House passes “21st Century Cures"

Senate not expected to develop its version until next year    

The House of Representatives passed the 21st Century Cures Act by a 344-77 vote on Friday, July 10, eighteen months after Energy and Commerce Chairman Fred Upton (R-MI) and his Democratic co-sponsor Diana DeGette (D-CO) began listening sessions and hearings to draft the National Institutes of Health (NIH) reauthorization and Food and Drug Administration (FDA) reform bill. During debate many lawmakers praised the “non-partisan” effort.

In addition to authorizing yearly increases in funding, that is, providing room for the NIH appropriation to grow, the bill would also authorize a five-year, $8.75 billion NIH Innovation Fund, with $1.75 billion per year in mandatory appropriations routed through the NIH Director. The Innovation Fund is said to be mandatory because the money would not come via the regular appropriations process, but would have a separate source of revenue. 

The bill tasks the Innovation Fund with various specific purposes including the development of a new Accelerating Advancement Program, research funding tied to a specific project or objectives, research funding for innovative scientists and early stage investigators, high-risk high-reward research, research funding for small businesses, and the NIH intramural program.

FDA would receive $550 million in new mandatory spending over the same period, although the agency has said the added responsibilities it would shoulder under the bill could cost nearly double that amount. See the Science Advocacy blog’s earlier story explaining how the bill would work.

The House rejected a controversial amendment introduced by Dave Brat (R-VA) by a vote of 141 to 281.  If enacted, the Brat amendment would have made the Cures Innovation Fund to support NIH and FDA discretionary, instead of mandatory. If made discretionary, the Cures Innovation Fund would potentially divert funding for other important discretionary health programs and activities.

Prior to the vote, President Obama released a Statement of Administration Policy saying in part: “While the Administration welcomes the additional support for biomedical research and innovation included in H.R. 6, the Administration has concerns about providing additional funding for the National Institutes of Health (NIH) and FDA without addressing sequestration more broadly.  Sequestration funding levels threaten not only NIH research, but also other investments in innovation.  They threaten health care access and quality, not only by underfunding biomedical research, but also by underfunding key public health and mental health programs.  The President has proposed a plan to reverse sequestration and increase funding for NIH by $1 billion in Fiscal Year 2016 while making other pro-growth investments.  Separately, the new responsibilities for FDA outlined in H.R. 6 exceed the resources provided in the bill and the President’s FY 2016 Budget and as such, FDA will be unable to fully implement the programs established in the bill, while maintaining its current performance levels.” 

Although a number of scientific and patient organizations endorsed the 21st Century Cures Act, the American Psychological Association (APA) chose not to, citing concerns similar to those of the White House.  Howard Kurtzman, acting executive director of APA’s Science Directorate, said, “We agree with the Administration’s statement that NIH needs stable, secure funding provided by a budget agreement that does not force Congress to raid unrelated pots of money.  APA has worked hard with our coalition partners to improve research funding. But these NIH funds come with lots of strings attached: the House committee directs NIH how to spend almost every new dollar, and that may have the effect of narrowing NIH’s focus toward fewer diseases and lines of research.”

APA is one of the organizations that cosigned a letter to the Senate Health Education Labor and Pensions Committee that explains elements that should be present in the Senate version of the “Cures” legislation. The organizations suggest that legislation should support sustained increases in NIH appropriations; reaffirm, rather than narrow, NIH’s existing mandate to support interdisciplinary science and the full spectrum of scientific disciplines; and address several administrative and regulatory burdens that make the conduct of science more difficult and costly. The House will now wait to see if its decisive vote will encourage the Senate to move more quickly with its similar biomedical reform effort, known as Healthier Americans. So far, the upper chamber has indicated it has no plans to meet Upton’s timeline of getting a bill to the president’s desk this year and likely won’t have a bill ready for a floor vote until 2016.