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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.
Shares No incentive to repurpose cheap drugs, Regulatory divergence between regions.
Shares No incentive to repurpose cheap drugs, Regulatory divergence between regions.
Shares No incentive to repurpose cheap drugs, Regulatory divergence between regions.
Shares No incentive to repurpose cheap drugs, Regulatory divergence between regions.