Let non-profits and academics add a cancer indication to an off-patent drug's label
Only the manufacturer can ask regulators to add a new use to a drug's label, and generic makers have no reason to. Universities and charities should be allowed to apply.
When a publicly funded trial proves an old drug works in cancer, the result rarely reaches the label because no marketing authorisation holder will file, leaving the indication off-label with weak reimbursement and guideline status. The EU's 2023 pharmaceutical reform proposal includes a mechanism for non-commercial entities to submit evidence for a new indication, which the regulator can then require all holders to include; the FDA has no equivalent. The proposal is a formal third-party supplement pathway in FDA, EMA and other regulators, with fee waivers, allowing academic sponsors to file, and a label change binding on all generic versions.
- No incentive to repurpose cheap drugs · Old, cheap drugs with anti-cancer signals never get the trials they need because no one profits from the result.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
Pages like this
not linked directly; found by shared links- IdeaA non-profit company to hold marketing authorisations for repurposed cancer drugs
Shares No incentive to repurpose cheap drugs, Regulatory divergence between regions.
- IdeaOpen-source dossier-building software for academic sponsors and generic makers
Shares No incentive to repurpose cheap drugs, Regulatory divergence between regions.
- IdeaA fast route to the matched drug when it is licensed for another cancer
Shares No incentive to repurpose cheap drugs, Regulatory divergence between regions.