National Center for Health Research’s Public Comment on Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The National Center for Health Research is a nonprofit research center staffed by scientists, medical professionals, and health experts focused on research, policies, and programs that affect public health. Our Center analyzes scientific and medical data and provides objective health information to patients, providers, and policymakers. We do not accept funding from companies that make medical products, so we have no conflicts of interest.
Rabies exposure is not common in the U.S., and the available treatments are very effective. Nevertheless, monoclonal antibodies could be a beneficial addition to the treatment options. We support FDA’s efforts to look at the issues surrounding research on monoclonal antibodies to demonstrate safety and efficacy and to provide guidance for product developers. This may help ensure that they more quickly meet FDA’s standards for approval, with clear evidence that they will provide a beneficial treatment option for patients.
FDA’s approach for the types of evidence needed and suggested clinical trial design seem reasonable to provide adequate evidence for efficacy and safety. There are complications to designing and running large, well-designed, randomized controlled trials for these products. But it is important that pivotal trials for a monoclonal antibody product include enough patients, enough patient diversity, and a comparison group, which should help to reduce ambiguity around its effects.
In light of the current availability of effective treatment, it is especially important for the efficacy and safety to be clearly demonstrated in order to merit approval. Approval of a new rabies treatment with uncertain safety and effectiveness could harm patients.
Thank you for considering our views.
NCHR can be reached through Stephanie Fox-Rawlings, PhD, at email@example.com.