here? This looks complicated, so add an extra shot to that latte, access your pool of residual rage, and let’s get started. First, peptides. Peptides have nothing to do with rip tides, neap tides, or tides at all. Peptides are short chains of amino acids that work with your body and reinforce its natural signals. In contrast, drugs change body chemistry and turn pathways on or off. The popular GLP-1s are peptides.

Compounding pharmacies prepare customized versions of approved medication to meet a specific clinical need – for example, changing a dosage form, removing an allergen, or preparing a formulation that is not commercially available for a particular patient. (Michael Baker explains all things compounding here.)

So, in the world where I don’t wear my tin foil hat to breakfast, need no extras shots, and have no residual rage (maybe), drugs are developed and tested by the Food and Drug Administration (FDA). If approved, they are known to be effective against specific ailments, safe to consume in the prescribed doses, and manufactured in clean settings. Occasionally, they will be altered by compounding pharmacies and delivered in small quantities to people who need a specific variant. (Say, delivery via Twizzlers.)

This is not that world. In this world:

…untested and unapproved wellness peptides that influencers and others have claimed boost longevity or improve physical health have been proliferating in gray and black markets.

The FDA has struggled to keep up with the proliferation of the products, as pharmacy, medical and nursing boards lack the authority and resources to oversee the growing industry, a Washington Post investigation found. This includes schemes such as peptides being made within people’s homes and labels claiming to come from manufacturing facilities that turn out to be empty office space, leaving consumers vulnerable to potentially tainted products.

But fear not! The Alliance for Pharmacy Compounding:

…has been seeking for the FDA to use what’s known as interim enforcement discretion—where the agency essentially acknowledges it will focus its enforcement resources on other matters—to pave the way to let state-licensed compounding pharmacies prepare the drugs for patients with a prescription.

Translation: The FDA will look the other way while safety and efficacy remain untested, so compounding pharmacies can make truckloads of money, er peptides, as long as people have a…prescription. What could go wrong? Isn’t that the strategy that stopped underage drinking?

If there needs to be a separate pathway for the safe and efficacious delivery of peptides to the American populace, then Congress should get right on it. It makes no sense to erect in midstream a jerry-rigged version of the drug delivery pathway that sacrifices safety and bastardizes the role of the compounding pharmacies.

Other than that, it’s all good.

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