PSM statement on ‘deeply concerning’ compounding of GLP-1 weight-loss pills

PSM Executive Director Shabbir Imber Safdar released the following statement in response to news that Hims & Hers is now compounding pill versions of a newly approved GLP-1 weight-loss drug:

“This development is deeply concerning because it shows the speedy ruthlessness with which telehealth companies move to capitalize on the weight-loss drug craze. Using arbitrary ‘personalization’ claims to justify new formulations, these companies are mass-manufacturing unapproved drugs that bypass regulatory safeguards and amount to intellectual property piracy, rather than meeting true individual medical needs. When companies recreate FDA-approved medicines without evidence, oversight, or approval, and sell them directly to the public, it becomes the largest unsanctioned human trial imaginable — underscoring why urgent FDA enforcement and Congressional action are essential to protect patient safety.”

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About the Partnership for Safe Medicines
The Partnership for Safe Medicines is a public health group committed to ensuring the safety of prescription drugs and protecting consumers from counterfeit, substandard, or otherwise unsafe medicines. Comprised of more than 45 non-profit organizations, PSM studies counterfeit drug crime, threats to American patients, and educates the public, policymakers, and health care professionals about threats to the safety of the U.S. drug supply.