AB 1990
Patients Deserve Safer, Tested Medications
Across the country, widespread use of unapproved compounded weight-loss drugs is putting patients at risk. California can lead the way in strengthening oversight and protecting consumers.
AB 1990
Patients Deserve Safer, Tested Medications
Across the country, widespread use of unapproved compounded weight-loss drugs is putting patients at risk. California can lead the way in strengthening oversight and protecting consumers.
THE PROBLEM:
APIs in California's Compounded Weight-Loss Drugs Are Putting Patients at Risk
Over the last several years, an unprecedented surge of compounded weight-loss drugs has flooded the market, many made from illicit, inauthentic, or substandard active pharmaceutical ingredients (APIs).
Many of the ingredients used in these compounded drugs are sourced from overseas suppliers with questionable safety standards. Some of these facilities have never been registered with or inspected by the FDA. And many of the foreign-sourced ingredients contain harmful impurities that pose serious risks to patient health.
Bad actors are exploiting consumer demand by promoting these products through deceptive advertising that omits critical safety information. These misleading campaigns often appear in social media feeds, making it difficult for patients to distinguish between safe, approved treatments and potentially dangerous alternatives.
The Problem:
APIs in California's Compounded Weight-Loss Drugs Are Putting Patients at Risk
Over the last several years, an unprecedented surge of compounded weight-loss drugs has flooded the market, many made from illicit, inauthentic, or substandard active pharmaceutical ingredients (APIs).
Many of the ingredients used in these compounded drugs are sourced from overseas suppliers with questionable safety standards. Some of these facilities have never been registered with or inspected by the FDA. And many of the foreign-sourced ingredients contain harmful impurities that pose serious risks to patient health.
Bad actors are exploiting consumer demand by promoting these products through deceptive advertising that omits critical safety information. These misleading campaigns often appear in social media feeds, making it difficult for patients to distinguish between safe, approved treatments and potentially dangerous alternatives.
"We need the research. We are doing the largest, uncontrolled, unconsented human experiment of our time, playing around with these medications — whether it's in oral form, in compounding form, or giving them in microdosing, I don't think patients know that when they're signing up on these websites."
(on compounding of “semaglutide” products)
— Angela Fitch, MD, FACP, FOMA
Associate Director of MA General Hospital Weight Center
Former President of the Obesity Medicine Association
The Regulatory Gap
- Years of clinical trials and research
- Strict review for safety, quality, and efficacy
- Ongoing monitoring after approval
- Are not FDA-approved
- Do not undergo any premarket review before they reach patients
- Are not held to the same rigorous safety standards
California’s Solution: AB 1990
California has an opportunity to close these dangerous gaps and set a higher standard for patient safety.
What AB 1990 Does:
⇒ Protect patients from the use of poor-quality APIs in compounded weight-loss drugs
⇒ Ensure pharmaceutical-grade ingredients are used and sourced from FDA-registered and inspected facilities
⇒ Establish stronger quality assurance measures to detect harmful impurities
⇒ Require that advertisements for compounded medications are truthful and not misleading
By strengthening safeguards, AB 1990 helps protect patients from the risks of compounded weight-loss drugs.
What AB 1990 Does Not Do:
AB 1990 is carefully designed to protect patients without limiting access to weight-loss drugs.
It does not:
✘ Apply to any drugs other than compounded GLP-1 agonists or similar drugs approved for weight loss
✘ Apply to compounded drugs made from finished FDA-approved medications, including those commonly used in hospitals or clinical settings
✘ Apply new quality requirements to outsourcing facilities operating within federal law
✘ Interfere with a provider’s ability to prescribe compounded medications tailored to individual patient needs
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Patients deserve better.
Support safer medications in California.
Stronger safeguards, greater transparency, and higher standards will help ensure Californians are better protected from risks of unsafe drugs.
