Unsurprisingly, reaction from the new HHS policy on the compounding of six unapproved peptides generated immediate reaction from a wide variety of stakeholders. But it’s how the pro-peptide community has reacted that’s worth a second look.
Peptides = Profits
Proponents of the HHS policy were quick to call out its financial impact. Early estimates trickled in on the impact to the peptide market and who is positioned to reap the rewards. Hims was a clear front-runner, and quickly announced the launch for its Peptides+ specialty, already poised for a broader array of unapproved peptides. A look at its disclaimers confirm even more are on the way following “the potential outcome of future Pharmacy Compounding Advisory Committee review of additional peptides.” While not a surprise, it certainly confirms that HHS leadership just opened up Pandora’s Box.
Producers are Pouncing
While the notice of the policy clearly states its effective date being Friday, October 30, manufacturers and users jumped right in. TIME reported the same business day as the initial announcement noting that “shortly after the new notice was published, a number of telehealth websites were already marketing the six peptides, each for a price of anywhere from $199 to $249 a month.” What remains unknown, however, is whether there is supposed to be a lag-time for manufacturing.
Price Fatigue
Some stakeholders have argued the case that this policy clears the way for safer peptide use, but peptide users themselves have taken to social media about their plans to buy the cheaper “research peptides.”
Patient Safety Groups Saw This All Coming
As Americans for Safe and Effective Medicines’ (ASEM) Chief Policy Officer, Fred Mills said on the policy:
“A legal pathway does not resolve problems with untested products, safety risks, questionable ingredients, or misleading claims. In fact, we believe this will worsen what we have already seen – the harms from mass compounding hitting communities hard due to a lack of oversight to rein in bad actors. We need to follow the science, and the reality is that FDA itself has continued to sound the alarm on lackluster data on these peptides. Safety and efficacy aren’t a nice-to-have; they are required. American consumers should not be treated like guinea pigs. It is possible to advance both patient safety and access to legitimate medicines, but this is not it.”?
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About Americans for Safe and Effective Medicines?
Americans for Safe and Effective Medicines (ASEM) is a non-partisan 501(c)(4) non-profit organization dedicated to combating illegal mass compounding, counterfeit products, and misleading marketing practices. ASEM advocates for robust Food and Drug Administration enforcement and legislative and regulatory accountability on behalf of patients.
For more information, please visit safeandeffectivemeds.org and follow us on LinkedIn, X, Instagram, Facebook, and TikTok.