Policy/Enforcement News
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.
[...]Prescription Drug Affordability Board Activity, February-March 2026
Prescription Drug Affordability Board Activity, February and March 2026 Activities Summary Colorado: The PDAB did not meet in February or March. The next meeting was held April 3, 2026. Maryland: At its February meeting, the PDAB introduced a new board member and approved UPL frameworks for Ozempic and Trulicity. In March, it heard a briefing…
[...]The FDA speaks up about AFPs and drug importation
Is personal drug importation legal in the context of alternative funding programs? The FDA says no.
Are self-funded health plans allowed to import medicine because of “Section 804” or “Florida’s importation plan”? Also, no.
[...]Using pharmacy-to-pharmacy marketplaces? Read this Suspicious Sales Surveillance Report
Online pharmacy-to-pharmacy marketplaces help with inventory management, but they also require vigilance because they carry a higher risk of being exploited by criminals selling black market medicines.
[...]Counterfeit drug crimes typically earn light sentences. How did Safe Chain’s co-owners, the Boyd brothers, end up with 18 and 20 years?
Wire fraud charges drove much higher penalties than the shipping of unsafe medicine into the supply chain, and the Boyds’ sentences were based on the government proving high-dollar, deliberate fraud.
[...]March Drug Importation Madness
For a pretty dead policy idea, bulk drug importation has had a lot of news lately. Get the update!
[...]Case overview: Novartis AG and Genentech v SHARx and Campbell Heights Pharmacy (2026 — ) – ongoing
Novartis and Genentech have filed a Lanham Act complaint against an alternative funding program and a Canadian pharmacy allegedly supplying Canadian Xolair to Michigan patients.
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