Manufacturers might be incentivized to speed up completion of confirmatory trials for their accelerated approval drugs if they are restricted from using a brand name until the drug is granted full regulatory approval by the US Food and Drug Administration (FDA), according to a recent Viewpoint article published in JAMA Health Forum.
“Under current regulations, manufacturers can begin marketing a product once it receives accelerated approval, even if its safety and efficacy have not been verified,” Catherine S. Hwang, of Oregon Health and Science University, and S. Sean Tu, of the West Virginia University College of Law, wrote in their paper. “From a business perspective, manufacturers lack sufficient incentives to complete these confirmatory trials.”…
