Policy/Enforcement News
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.
[...]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.
[...]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.
[...]Peptide therapies — popular, unproven, dangerous
Americans have become accustomed to taking peptides for for improved health, but unless they’ve undergone clinical trials and received FDA approval, there’s no way to establish a peptide’s safety or effectiveness.
[...]Partnership for Safe Medicines statement on FDA authorization of Colorado’s Section 804 Importation Program
“Colorado is now poised to repeat Florida’s failed attempt to implement Canadian drug importation,” said PSM Executive Director Shabbir Imber Safdar. “Since beginning their program in 2019, Florida has spent $132 million and still not imported a single unit of medicine, proving that these bulk importation programs are not reducing drug costs for Americans.”
[...]Prescription Drug Affordability Board Activity, April-May 2026
Prescription Drug Affordability Board Activity, April and May 2026 Activities Summary Maryland: In its April meeting, the Maryland PDAB set a UPL on Jardiance. In its May meeting, the board set a UPL on Ozempic. Virginia: Virginia’s governor vetoed the highly anticipated bills that would have established a PDAB in her state. Colorado: The PDAB provided…
[...]Case overview: Gilead Sciences v Pain Relief Rx, et al (2026 — ) – ongoing
Gilead Sciences has filed a complaint against Pain Relief Rx and other companies that it alleges sold diverted medicines on pharmacy to pharmacy marketplaces.
[...]Partnership for Safe Medicines Applauds FDA Action to Curb Unsafe Compounding of GLP-1 Medications
The Partnership for Safe Medicines strongly supports the Food and Drug Administration’s proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list. This action reflects sound science, sound law, and a clear-eyed commitment to patient safety. Full statement inside.
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