Policy/Enforcement News
Final publication of guidelines for online pharmacy-to-pharmacy medicine marketplaces.
We’ve published the final document of best practices for online pharmacy-to-pharmacy marketplaces.
[...]What is a 503B outsourcing facility, and why are so many of them uninspected by FDA?
503B outsourcing facilities make our drug supply more resilient, but 81% of 503Bs newly registered since June 2021 have never been inspected by FDA staff. Learn why we recommend changes to this important program.
[...]Prescription Drug Affordability Board Activity, June 2025
Prescription Drug Affordability Board Activity, June 2025 Activities Summary Colorado: Colorado’s next PDAB meeting will be held on August 22, 2025. Maryland: Maryland’s PDAB met on June 23 for updates about federal drug pricing and Maryland’s biotech and life sciences industry. Oregon: At its June 18 meeting, Oregon’s PDAB reviewed survey data and narrowed its…
[...]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.
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