Washington, DC (August 3, 2017) - National Health Council Statement on Senate Passage of FDA User Fee Reauthorization and BENEFIT Act
The following statement is from NHC’s Chief Executive Officer, Marc Boutin:
We commend the Senate for passing the FDA Reauthorization Act (FDARA) in an overwhelmingly, bipartisan fashion. This transformative agreement is the culmination of more than a decade of work to elevate the voice of the patient and the promise of emerging science.
Passing this bill is a crucial step in reauthorizing four user fee programs that ensure the Food and Drug Administration (FDA) has the tools it needs to deliver safe and effective treatments and cures to people with chronic diseases and disabilities. The new user fee programs will also include many patient-supported improvements such as increasing the voice of the patient in product development, increasing transparency of biomarkers and surrogate endpoints, developing a process for using real-world evidence, and improving the rare disease program.
We were also pleased to see Senate passage of S. 1052, the Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act. This bill will ensure that patient perspective data is considered as part of the FDA’s benefit-risk assessment, further elevating the voice of the patient at the Agency.