Weekly Policy Update: CBSA Virtual Roundtable with Congresswoman Diana DeGette

This week CBSA held a virtual roundtable with Congresswoman Diana DeGette, who represents Colorado’s first Congressional district. It was a great opportunity to showcase the critical health innovations being developed and delivered by our ecosystem and to provide meaningful feedback on policy ideas that aim to modernize the delivery of new treatments for patients globally.

In her remarks, Congresswoman DeGette discussed her recent efforts to gather stakeholder input for 21st Century Cures 2.0, new legislation that would build on successes of the 21st Century Cures Act signed into law in 2016. The second iteration of the legislation will explore ways to safely and efficiently modernize the delivery of treatments to patients. Earlier this year, Congresswoman DeGette and Congressman Fred Upton (MI-06) released a concept paper outlining the six key issue areas they hope to address through Cures 2.0, many of which are priorities for CBSA and our members.

Congresswoman DeGette also spoke about her work on the VALID Act, which would establish a new regulatory framework at the FDA for all diagnostic tests, including in vitro diagnostics and laboratory developed tests. The legislation is a focus for CBSA and our members, and we will continue to engage with her office to ensure there is consistency, transparency, and flexibility in any new regulatory framework. 

Following the Congresswoman’s remarks, CBSA members provided updates on the work they are doing and highlighted specific policy issues or challenges impacting their company and the patients they serve.

Topics included:

  • Pandemic response priorities and the need for rapid, accurate COVID-19 point of care testing
  • Incentivizing development + commercialization of new antimicrobial products
  • Addressing critical areas of the supply chain
  • Ensuring patients have access to the treatments they need during the pandemic, through policies like hospitals without walls and home administration of Part B therapies
  • Modernizing coverage + reimbursement for new, innovative medical technologies that often face a significant delay in coverage after receiving FDA approval
  • The impact of coverage delays on small companies

Congresswoman DeGette told the group that she sees the life sciences community as an important partner in her efforts to modernize the development and delivery of new treatments. She looks to companies in our ecosystem to provide feedback on legislation and help her office understand the real-life impact of the policies being proposed.

CBSA appreciates the Congresswoman’s leadership and support of our life sciences ecosystem. We look forward to continuing our work with her office as she advances critical legislation to modernize the development and delivery of life-changing innovations for patients.

Categories: CBSA News