21st Century Cures Draft Legislation Aims to Accelerate New Therapies

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Building upon nearly a year of hearings, roundtables, and input from patient and other advocacy groups, the House Energy and Commerce Committee released a draft piece of legislation aimed at spurring the development of innovative new therapies and speeding their delivery to patients. Energy and Commerce Committee Chair Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) launched this bipartisan effort—the 21st Century Cures Initiative—during the last Congress, and the committee floated a preliminary draft bill in January 2015.

ASN has been in conversation with committee staff and the offices heading up components of the draft legislation of potential relevance or benefit to patients with kidney disease—such as telehealth expansion in the Medicare program and the development of patient-reported outcomes measures for use in US Food and Drug Administration regulatory decision-making; the society’s input on the discussion draft is available at https://www.asn-online.org/policy/.

The nearly 400-page draft is chock-full of proposals—some new, some based on prior legislation—as well as a significant number of “placeholders” that will be fleshed out in the coming weeks and months. Broken down into five broad sections, the draft currently covers the following themes:

  • TITLE I—Putting Patients First By Incorporating Their Perspectives into the Regulatory Process and Addressing Unmet Needs

  • TITLE II—Building the Foundation for 21st Century Medicine, Including Helping Young Scientists

  • TITLE III—Modernizing Clinical Trials

  • TITLE IV—Accelerating The Discovery, Development, and Delivery Cycle and Continuing 21st Century Innovation at NIH, FDA, CDC, and CMS

  • TITLE V—Modernizing Medical Product Regulation

Despite the unobjectionable-sounding nature of these titles, the path to passage of the 21st Century Cures legislation will not be without controversy. Although the initiative began as a fully bipartisan effort, the January 2015 draft reflected considerably more partisan influence.

“As Chairman Upton and I begin to draft the bill itself, we look forward to receiving feedback on the issues identified in his draft document and other suggestions. While I don’t endorse the draft document, I know that with continued engagement, we can reach a bipartisan consensus to help advance biomedical research and cures,” said Rep. DeGette in a press release following the draft’s release.

Meanwhile, Senate Health, Education, Labor, and Pensions Committee Chair Lamar Alexander (R-TN) and Sen. Richard Burr (R-NC) chimed in to the conversation on discovery and development with the release in late January of the “Innovation for Healthier Americans” Report, a similar concept to the 21st Century Cures Initiative. “Getting more and better cures and treatments to patients more quickly is a goal shared by all,” Rep.Upton said. “I applaud Senators Alexander and Burr for releasing this report today and encouraging further discussion to determine how best to keep America at the forefront of health care innovation.”

Although some in Washington have pointed out that the 21st Century Cures draft includes numerous and potentially questionable benefits for industry, it has also won praise for many patient-centered provisions and for its focus on integrating the patient voice into the regulatory process. “Keeping our work centered on the patient and understanding the patient perspective will bring much needed focus on results for patients who may lack adequate treatment options,” said Energy and Commerce Committee Health Subcommittee Chair Rep. Joe Pitts (R-PA). Besides discussions regarding the policy content, the cost of the legislation could be an issue for the budget-conscious on both sides of the aisle—and as of yet, no estimates of the cost of the draft legislation have been released.

The committee anticipates an aggressive schedule to introduce the 21st Century Cures legislation and send a bill to President Obama’s desk for signature by the end of 2015, thereby avoiding the snarl of 2016 presidential election politics to the extent possible. Although the draft is far from finalized and its future remains uncertain, the initial target for having the bill on the House floor may be as early as May 2015. ASN will continue working with Congress to provide input and help advance a patient-centered bill. Stay tuned for email notices regarding how you can help the society encourage Congress to move this and other important legislation forward in the coming months.