NIH Budget Proposal Alarms Advocates

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President Obama’s proposed nearly $4.15 trillion budget for the 2017 federal fiscal year offers small increases for NIH and FDA, sets up a showdown over sources of NIH funding, and directs big dollars to research programs championed by the administration, in a spending plan unlikely to face smooth sailing in Congress.

Obama is seeking $33.1 billion in overall program level funding for NIH, up about $1 billion or 3% from the current fiscal year, during which the president and Congress agreed to a $2 billion spending hike for the agency.

But a $1.8 billion portion of NIH’s proposed budget would be “mandatory,” not subject to annual appropriations from Congress but based on dedicated sources of revenue.

The White House hopes Congress will find such a source; the House of Representatives envisioned a $550 “Cures Innovation Fund” for the FDA in the 21st Century Cures Act biomedical research funding bill that passed the chamber last year. But the fate of 21st Century Cures is uncertain. Senate Committee on Appropriations Chairman Thad Cochran (R-MS) said last month his chamber would only vote on bills containing portions of the measure, but not on 21st Century Cures itself.

Yesterday, Cochran issued a statement warning: “There will be little appetite in Congress for mandatory spending that diminishes fiscal discipline and congressional oversight,” while House Appropriations Chairman Hal Rogers (R-KY) dismissed Obama’s budget proposal as “a spending wish list that doesn’t reflect our real budgetary constraints and that would saddle hard-working Americans with additional taxes and fees.”

Most worrisome, say advocates of greater biomedical research funding, Obama’s proposed budget also calls for reducing the agency’s discretionary spending by $1 billion, affecting all 27 NIH institutes and centers.

“The bottom line for us is that the cut to NIH’s base budget in the fiscal year 2017 bill is extremely concerning, no question about it,” Jon Retzlaff, managing director of science policy and government affairs for the American Association for Cancer Research, told GEN yesterday. “It’s problematic to take money out of NIH’s base budget when we are so interested in making sure NIH receives sustained and predictable budget increases through the regular annual appropriations process.”

The American Society for Biochemistry and Molecular Biology (ASBMB) expressed disappointment: “Frankly, this budget does little to capitalize on the enormous bipartisan support for the NIH in Congress,” ASBMB Public Affairs Director Benjamin Corb said in a statement. “To propose a funding level that is unable to sustain the biomedical research enterprise is surprising given the president’s consistent, strong support for the agency.”

Jennifer Zeitzer, deputy director of the Office of Public Affairs for the Federation of American Societies for Experimental Biology (FASEB), told GEN that Congress’ timetable for resolving the budget will be complicated by politics and the calendar: Conservative members of Congress remain upset with last year’s budget deal that boosted NIH funding. The presidential and Congressional elections will shrink the timetable for action: Party conventions occur in July, followed by vacations in August, then fall re-election campaigns for all House members and one-third of the Senate.

Advocates for greater research funding, Zeitzer said, can take comfort in the support for NIH spending shown by some key subcommittee chairs in Congress, Sen. Roy Blunt (R-MO) and Rep. Tom Cole (R-OK).

“The one thing that we have as a community is there’s just a general level of enthusiasm and increased level of enthusiasm on Capitol Hill to continue to support NIH and expand what NIH can do with the dollars that it has, and really tackle some of those major health challenges,” Zeitzer said.


From Alzheimer’s to Zika

The proposed NIH budget would also continue raising spending for several efforts launched in recent years by Obama’s administration. The spending plan proposes $309 million for Obama’s precision medicine initiative, of which nearly all ($300 million) would go to NIH—up 55% from $193 million in FY2016. The extra funding is intended to go toward building a million-person voluntary national research cohort and continuing efforts by NIH’s National Cancer Institute to lead research on cancer genomics.

NIH’s parent agency, the U.S. Department of Health and Human Services, said in a summary of budget highlights that the cancer genomics effort is designed to help researchers “understand how the DNA from an individual cancer tumor can be used to predict the right choice of targeted therapies, how resistance to therapy can occur, and how to test new combinations of targeted cancer drugs.”

Of the remaining funds, the Office of the National Coordinator for Health Information Technology would receive $5 million to develop an interoperable and secure health data exchange system. The FDA would receive $4.4 million to establish the National Medical Device Evaluation System, designed to identify patients who benefit from specific types of devices, and to continue precisionFDA, a crowdsourced cloud-based platform meant to advance regulatory science around next-generation sequencing-based analytical tools and data.

Another initiative, Brain Research through Advancing Innovative Neurotechnologies (BRAIN), would see its funding raise $45 million, or 30%, to $195 million.

“In FY 2017, the increased funds will continue to support basic neuroscience research, human neuroscience, neuroimaging, and training initiatives, as well as potential projects to collaborate with industry to test novel devices in the human brain, new ways to address big data from the brain, and develop devices for mapping and tuning brain circuitry,” the HHS added.

NIH spending for Alzheimer’s disease research would also balloon under the budget proposal, to $910 million. These funds would be used for basic neuroscience research, studies to identify risk and protective genes, and more than 35 clinical trials to test preventive treatments and new therapies.

Obama’s proposed spending plan includes a handful of big-dollar proposals intended to fund research priorities trumpeted by the administration in recent weeks.

As disclosed by the White House last week, the president is seeking to spend $755 million for the new national effort, the “moonshot,” aimed at developing cures for cancer. Most of the funds ($680 million) would go to NIH, with the FDA receiving the remaining $75 million. The FDA’s funds would go toward a new virtual Oncology Center of Excellence intended to speed up development of products for the prevention, screening, diagnosis, and treatment of cancer. The center would also be expected to support continued development of companion diagnostic tests, as well as new combinations of drugs, biologics, and devices to treat cancer.

Obama launched the moonshot in January during his final State of the Union address last month, saying Vice President Joe Biden would head the effort, launched this year with $195 million from NIH. Also this fiscal year, the Departments of Defense and Veterans Affairs have been directed to step up cancer research by funding the Centers of Excellence, focused on specific cancers and conducting large longitudinal studies intended to help identify risk factors and enhance treatment.

Even costlier is Obama’s proposal, announced Monday, to spend $1.8 billion on efforts to fight the Zika virus. The largest portion of the money (46% or $828 million) would go to the Centers for Disease Control and Prevention to support prevention and response strategies. Another $200 million would go to NIH and FDA toward vaccine research and diagnostic development and procurement efforts.

“While we appreciate the President’s willingness to devote special funds to pursuing the cancer ‘moonshot’ and addressing the Zika virus and opioid abuse, his proposed budget reduces funding for research aimed at diabetes, multiple sclerosis, rare diseases, and a host of other deadly and disabling health threats Americans struggle with each day,” Research!America president and CEO Mary Woolley said in a statement. “Our nation cannot afford to go one step forward and two steps back when it comes to the health of Americans.”


FDA User Fees Continue Rising

The FDA would see its total budget increased to $5.104 billion, though its budget authority would stay flat with FY2016, rising 0.5%—$14.616 million—to total $2.743 billion. While the FDA appears to enjoy a 7.6% bigger budget in FY 2017 under Obama’s proposed spending plan than this fiscal year, much of that increase reflects hikes in user fees paid by developers of drugs and other products regulated by the agency.

Washington plans to collect $2.286 billion in user fees next fiscal year, 13% more than in FY2016, under the FDA Safety and Innovation Act, which includes the fifth five-year authorization of the Prescription Drug User Fee Act through FY 2017.

More than one-third (nearly 38%) of those fees—the largest share—will come from prescription drug developers, from which the FDA plans to collect $865.653 million, up 1.7% or $14.172 million from the current fiscal year. Next highest is generic drug user fees, which would climb to $324.085 million (up $5.722 million or 1.8%); followed by biosimilar user fees, which would rise to $22.079 million (up $539,000 or 2.5%).

In FY 2017, user fees would account for 45% of FDA’s total budget, up from 42.5% this fiscal year, and 35% in FY 2012. That percentage swells to nearly two-thirds (65.1%) of the $1.408 billion to be spent on human drugs programs, up from 50% five years earlier.

“The agency remains fully committed to meeting the needs and high expectations of the American people regarding the products we regulate, as well as advancing the prevention, screening, diagnosis, and treatment of cancer,” said FDA acting commissioner Stephen Ostroff, M.D., in his statement.






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