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He just wanted to get back to work: a simple backache ended in tragedy
35-year-old Tyreek Lewis just wanted his back pain to stop, but pain relief would mean time off from work, hours of tests, and extra appointments. So he took what looked like a simple shortcut. It killed him, and altered his family’s life forever.
[...]Plea Agreement, USA v Jon Paul Dadaian
United States District Court District of New Jersey USA v Jon Paul Dadaian Plea Agreement Filed May 2022 Read the document.
[...]Mass drug compounding risks
How does mass compounding threaten patients? Drug compounding is intended to meet individual patient needs or temporarily bridge shortages — but the GLP-1 market has broken that model. Today, telehealth companies and compounding entities are mass-producing and marketing unapproved compounded GLP-1s. These unapproved versions put patient health and informed decision-making at risk because they are…
[...]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)
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