Policy/Enforcement News
FDA announces changes to section 804 importation program proposals
A July 1, 2025 post clarifies that applicants can use “a static baseline approach for the cost-savings analysis” instead of trying to account for changes in unpredictable markets.
[...]Prescription Drug Affordability Board Activity, May 2025
Prescription Drug Affordability Board Activity, May 2025 Activities Summary Colorado: Colorado’s PDAB met on May 23 to approve the Data Submission Guide and begin rulemaking around an upper payment limit for Enbrel. Oregon: At its May 21 meeting Oregon’s PDAB discussed the timeline and process for affordability reviews and approved the generic drug report. One…
[...]Prescription Drug Affordability Board Activity, April 17 – April 30, 2025
Prescription Drug Affordability Board Activity, April 17 – April 30, 2025 Activities Summary Colorado: Colorado’s PDAB updated the Colorado Prescription Drug Affordability Advisory Council on its progress on April 24, 2025. Conversation focused on gathering stakeholder feedback. Maryland: Maryland’s Prescription Drug Affordability Advisory Council met on April 28,2025 to hear an expert presentation about Drug…
[...]Prescription Drug Affordability Board Activity through April 16, 2025
Prescription Drug Affordability Board Activity through April 16, 2025 Activities Summary Colorado: Colorado’s PDAB met on April 11, 2025, where it addressed an error in All-Payer Claims Database data and how it affected affordability review information for Enbrel, Cosentyx and Stelara. Maryland: Maryland’s PDAB did not meet in April. Oregon: Oregon’s PDAB met on April…
[...]Prescription Drug Affordability Board Activity through March 31, 2025
Prescription Drug Affordability Board Activity through March 31, 2025 Activities Summary Colorado: Colorado’s PDAB cancelled its March meetings. Maryland: Maryland’s PDAB met on March 24, 2025 to begin a cost review of Farxiga and review feedback about updates to PDAB regulations. Oregon: Board members met on March 19, 2025, where they elected a subset of…
[...]Colorado Department of Regulatory Agencies updates Joint Budget Committee on litigation costs
A March 12, 2025 memo said the state had paid more than $150,000 defending itself in a lawsuit Amgen had filed over plans to set an upper payment limit on its rheumatoid arthritis treatment, Enbrel.
[...]Prescription Drug Affordability Boards by the numbers
Prescription Drug Affordability Boards are an expensive idea that has not produced results. It’s time to move on.
[...]Handout: What is an Alternative Funding Program?
Some employers are hiring consultants, sometimes called “Alternative Funding Program (AFP) vendors” or
“importation program vendors,” to supply employees and their families with illegally imported and unsafe
medicines.
Prescription Drug Affordability Board Activity through February 25, 2025
Prescription Drug Affordability Board Activity through February 25, 2025 Activities Summary Colorado: Colorado’s PDAB did not meet in February. The next PDAB meeting will be March 7, 2025. Maryland: Maryland’s PDAB did not meet in February. The Board may have ad hoc meetings before its next scheduled meeting on March 24, 2025. Oregon: Board members…
[...]Prescription Drug Affordability Board Activity through January 27, 2025
Prescription Drug Affordability Board Activity through January 27, 2025 Activities Summary Colorado: On January 17th, the PDAB reviewed Draft Upper Payment Limit Data Submission Guidance to discuss whether it was sufficient to begin an upper payment limit review on Enbrel at the March 7th meeting. A January 23rd meeting of Colorado’s PDAAC involved reviewing the…
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