The 393-page draft includes a range of provisions that would reshape development of medical treatments and cures and provide increased consumer access to important information about the health care they receive.
Avalere previously highlighted the following major policy areas as priorities:
- Regulatory Fixes and Funding;
- Development Incentives;
- Post-Market Evidence;
- Innovative Data Collection; and
- Patient Focus.
Upon initial review of the discussion draft, Avalere notes two sets of provisions that are notable for their potential impact. First, the bill allows for communication of benefit/risk information through the internet, ensuring greater consumer access. The bill includes a placeholder entitled, “facilitating responsible communication of scientific and medical developments.” This provision could be drafted to allow for greater communication of scientific evidence to medical providers and health plans. If enacted, this could create new opportunities for product value discussions across the health care system.
Avalere also notes that the bill proposes to expand the Food and Drug Administration’s Patient-Focused Drug Development initiative, including through greater use of patient reported outcomes as part of the FDA review process. These provisions could be notable in advancing greater patient engagement throughout a product’s life.