BIO submitted comments to the Food and Drug Administration (FDA) on Benefit-Risk Assessments in Drug Regulatory Decision-Making. The benefit-risk framework is an important advancement in FDA product regulation because it reflects and reinforces the fact the FDA review process is grounded in the assessment of both benefits and risks. The FDA’s introduction and implementation of the structured benefit-risk framework has improved the transparency and communication of FDA’s decisions on approvals of new therapies. The framework has also allowed the FDA to share important information with the public about what to expect from approved therapies. BIO supports FDA's continued efforts to evaluate and improve the clarity of the benefit-risk assessment process throughout the lifecycle of drug evaluation. While the FDA benefit-risk framework has provided increased transparency and communication, additional work is needed in order to improve the framework. BIP provides recommendations for areas to continue to enhance the FDA’s benefit-risk framework, including transparency and flexibility of benefit-risk assessment in complete response letters, consistent use of the framework across review divisions, and including patient perspectives.

BIO submitted comments in response to the Health and Human Services (HHS/the Agency) Draft Strategic Plan for Fiscal Years 2018-2022. BIO strongly supports HHS’ mission to enhance the health and well-being of Americans, by providing for effective health and human services and by fostering sound, sustained advances in the science of underlying medicine, public health, and social services; and the associated strategic planning process.

BIO submitted comments to the U.S. Pharmacopeial Convention (USP) Healthcare Quality and Safety Expert Committee (Expert Committee) in response to the second round of public comment on the USP Drug Classification System (USP DC), released September 25, 2017.In response to the USP DC, BIO offers comments consistent with our comprehensive comments on the draft Version 7.0 Medicare Model Guidelines (MMG) and comments on last year’s draft USP DC, both of which are included as appendices for the Expert Committee’s reference. Our comments, as follows, also correspond to the call for additional feedback on how to make the USP DC more user friendly as expressed on the open-mic web meeting.