BIO submitted comments to the Food and Drug Administration (FDA) on topics that may be considered by the Food and Drug Administration Combination Product Policy Council. BIO is generally supportive of the criteria listed to determine what topics the Council will consider. In addition to those criteria, BIO requests the Council develop recommendations for implementation of provisions introduced in the 21st Century Cures Act. BIO also requests more information about how the Council will address product-specific inter-Center disagreements during a product’s review cycle, as well as a common lexicon to be used across Centers.

BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, How to Prepare a Pre-Request for Designation (Pre-RFD). BIO supports continued improvements to the review process of combination products. BIO says the draft guidance promotes early dialogue between sponsors seeking approval of combination products and the FDA. BIO provides additional suggestions to help clarify the draft guidance.

BIO submitted comments on the Institute for Clinical and Economic Review (ICER)'s call for proposed improvements to its Value Assessment Framework. While some of the proposed revisions have the potential to make progress toward aligning the Framework with the principles of individualized patient care and holistic value assessment, ICER must provide additional details with regard to how these proposed revisions will be operationalized before stakeholders can assess whether the revisions will meaningfully address critical gaps in the Framework.

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on FDA’s Revised Draft Guidance for Industry Submission of Quality Metrics Data (Revised Draft Guidance).