Themes from the 21st Century Cures Initiative

By Tiffany Kaszuba, Policy Associate

In April, House Energy & Commerce Committee Chairman Fred Upton (R-MI) and Representative Diana DeGette (D-CO) announced an initiative aimed at accelerating the development of new treatments and medical breakthroughs called “A Path to 21st Century Cures.”  Since the announcement, the bipartisan duo, along with other members of the House Energy & Commerce Committee, has held a series of roundtables both in Washington and across the country, welcoming input from various stakeholders.

Last week, the panel brought in some heavy hitters for their final roundtable, including HHS Secretary  Sylvia Burwell, FDA Commissioner  Margaret Hamburg and NIH Director Francis Collins. During the discussion, several themes emerged that could make their way into the legislation that the panel intends to introduce next year.  Here are some worth noting:

  1. Funding:  Throughout all of these roundtables, the major recurring theme has been the need for a sustained investment in biomedical research at the NIH. Dr. Collins went as far as to blame cuts for delaying the development of an Ebola vaccine. However, funding for the FDA was also called into question as it relates to the pace at which the agency is able to review and approve drugs. That said, Representative Joe Pitts (R-PA) squashed the hope of any additional funding being connected this initiative when he asked Dr. Collins where in the budget Congress should cut to provide more money for NIH. Ouch!
  2. Encouraging Young Scientists:  If you think funding for experienced researchers is hard to come by, it is even harder for junior researchers. It is no secret that young scientists, and potential young scientists, are leaving the lab to pursue more stable careers. A majority of the panel mentioned this issue in their remarks and offered suggestions for addressing it, including student loan forgiveness and matching programs with industry to award grants to young researchers.
  3. Collaboration:  Both Drs. Hamburg and Collins mentioned collaboration with stakeholders as critical to advancing their agencies’ missions.  At the FDA, Dr. Hamburg explained, collaboration between the agency, researchers, industry, and even patient advocates early in the drug development process can often expedite the approval of a drug. The NIH also finds benefits in collaborating with stakeholders to enable and encourage data sharing through initiatives such as the Accelerating Medicine Partnership.
  4. Patient Participation:  Many panelists called for measures to increase patient participation in both clinical trials and discussions surrounding drug development. They suggested addressing the 40-page consent form which often deters patients from entering clinical trials and creating a process to waive HIPPA requirements for patients who wish to share their medical information with researchers.
  5. FDA Turnover:  In some ways, this relates to funding, as many investigators are leaving FDA to pursue more competitive careers in industry. However, panelists from industry called for Congress to act to address the 25 percent turnover rate at FDA, which slows the approval process.
  6. Regulatory Burden:  Participants noted that in some cases, namely through overly-burdensome regulations and paperwork, Congress and the Administration have created some of the roadblocks to innovation.  At the same time, other regulations and paperwork ensure the safety of patients. Finding the balance between accelerating development and keeping patients safe should be one goal of any legislation that comes from these meetings.

While it remains to be seen what will be included in next year’s legislative proposal, public support and hope for 21st Century Cures is strong. Representatives Upton and DeGette are continuing to take public input and will begin work on a legislation discussion draft for release in early January 2015, with hopes of introducing legislation later in the year. 

Lisa Ellington

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