On January 29, Senators Lamar Alexander (R-TN), Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee, and Richard Burr (R-NC), released Innovation for Healthier Americans: Identifying Opportunities for Meaningful Reform to Our Nation’s Medical Product Discovery and Development. The report addresses challenges to getting safe treatments, devices, and cures to patients more quickly and effectively, looking specifically at the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).
According to the senators:
“Our goal is simple and ambitious – to work in a bipartisan way with members of the HELP Committee to align public policies to support accelerating medical innovation and patient access to medicines and medical technologies. Science has never held greater potential to improve the quality of life and outcomes for America’s patients. In order to fully realize this exciting potential, we must identify, candidly assess, and confront existing factors that may be stifling efforts to innovate.”
Feedback is sought on a number of topics, such as:
- New strategies for attracting talent and providing support;
- Creative new approaches to optimizing public and private financing of medical research;
- Effective public policies to facilitate the translation of basic research into the development of innovative products, including enhanced collaboration between public-sector, academic, and industry efforts;
- Modernized clinical trials and a more efficient and effective regulatory framework for medical products; and
- A digital infrastructure that appropriately acquires, aggregates and analyzes the broad spectrum of data emerging from patient-focused modern medicine and technologies.
The senators expect to incorporate this feedback into a bipartisan “legislative package” to address the challenges identified. Alexander and Burr state that they intend to share the comments with HELP Committee Ranking Member Patty Murray (D-WA) and the entire committee.
In addition, Alexander announced that he and Murray are beginning “a major initiative,” including a bipartisan working group and a series of hearings, to examine the time and cost currently involved with the drug and medical device discovery and development process, and how to better align public policies to support medical innovation.