Should Drug Companies Lose the Right to Appeal Fast-Track Review Rejections?
Official title: Consultation: Removal of reconsideration process from requests for priority review and advance consideration for Notice of Compliance with conditions
Why This Matters
This is mostly an industry concern, but it could affect how quickly new treatments reach Canadian patients. Fast-track reviews exist for drugs that treat serious conditions with no good alternatives. If companies can't appeal rejections, some might not bother applying—or promising drugs could face longer waits.
What Could Change
Drug companies would lose the ability to request reconsideration when denied Priority Review status or advance consideration for conditional approval. Health Canada says this would streamline their process. Companies would need to get their applications right the first time.
Key Issues
- Should drug companies be able to appeal when denied fast-track review status?
- Will removing the reconsideration process affect access to new treatments?
How to Participate
- Read the notice outlining Health Canada's proposal to understand the proposed changes.
- Send your feedback by email to brdd-cppic_brdd-cppci@hc-sc.gc.ca before the deadline.