NICE Outlines Appeals Process for Drug Determinations

Drugmakers appealing a final appraisal determination by the UK’s National Institute for Health and Clinical Excellence (NICE) will be allowed to use three basic arguments, including unfair action by the institute, a draft guidance says. The agency will only consider appeals on the grounds that it acted unfairly in accordance with its published procedures, that it formulated guidance that cannot be reasonably justified in light of submitted evidence or that it exceeded its powers as a public body, NICE says in the draft.
International Pharmaceutical Regulatory Monitor