Senate Democrats Seek NIH, FDA Mandatory Funding

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By Jeannie Baumann

March 4 — Senate Democrats pushing for a mandatory funding stream for the NIH and the FDA introduced a bill to provide both agencies a total of $5 billion per year.

The legislation would provide additional money to fund specific efforts such as the precision medicine and cancer moonshot initiatives. Democrats on a key Senate health committee introduced the bill (S. 2624) March 3, about one week before a medical innovation markup as part of the Senate's companion effort to the House's 21st Century Cures bill (H.R. 6).

However, the Democrats' bill isn't on the HELP Committee's list of measures set for consideration in the March 9 markup.

Sticking Point

The question of whether to include mandatory funding for the National Institutes of Health and the Food and Drug Administration in the medical innovation legislative package has been a major sticking point in an otherwise bipartisan effort to accelerate new medical treatments to patients. The House-passed bill included a mandatory funding stream for both the NIH and the FDA. Democrats on the Senate, Health, Education, Labor, and Pensions Committee have made clear in previous markups and hearings they won't support any medical innovation package that doesn't include additional funding for both agencies .

“Congress has neglected these critical investments for more than a decade,” Sen. Elizabeth Warren (D-Mass.) said in a March 3 statement. “Any package of innovation bills coming out of the HELP Committee must include significant increases in funding for NIH and FDA. Anything less is just lip service.”

$5 Billion Through 2025

The Senate bill would establish a Biomedical Innovation Fund that would provide $5 billion total to both agencies for the current 2016 fiscal year through FY 2025. By comparison, the House bill included a Cures Innovation Fund that provided $8.75 billion total ($1.75 billion per year) for the NIH and $550 million ($110 million per year) for the FDA for fiscal years 2016 through 2020 . A fact sheet on the bill reiterated that Senate Democrats want to supplement existing appropriations for both agencies instead of replacing the discretionary dollars with mandatory funding.

HELP's top Democrat, Sen. Patty Murray (D-Wash.), said in a March 3 statement that S. 2624 would give scientists and researchers the tools, resources and certainty critical to tackling some of the most pressing medical challenges. “There is bipartisan agreement on the need to boost investments in innovative medical research, so I hope that our colleagues on the other side of the aisle will join us to advance this legislation and offer hope to patients and families nationwide,” Murray said.

HELP Chairman Lamar Alexander (R-Tenn.), who has been leading the Senate's medical innovation initiative with Murray, has said that he wants the committee to approve the medical innovation package—a total of 45 to 50 measures over three mark-up sessions—and then work out the funding through a separate effort that would happen on the Senate floor. During the first markup in February, Alexander indicated he would support an innovation package through mandatory funding to pay for specific, temporary projects with an expiration date. But the HELP chairman said he didn't want to establish a permanent mandatory fund .

In addition to the precision medicine and the cancer moonshot initiatives, the bill would provide money for:

  • the Brain Research through Advancing Innovative Neurotechnologies initiative;
  • breakthrough research on diseases with unmet medical needs;
  • research on chronic, degenerative diseases that disproportionately contribute to health-care costs;
  • early career scientists;
  • improving diversity of the scientific workforce;
  • regulatory science; and
  • the development, regulatory review and postmarket surveillance of new medical products.
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    To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bna.com

    To contact the editor responsible for this story: Lee Barnes at lbarnes@bna.com

    For More Information

    The Senate Democrats' bill is available at https://www.congress.gov/bill/114th-congress/senate-bill/2624, and a fact sheet issued by the Senate HELP Democrats is available at http://www.warren.senate.gov/files/documents/National_Biomedical_Research_Act_Fact_Sheet.pdf.

    More information on the March 9 Senate HELP markup is available at http://www.help.senate.gov/hearings/s1878-s1077-s1101-s2055-s1767-s1597-s2512-and-nomination-of-dr-john-king.