FasterCures responds to 21st Century Cures discussion document

February 17, 2015


The important 21st Century Cures process continues moving ahead and on January 27, 2015, Representative Fred Upton, chairman of the U.S. House of Representatives Energy and Commerce Committee, released a 393-page discussion document outlining specific proposals that had been shared through the 21st Century Cures Initiative. A statement issued by the Committee described the document’s purpose as seeking “to continue the important dialogue of the past year, encouraging more discussion from patients, innovators, researchers, care givers, and other experts on thecommon goal of accelerating the pace of cures in the United States.”

Over the past three weeks, FasterCures staff members participated in more than two dozen meetings of various stakeholders to discuss the document and other legislative action, including the President’s budget proposal and Precision Medicine Initiative. We also reached out through our broad network of thought-leaders in patient organizations, industry, academic institutions, and healthcare organizations, including our senior fellows and members of our various advisory committees. We solicited input on the breadth of proposals put forward and how specific provisions might impact innovation and efficiency in the biomedical ecosystem.

In response to Chairman Upton’s invitation to share feedback with the Committee,FasterCures submitted a set of detailed written comments focused on areas where our perspective and content expertise might be most useful to the Committee. Our comments follow three general themes:

  • FasterCures appreciates the focus on patients and would like to ensure the inclusion of patient perspectives through all aspects of medical product development and regulatory decision-making
  • New statutory responsibilities outlined in the draft will need to be accompanied by new resources so that these proposals do not divert scarce resources from existing core responsibilities
  • Provisions of the discussion document create new commissions, advisory bodies, reports, studies, and guidance documents. We are concerned that some of these requirements may overlap or be duplicative of current efforts or existing documents.

We encourage you to share your comments on the discussion document with the Committee and with FasterCures. With numerous legislative initiatives getting under way, we believe the best solutions will come from open dialogue and collaborative action.


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