FDA’s draft guidance on biomarker qualification provides welcome codification of the regulatory path. But the amount of data required may remain beyond the reach of most companies, strengthening the importance of consortia.
The guidance, issued Dec. 10, outlines the process for obtaining approval of a biomarker for a specific preclinical or clinical purpose, and applies to biomarkers intended for making decisions about safety or efficacy.
The document formalizes a framework driven by the Foundation for the National Institutes of Health (FNIH) that was developed with FDA, the Critical Path Institute, NIH and PhRMA and outlined in a 2016 white paper.
The guidance provides new information on the recommended components of a biomarker development program, and the type and level of evidence to support qualification. Specifically, it includes a more detailed description of acceptable data types, and suggests that in most cases prospective studies will not be needed.
The tools stand to benefit many companies, for example by creating efficiencies across an indication. But industry has had little appetite for developing biomarkers independently.