Policy/Enforcement News
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.
[...]Prescription Drug Affordability Board Activity, January 2026
Prescription Drug Affordability Board Activity, January 2026 Activities Summary Colorado: At its January meeting, the PDAB discussed ways to improve patient engagement and agreed to accept the dismissal of Amgen v. Mizner. The board’s next meeting will be February 20, 2026. Maryland: Maryland’s next PDAB meeting will be February 23, 2026 at 9:00 AM ET.…
[...]Update on drug importation, February 2026
Well-meaning advocates continue to propose importing medicine from foreign countries to lower drug prices for Americans. Past efforts didn’t pay off financially and raised public health risks. Here’s the state of this issue today.
[...]PSM gives testimony in opposition to a Colorado bill to permit alternative funding programs
On February 17, PSM submitted written and oral testimony in opposition to Colorado HB26-1056, which would permit self-insured employers to use alternative funding programs to import foreign medicines from outside the U.S. drug supply chain.
[...]Four things Congress should do for patient safety in the rest of the 119th
This post outlines practical steps Congress should take to strengthen pharmaceutical border security, reinforce regulatory oversight, and protect patients.
[...]Prescription Drug Affordability Board Activity, December 2025
Prescription Drug Affordability Board Activity, December 2025 Activities Summary Colorado: In October, Colorado’s PDAB heard testimony about its decision to set an upper payment limit on Enbrel, and set price of $600 per 50mg/1ml, effective January 1, 2027. The board’s next meeting is January 9, 2026. Maryland:The PDAB met on December 8, 2025 to review…
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