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Statement from Partnership for Safe Medicines on new litigation alleging illegal distribution of retatrutide
Partnership for Safe Medicines Executive Director Shabbir Imber Safdar released the following statement on the six lawsuits Eli Lilly filed today against businesses it accuses of illegally distributing unapproved copies of its investigational drug, retatrutide. Lilly is suing these defendants for illegal distribution of retatrutide including, in one case, a licensed 503A compounding pharmacy.
[...]Statement from Partnership for Safe Medicines on the appeals court’s decision in Gilead Sciences v. Meritain Health
The appeals court’s decision in Gilead Sciences v. Meritain Health is unambiguous: you cannot import untraceable medicine with foreign-language labels, hand it to American patients, and call it equivalent to an FDA-approved medicine. Track-and-trace is a cornerstone of why the U.S. drug supply chain is the safest in the world, and it is not optional.
[...]Key takeaways from PSM’s Axios event: Examining risk and regulation in the compounded GLP-1 landscape
SAFE Drugs Act sponsor Rep. Rudy Yakym (R-IN), Rep. Nikki Budzinski (D-IL), leading obesity medicine specialist Dr. Scott Kahan, and PSM Executive Director Shabbir Imber Safdar. delivered a clear message: Compounded substances are not the same as FDA-approved medications, and treating them as such undermines patients’ safety.
[...]Plea Agreement, USA v Bryce Cleveland
United States District Court Western District of Virginia USA v Bryce Cleveland Plea Agreement Filed July 2026 Read the document.
[...]PSM joins PSI, Rx360 and PDSA in letter urging FDA to protect the traceable drug supply
PSM joined three other organizations for a sign-on letter explaining our concerns that unrestricted mass compounding increases the untraceable drug supply. An explosion of 503B compounding of these three substances, semaglutide, tirzepatide, and liraglutide, would dramatically increase the compounded medicine supply which is not serialized, and therefore, not traceable.
[...]PSM submits comment supporting the continued exclusion of GLP-1s from the 503B Bulks List
PSM supports the FDA’s proposal, which will help protect patient safety and the integrity of the drug approval process.
[...]Live event on safety on compounded GLP-1s
Join us in person in Washington DC on Wednesday July 26, 2026 for Axios Live “Examining Risk and Regulation in the GLP-1 Landscape” Speakers include The Honorable Nikki Budzinski (IL-13), Scott Kahan, M.D., M.P.H., F.T.O.S., Shabbir Imber Safdar, CFE, The Honorable Rudy Yakym (IN-02)
[...]Partnership for Safe Medicines urges FDA advisory committee to reject compounding of unapproved peptides
On July 23-24, the FDA will evaluate seven peptides for custom pharmacy compounding. Citing a critical deficit in human safety data, widespread consumer confusion, and systemic supply chain vulnerabilities, PSM urges the committee to block mass compounding and protect patient safety.
[...]Joint statement on warning to pharmacists about diverted HIV medicines being sold on online pharmacy-to-pharmacy platforms
ADAP Advocacy and the Partnership for Safe Medicines (PSM) issued the following joint statement as a warning to pharmacists that all discounted HIV products bought from online, pharmacy-to-pharmacy (P2P) marketplaces fit the definition of suspect product under U.S. Food and Drug Administration (FDA) guidelines and the Drug Supply Chain Security Act.
[...]Pharmacists beware: Diverted HIV medicines are being sold on online pharmacy-to-pharmacy platforms
The Partnership for Safe Medicines and ADAP Advocacy are warning that discounted HIV products bought from online, pharmacy-to-pharmacy (P2P) marketplaces qualify as suspicious products under U.S. Food and Drug Administration guidelines and the Drug Supply Chain Security Act. Given the risks, we believe that it isn’t safe or cost-effective to purchase HIV products from these platforms.
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