#USA
#Washington
#Americans for Safe
#Effective Medicines
#Compounded GLP-1 drugs
#Drug Safety Advocacy
Americans for Safe and Effective Medicines Launches to Combat Counterfeit Drugs and Misleading Marketing Practices
On July 14, 2026, Americans for Safe and Effective Medicines (ASEM) officially launched as a new national advocacy organization with a mission to protect patients from illegal mass compounding, counterfeit products, and misleading marketing practices. The urgency of this initiative is underscored by a recent national survey revealing that while 84% of consumers express a desire for their GLP-1 medications to be FDA-approved, only 17% are aware that compounded GLP-1 products lack such approval.
The findings from ASEM’s inaugural survey highlight a significant disconnect between consumer expectations and their understanding of compounded medications. Notably, among current users of GLP-1 medications, a majority mistakenly believe that these compounded products carry FDA approval, pointing to a widespread lack of awareness that could jeopardize patient safety.
Fred Mills, Chief Policy Officer at ASEM, explained the mission of the organization: "Patients are being asked to take all the risk without being given all the facts. ASEM was created to protect patients from a marketplace where confusion has become a profit center. Compounding was designed to solve individual patient problems, not to become a business model built on patient confusion."
Furthermore, 82% of primary care physicians reported encountering patients who were unaware that compounded products lack FDA approval. ASEM's recent report, titled "The Shortage is Over. The Risks Are Not—How Illegal Mass Compounding Is Undermining Patient Safety—and What Must Happen Next," highlights the concerning evolution of temporary compounding practices into an unregulated market for counterfeit GLP-1 products. The report stresses that misleading marketing practices obscure the essential differences between compounded products and FDA-approved medicines, contributing to a growing culture of patient confusion and risk.
The report also outlines critical issues related to patient safety that have arisen from industrial-scale distribution of non-FDA-approved products. These include concerns regarding quality, sterility, and sourcing of ingredients in mass-compounded injectable medications. The distribution channels for these products have become increasingly blurred, as telehealth platforms, medical spas, and online sellers aggressively market these alternatives, further complicating the landscape for consumers.
ASEM calls for robust enforcement by the FDA and accountability in both legislative and regulatory frameworks to safeguard patients from the dangers posed by these counterfeit alternatives. The organization operates as a non-partisan 501(c)(4) non-profit, committed to advocating for patients' rights and safety in an increasingly complex healthcare environment.
For patients, the implications of ASEM's work are profound. As the organization aims to bridge the gap between consumer expectations and reality, it underscores the importance of transparency in healthcare practices. With increased awareness and advocacy, ASEM strives to empower patients to make informed choices about their health and medications.
To learn more about ASEM's mission and efforts, individuals can visit their official website at safeandeffectivemeds.org and connect with them on social media platforms like LinkedIn, X, Instagram, Facebook, and TikTok.
The findings from ASEM’s inaugural survey highlight a significant disconnect between consumer expectations and their understanding of compounded medications. Notably, among current users of GLP-1 medications, a majority mistakenly believe that these compounded products carry FDA approval, pointing to a widespread lack of awareness that could jeopardize patient safety.
Fred Mills, Chief Policy Officer at ASEM, explained the mission of the organization: "Patients are being asked to take all the risk without being given all the facts. ASEM was created to protect patients from a marketplace where confusion has become a profit center. Compounding was designed to solve individual patient problems, not to become a business model built on patient confusion."
Furthermore, 82% of primary care physicians reported encountering patients who were unaware that compounded products lack FDA approval. ASEM's recent report, titled "The Shortage is Over. The Risks Are Not—How Illegal Mass Compounding Is Undermining Patient Safety—and What Must Happen Next," highlights the concerning evolution of temporary compounding practices into an unregulated market for counterfeit GLP-1 products. The report stresses that misleading marketing practices obscure the essential differences between compounded products and FDA-approved medicines, contributing to a growing culture of patient confusion and risk.
The report also outlines critical issues related to patient safety that have arisen from industrial-scale distribution of non-FDA-approved products. These include concerns regarding quality, sterility, and sourcing of ingredients in mass-compounded injectable medications. The distribution channels for these products have become increasingly blurred, as telehealth platforms, medical spas, and online sellers aggressively market these alternatives, further complicating the landscape for consumers.
ASEM calls for robust enforcement by the FDA and accountability in both legislative and regulatory frameworks to safeguard patients from the dangers posed by these counterfeit alternatives. The organization operates as a non-partisan 501(c)(4) non-profit, committed to advocating for patients' rights and safety in an increasingly complex healthcare environment.
For patients, the implications of ASEM's work are profound. As the organization aims to bridge the gap between consumer expectations and reality, it underscores the importance of transparency in healthcare practices. With increased awareness and advocacy, ASEM strives to empower patients to make informed choices about their health and medications.
To learn more about ASEM's mission and efforts, individuals can visit their official website at safeandeffectivemeds.org and connect with them on social media platforms like LinkedIn, X, Instagram, Facebook, and TikTok.
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