Canada’s Patented Medicine Prices Review Board (PMPRB) has adopted an amended interim guidance that includes a controversial pricing mechanism, but has said the guidance would only apply for “a brief period.” The PMPRB is planning to launch a consultation soon about new guidelines, which it said it would approach “with a fresh and open mind.”
Contentious Pricing Mechanism Adopted In Canada But Only For ‘A Brief Period’
Drug companies are unhappy about a new median price test and the exclusion of the Consumer Price Index in the amended interim guidance from the Patented Medicine Prices Review Board
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An initiative run by health technology appraisal (HTA) bodies in the US, Canada and England is looking at how non-traditional treatment benefits, such as the value of hope and scientific spillover, can inform appraisals and understanding of a product’s value.
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The Canadian regulator says its current policy on identifying and labeling drug products in “kits” is insufficient to address the diverse types of co-packaged drug products that are entering the market.
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Canada’s new guidance on rare disease registries is based on international guidelines, but in some areas there remains work to ensure that implementation of some recommendations is feasible in the Canadian context.
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As part of efforts to modernize its clinical trials framework, the Canadian regulator is looking to better facilitate expanded access clinical trials, which allow investigational drugs to reach patients with serious conditions before they are approved.
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Sector-specific tariffs, including on pharmaceuticals, could be announced as early as this week.
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Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.
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The former principal deputy commissioner said the “decapitation” of senior leadership will make resolving internal disputes more difficult, which will slow application reviews. Woodcock also called the FDA layoffs a slow-moving catastrophe.