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FDA Alert: Counterfeit Ozempic found in U.S. Supply Chain

April 15, 2025
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The FDA and Novo Nordisk are warning the public about counterfeit Ozempic injections circulating in the U.S. drug supply chain. The falsified products, labeled with lot number PAR0362 and serial numbers beginning with 51746517, were seized by the FDA on April 9, 2025. Their contents and safety are unverified and pose serious health risks.

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Prescription Drug Affordability Board Activity through March 31, 2025

April 15, 2025
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Prescription Drug Affordability Board Activity through March 31, 2025 Activities Summary Colorado: Colorado’s PDAB cancelled its March meetings. Maryland: Maryland’s PDAB met on March 24, 2025 to begin a cost review of Farxiga and review feedback about updates to PDAB regulations. Oregon: Board members met on March 19, 2025, where they elected a subset of drugs for affordability reviews. 31…

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New initiative: Best practices for online pharmacy-to-pharmacy marketplaces

April 15, 2025
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PSM is seeking input on developing a set of best practices to reduce sales of counterfeit and diverted medicines on online pharmacy-to-pharmacy marketplaces.

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Boxes showing the lot and serial number of counterfeit Ozempic

April 14, 2025: Regulators announce a third instance of counterfeit Ozempic injections in the U.S. drug supply

April 14, 2025
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The FDA announced that it had seized counterfeit Ozempic injections on April 9. PSM testified at a congressional hearing.

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April 7, 2025: A study examines FDA-OCI’s enforcement actions over a five-year period

April 7, 2025
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A study examined the 130 enforcement actions undertaken by the U.S. Food and Drug Administration’s Office of Criminal Investigations from 2016 through 2021.

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Colorado’s March 2025 Amended SIP Application

April 2, 2025
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The state of Colorado submitted a revised application to the U.S. Food and Drug Administration to operation a Canadian drug importation plan in March. This blog post examines how the state’s application has changed over the years.

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FOIA Returns from towns using Alternative Funding Vendors

April 1, 2025
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PSM has sent open records requests to several towns and schools with self-funded health plans about their relationships with Alternative Funding Vendors.

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Colorado Department of Regulatory Agencies updates Joint Budget Committee on litigation costs

April 1, 2025
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A March 12, 2025 memo said the state had paid more than $150,000 defending itself in a lawsuit Amgen had filed over plans to set an upper payment limit on its rheumatoid arthritis treatment, Enbrel.

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March 31, 2025: Senator asks how FDA will be accountable for unregulated active pharmaceutical ingredient (API) imports

March 31, 2025
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Senator Jim Banks asked pointed questions about how FDA will stem the tide of semaglutide and tirzepatide coming from unknown facilities.

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Handout: Illegal ingredients linked to knockoff weight loss drugs pouring in from foreign sources

March 26, 2025
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Compounded versions of GLP-1 injectable treatments for diabetes and obesity have surged in popularity despite a lack the safety and efficacy assurances. The FDA has warned that these knockoff versions sometimes contain illicit semaglutide or tirzepatide-the active pharmaceutical ingredients (APIs) in weight loss drugs. Working with George Karavetsos, former director of FDA’s Office of Criminal Investigations and a federal prosecutor,…

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