Shifting the Paradigm on Breastfeeding to Build a Healthier Future for all Americans
Policymakers on both sides of the aisle agree that no baby should ever go hungry, as evidenced by the bipartisan passage of recent breastfeeding legislation and widely supported regulations. However, significant barriers remain.
To encourage greater adoption of generic drugs in clinical practice the FDA should implement a dedicated regulatory pathway for non-manufacturers to seek approval of new indications for repurposed generic drugs.
New solutions are needed to target diseases before they are life-threatening or debilitating, moving from retroactive sick-care towards preventative healthcare.
At least 40% of Medicare beneficiaries do not have a documented AHCD. In the absence of one, medical professionals may perform major and costly interventions unknowingly against a patient’s wishes.
AI has transformative potential in the public health space, but innovation driven primarily by the private sector today may be exacerbating existing disparities by training models.
The incoming administration must act to address bias in medical technology at the development, testing and regulation, and market-deployment and evaluation phases.
The incoming administration should work towards encouraging state health departments to develop clear and well-communicated data storage standards for newborn screening samples.
Improving public awareness of FDA Advisory Committees would improve public trust and deter misinformation related to the approval of medical products.
The absence of consistent voting privileges for patient representatives on Advisory Committees hinders representatives from providing an voice on behalf of the community they represent.
Internal disagreements present a growing concern about FDA leadership overruling the expert opinions of scientific staff and proceeding with official approvals, thus undermining staff expertise, decreasing agency morale, and potentially diminishing public trust.
AdComm members note a lack of transparency in recruitment methods, insufficient training, and limited understanding of regulatory procedures.
Public meetings led by FDA Advisory Committees are instrumental in facilitating transparent deliberation between the FDA, the advisory body, and the American public.