Americans for Safe and Effective Medicines (ASEM) has been established as a national advocacy organization focused on safeguarding patients from the risks associated with illegal large-scale drug compounding, counterfeit medications, and deceptive marketing practices. The organization also aims to hold companies and individuals accountable for practices that may compromise patient safety. Its launch coincides with the release of its first national survey, which found that while 84% of consumers prefer GLP-1 medications that have received approval from the U.S. Food and Drug Administration (FDA), only 17% are aware that compounded GLP-1 products do not undergo FDA approval.
Compounded GLP-1 products continue to be widely promoted through telehealth providers, medical spas, online vendors, and other distribution channels. These marketing practices often fail to clearly distinguish FDA-approved medicines from compounded alternatives, leading many patients to mistakenly assume that all such products meet the same regulatory standards for safety, effectiveness, and quality.
Fred Mills, Chief Policy Officer at ASEM, stated that many patients are making treatment decisions without receiving complete information about the products they use. He noted that ASEM was created to address a marketplace where consumer misunderstanding has become commercially advantageous. According to Mills, pharmaceutical compounding was originally intended to address the unique needs of individual patients rather than serve as a large-scale commercial enterprise.
Survey Highlights: Consumer Expectations vs. Awareness
The organization's survey identified a substantial gap between consumer expectations and their understanding of compounded GLP-1 medications:
Compounded GLP-1 products continue to be widely promoted through telehealth providers, medical spas, online vendors, and other distribution channels. These marketing practices often fail to clearly distinguish FDA-approved medicines from compounded alternatives, leading many patients to mistakenly assume that all such products meet the same regulatory standards for safety, effectiveness, and quality.
Fred Mills, Chief Policy Officer at ASEM, stated that many patients are making treatment decisions without receiving complete information about the products they use. He noted that ASEM was created to address a marketplace where consumer misunderstanding has become commercially advantageous. According to Mills, pharmaceutical compounding was originally intended to address the unique needs of individual patients rather than serve as a large-scale commercial enterprise.
Survey Highlights: Consumer Expectations vs. Awareness
The organization's survey identified a substantial gap between consumer expectations and their understanding of compounded GLP-1 medications:
- Approximately 84% of respondents indicated that FDA approval, clinical evaluation, and independent expert review are important considerations when selecting a GLP-1 medication. Among individuals currently using GLP-1 therapies, this figure increases to nearly 90%.
- Most current GLP-1 users incorrectly believe that compounded GLP-1 products have FDA approval.
- About 82% of primary care physicians reported treating patients who were unaware that compounded medications are not approved by the FDA.
Report Highlights Risks Associated with Mass Compounding
In addition to the survey, ASEM released a report titled The Shortage is Over. The Risks Are Not: How Illegal Mass Compounding Is Undermining Patient Safety—And What Must Happen Next. The report argues that temporary compounding practices permitted during the GLP-1 drug shortage have expanded into a largely unregulated commercial market for compounded GLP-1 products. According to the report, these products are distributed outside many of the regulatory safeguards that apply to FDA-approved medicines.
Drawing on FDA inspection records, product recalls, warning letters, and state regulatory enforcement actions, the report concludes that patient safety is being compromised by several factors, including:
In addition to the survey, ASEM released a report titled The Shortage is Over. The Risks Are Not: How Illegal Mass Compounding Is Undermining Patient Safety—And What Must Happen Next. The report argues that temporary compounding practices permitted during the GLP-1 drug shortage have expanded into a largely unregulated commercial market for compounded GLP-1 products. According to the report, these products are distributed outside many of the regulatory safeguards that apply to FDA-approved medicines.
Drawing on FDA inspection records, product recalls, warning letters, and state regulatory enforcement actions, the report concludes that patient safety is being compromised by several factors, including:
- Marketing practices that blur the distinction between compounded products and FDA-approved medications, contributing to widespread consumer confusion.
- Large-scale commercial distribution of compounded products that are not required to meet the same regulatory standards as FDA-approved medicines.
- Ongoing concerns regarding product quality, sterility, and the sourcing of ingredients used in mass-compounded injectable medications.
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