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FDA Cracks Down on Compounded Ozempic and Wegovy as Medicare Savings, Side Effects, and Affordability Concerns Mount

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Updated May 24, 2025, 04:57 PM

The U.S. Food and Drug Administration (FDA) has announced a crackdown on outsourcing facilities that manufacture or distribute compounded alternatives to brand-name weight-loss drugs Ozempic and Wegovy, effective from May 22, 2025. These drugs belong to the class of glucagon-like peptide 1 receptor agonists (GLP-1 RAs), originally developed for diabetes and weight management but increasingly used off-label for weight loss. While GLP-1 treatments have been found to improve quality of life without raising psychiatric risks in patients without mental illness, new concerns have emerged regarding side effects such as extreme fatigue, bone loss, and abdominal pain, highlighting the need for ongoing patient management.

The crackdown on compounded versions has led to challenges for U.S. patients, as discounts on weight-loss drugs have not sufficiently alleviated affordability issues. Medicare currently does not cover GLP-1 drugs, though estimates suggest it could save up to $245 billion annually if it did. In response, some direct-to-consumer programs like LillyDirect and Ro are helping patients access these medications despite regulatory and cost barriers. The growing demand for GLP-1 weight-loss medications in the U.S. has intensified scrutiny over their high prices and the structural factors contributing to these costs.

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Sources

foxbaltimore.com anh-usa.org medscape.com forbes.com

FOX Baltimore

@FOXBaltimore

As demand for GLP-1 weight-loss medications continues to grow in the U.S., so do questions about their affordability and the structural forces driving their sky-high prices.

Stephanie Seneff

@stephanieseneff

"While it’s clear that many are experiencing stunning and rapid weight loss, it’s becoming ever more apparent that the side effects and potential risks associated with GLP-1 RA drugs are being downplayed."

Medscape

@Medscape

Newly recognized issues, including extreme fatigue with excessive weight reduction, bone loss, and abdominal pain, point to the need for ongoing management of patients on GLP-1s, an obesity expert says.

Story Timeline

2 months ago•Latest version

FDA Cracks Down on Compounded Ozempic and Wegovy as Medicare Savings, Side Effects, and Affordability Concerns Mount

2 months ago•Original version

FDA Enforces May 22 Ban on Compounded Ozempic and Wegovy, Impacting GLP-1 Supply; Novo Nordisk, Eli Lilly, Discounts, Trump Involved

FDA Cracks Down on Compounded Ozempic and Wegovy as Medicare Savings, Side Effects, and Affordability Concerns Mount

Financial Analysis

Associated Financial Markets

Related Prediction Markets

Trump signs bill cutting Medicare before July?

How much spending will DOGE cut in first 6 months?

Sources

Story Timeline

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