Drug Makers Need Safe Harbor For Patient-Focused Development, Advocates Say
This article was originally published in The Pink Sheet Daily
Biomedical reform legislation should include mechanism to encourage premarket patient engagement, National Health Council’s Marc Boutin says.
You may also be interested in...
Senate eyes a biomedical reform process that is simultaneously narrower and slower than the House’s 21st Century Cures Initiative; FDA’s Hamburg asks for ability to shape sponsor’s trial designs earlier and more regulatory science funding.
First Humira biosimilar launches raise worries about holes in US health system that may let the brand product continue to dominate. If Humira biosimilars can’t get a strong foothold, reform to biosimilar policy for medicines reimbursed through the pharmacy benefit may be necessary if the US wants to rely on these products to bring down the cost of brand biologics.
Marks appeared to use the variable EUA bar to justify what many viewed as early mistakes by FDA during COVID-19, and to emphasize the importance of physician awareness of the strength of evidence used to authorize a drug.