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NAEVR Supports Latest Version of 21st Century Cures Act Legislation That Reauthorizes NIH, Creates a New Innovation Fund

Legislative Update
November 29, 2016

Update
On December 7, the Senate passed the 21st Century Cures Act by a vote of 94-5, clearing the measure for the President, who is expected to sign the bill.

Update
On November 30, the House of Representatives passed H.R. 34 (which has become the new bill number for the 21st Century Cures Act) by a vote of 392-26, amended by a Manager’s Amendment submitted by House Energy and Commerce Chair Fred Upton (R-Mich.). While the Manager’s Amendment modifies slightly the allocation of funding in the NIH Innovation Account on an annual basis, it maintains the overall level of funding in the Account at a total of $4.796 billion between FYs 2017 and 2026. For the Precision Medicine Initiative, the Amendment provides $1.455 billion between FYs 2017 and 2026; for BRAIN, $1.511 billion between FYs 2017 and 2026; for cancer research, $1.8 billion between FYs 2017 and 2023; and for clinical research to advance regenerative medicine using adult stem cells, the Amendment provides $30 million between FYs 2017 and 2020.

Background
On July 10, 2015, and by a vote of 344-77, the House of Representatives passed H.R. 6, the 21st Century Cures Act, sending it to the Senate for consideration. This legislation, developed by the House Energy & Commerce (E&C) Committee, provided $8.75 billion over five years in mandatory funding for the National Institutes of Health (NIH) through the creation of a new Innovation Fund and increased the authorization levels for the NIH by $1.5 billion per-year for the next three fiscal years. NAEVR supported this bill.

A new version of the 21st Century Cures Act legislation was released on November 26 and reflects provisions from the prior-passed House version and from the package of “Innovation” bills that the Senate Health, Education, Labor, and Pensions (HELP) Committee passed earlier this year. It also includes language reflecting prior free-standing bills, such as funding for grants to states focused on responding to the opioid addiction crisis, provisions to strengthen the nation’s mental health care system, and a number of changes to Medicare policy that are reported to be bipartisan in nature.

The bill is being queued up for House floor consideration on Wednesday, November 30, and is then expected to be taken up by the Senate next week. If passed, President Obama is expected to sign it into law shortly, as the White House has signaled its support.

Content
The bill provides $4.8 billion for NIH and $500 million for the Food and Drug Administration (FDA) over a ten-year period (Fiscal Years 2017-2026). The NIH funding is in the form of a new Innovation Fund Trust to support a number of large-scale initiatives as follows: $1.5 billion for the Precision Medicine Initiative, $1.5 billion for the BRAIN Initiative, $1.8 billion for the Cancer Moonshot, and $30 million for an NIH/FDA joint initiative on regenerative therapies using adult stem cells. While the funding is fully paid for, the Appropriators would still need to sign off each year in order for it to be released. The offsets to cover the cost include proceeds from selling off part of the Strategic Petroleum Reserve and dollars redirected from future increases in the Prevention and Public Health Fund.

The NIH is re-authorized for Fiscal Years 2018-2020 (it was last reauthorized in 2006 for three years) with authorized funding as follows: FY 2018: $34.8 billion; FY 2019: $35.6 billion; FY2020: $36.5 billion. Note the following:

  • These levels are less than the $1.5 billion annual increases in the original bill.
  • Despite these increases being authorized, the Appropriators do not have to follow these amounts, especially since they need to operate within budget caps and bill allocations.
  • If NIH’s large-scale initiatives are funded by the Innovation Trust Fund and the Appropriators increase NIH funding, this could result in a larger percent increase in funding for the Institutes and Centers, such as the National Eye Institute (NEI).
The bill also includes a new "Next Generation of Researchers Initiative" managed out of the NIH Director’s office. Although this is not specifically funded, it could result in more grant award opportunities for early-stage investigators and reduce the age of first-time awardees. It also improves the loan repayment program.

NAEVR Comments
On November 29, NAEVR sent a letter to House E&C Chair Fred Upton (R-MI) and House leadership supporting the expanded H.R. 6, which read in part:

“Since vision loss is co-morbid with numerous diseases and conditions, we strongly support the NIH Innovation Fund as a means to support life-saving and life-enhancing research through these large-scale, NIH-wide initiatives—in addition to that being conducted by the NEI. NAEVR is pleased that the Act’s Innovation Fund enhances, not replaces, a strong investment in NIH through the regular appropriations process.”
In its letter, NAEVR also supported the three-year NIH reauthorization and increased authorized funding levels since “they send a strong message to the Appropriators,” as well as the new initiatives regarding emerging scientists.

On December 2, NAEVR sent a similar letter to Senate Health, Education, Labor and Pensions (HELP) Committee Chair Lamar Alexander (R-TN) expressing support for Senate action to pass the legislation.

Click here to access the E&C Committee’s Press Release and a Section-by-Section summary of the bill.