January 28, 2015

Long-Awaited 21st Century Cures Draft Released — What Does the Path Forward Look Like?

The U.S. House Energy & Commerce Committee on January 27, 2015, released its much-anticipated 21st Century Cures discussion draft. The nearly 400-page bill includes more than 100 provisions across five titles and focuses significantly on reforms intended to accelerate the pace of developing medical breakthroughs and delivering them to patients.

The package follows about nine months of foundational work conducted by the committee since last spring, work that included numerous hearings, roundtables and regional forums focused on an array of issues in the space. While the 21st Century Cures effort has been led by Committee Chairman Fred Upton and Rep. Diana DeGette, a senior Democrat, DeGette did not endorse the draft itself but did express a commitment to continue advancing what has been a largely bipartisan effort forward.

FDA

Provisions include those intended to further enhance the role of the patient in the drug development and FDA review process and to provide clearer FDA guidance on a number of drug development and related issues. A lack of clarity from the agency is often cited by industry and patient groups as being an impediment to drug development efforts.

The bill includes a policy proposal that would develop a pathway and process by which the FDA would review and, ultimately, qualify biomarkers for use in clinical trials as well as one that intends to promote greater use of centralized or similar types of Institutional Review Boards (IRBs) with the intent being to streamline and shorten the clinical research process.

The discussion draft also includes provisions that would provide additional incentives for companies to develop therapies in challenging areas such as rare diseases and conditions that require lengthy clinical trials.

NIH

The draft contains a number of elements focused on research and the National Institutes of Health. These include requirements for NIH to develop a strategic plan with priority focus areas and to place greater emphasis on high-risk and high-reward research. The bill includes proposals to fund the BRAIN research initiative as well as the NIH Common Fund which is intended to support research projects involving multiple research institutes. And, one provision would permit the National Center for Advancing Translational Sciences (NCATS) to engage in more late-stage research, a once-controversial domain as critics are concerned that NCATS might step into a role typically left to the private sector.

And, in what is sure to get a lot of attention on the NIH campus, the discussion document includes a proposal to establish four-year terms for institute and center directors and to empower the Director of the NIH to remove any institute and center director at any point during the term.

The Path Forward

While an early-stage action, the release of the discussion draft is significant in that it begins the necessary process of making the Cures initiative more concrete. Many of the provisions are not a surprise as they have been in the works for years or have been raised in one or more hearings or other events, but others will be more controversial.

Chairman Upton has laid out an aggressive path that would have the full House of Representatives approve the Cures bill by the Memorial Day holiday. Given the nature of the House and the sizeable Republican majority, this is possible, but support from Democrats will be needed to get traction in the Senate and to maintain a high-level of stakeholder support.

And while the bill does include some sections that would authorize more funding for various research efforts, it stops short of any NIH-wide funding proposal, an issue that is a high priority for many lawmakers.

In addition to gauging stakeholder reactions and reviewing various comments on what is included — or not included — in the draft, interested parties should keep a close eye on the upper chamber. U.S. Senate HELP Committee Chairman Lamar Alexander and top Democrat Patty Murray issued a statement on Tuesday expressing interest in working with the House on Cures-related priorities.

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