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
Health Canada wants to stop letting drug companies appeal when their request for a fast-track review gets rejected. Right now, if a company asks for priority review of a new drug and gets turned down, they can ask Health Canada to reconsider. This proposal would eliminate that second chance.
Why This Matters
This is mostly inside baseball for the pharmaceutical industry. But it could affect how quickly new treatments reach Canadian patients. If drug companies can't appeal fast-track rejections, some promising drugs might take longer to get approved. On the flip side, it could free up Health Canada resources to review more drugs overall.
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 would make final decisions on fast-track eligibility with no appeal process.
Key Issues
- Should drug companies be able to appeal when their fast-track review request is rejected?
- What impact would removing the reconsideration process have on drug approval timelines?
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 by the deadline.