President Obama’s proposed $3.99 trillion budget for the 2016 federal fiscal year offers small overall increases for NIH and FDA, but sizeable jumps in selected programs that reflect administration priorities for biopharma spending.

Obama is seeking $31.311 billion in overall program level funding for NIH, up 3.3% or an even $1 billion from the current fiscal year. However, the proposed NIH budget would more than double spending on the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, to $135 million from $65 million in FY2015; while adding $50 million or 8.5% to NIH spending for Alzheimer’s disease research, which would rise to $635 million; and adding $20 million or 24% to Big Data to Knowledge (BD2K), bringing that program to $105 million.

The president also proposed to boost spending nearly 28% for the NIH portion of the National Strategy to Combat Antibiotic Resistant Bacteria, which would rise to $461 million of a total $1.2 billion spread across numerous federal agencies; raise the number of “new and competing” grants by 13.5%, and spend 4% more on NIH’s translational medicine center. The budget for the National Center for Advancing Translational Sciences would rise in FY 2016 to $660.131 million, up 4% from the current year.

Also in Obama’s spending plan is the $215 million sought by the president for his precision medicine initiative, of which 93% would be spent by NIH—$130 million to create a million-person voluntary national research cohort, and $70 million for NIH’s National Cancer Institute to identify genomic drivers in cancer.

NIH said it planned to award 35,447 research project grants in FY 2016 costing $17.206 billion, 1,241 more grants and 5.3% or $873 million more in spending than FY2015. The grants number includes 10,303 new and competing grants, 1,227 more than FY2015. NIH estimates the success rate for grant applicants will increase to 19.3% from 17.2% in the current fiscal year.

Obama’s budget would also raise stipends 2% for predoctoral and postdoctoral trainees and fellows through the Ruth L. Kirschstein National Research Service Awards program, which would support a total 15,735 trainees across NIH’s institutes and centers.

“It's nice to see that this budget actually builds in another 2% increase, because that's a real issue for young people, and especially trainees. It's getting harder and harder to live on those amounts, so it's nice to see them (the Obama administration) put that into the budget right away,” Jennifer Zeitzer, deputy director of the Office of Public Affairs for the Federation of American Societies for Experimental Biology, told GEN.

Zeitzer was among advocates of greater NIH funding that applauded the proposed budget’s overall funding increase for the agency: “That's actually a really nice increase. 3.3% sounds small, but it's more than he [Obama] asked for in 2015, and more than inflation will be this year. It's a pretty robust number, all things considering.”

The U.S inflation rate stood at 0.8% through the 12 months ended December 2014, as published by the Bureal of Labor Statistics on January 16.

Also viewing the proposed budget favorably is the American Association for Cancer Research.

“We applaud President Obama’s FY 2016 budget request, both his proposal to provide NIH with a 3.3% increase, as well as for his exciting initiative on precision medicine, which is such an important and promising area of medical research,” Jon Retzlaff, managing director of AACR’s Office of Science Policy & Government Affairs, told GEN.

“The AACR will now be focused on making sure that Congress understands the importance of providing annual funding increases for NIH that takes into account inflation and provides for a healthy percentage of real growth,” Retzlaf said. “We also strongly believe that it’s important that NIH’s annual funding increases are predictable, consistent, and sustainable over the long-term.  We think the President’s FY 2016 proposal is a great start to meeting these objectives.”

Obama’s spending plan will require approval by Congress. Quick action is not expected since unlike last year, Republican majorities now prevail in the Senate as well as the House of Representatives. Republican Congressional leaders have already taken issue with several spending priorities of the Democratic president—especially proposals to raise taxes on corporations and those with the highest incomes to fund programs designed to benefit “middle class” Americans.

Mary Woolley, president and CEO of Research!America, said her group supported as “a starting point” Obama’s proposals to end the across-the-board budget cuts or “sequestration” enacted in 2011 and raise spending for agency programs.

“It is absolutely important to invest in initiatives that focus on precision medicine, Alzheimer’s, antimicrobial resistance and other growing health threats, but these investments should supplement, not supplant, the imperative of making up for a decade’s worth of lost ground,” Woolley said in a statement.

Research!America also voiced support for the Accelerating Biomedical Research Act, introduced last year by House of Representative Democrats. The measure calls for restoring NIH funding to FY 2003 level plus inflation since then—but is unlikely to fly as proposed in a Republican-majority Congress.

The FDA would see its total budget balloon to $4.93 billion, though its budget authority would increase 5.7% or $147.679 million, to nearly $2.744 billion. While FDA appears to enjoy a 9% bigger budget in FY 2016 under Obama’s proposed spending plan, much of that increase reflects hikes in user fees paid by developers of drugs and other products regulated by the agency.

Under the FDA Safety and Innovation Act (FDASIA), which includes the fifth five-year authorization of the Prescription Drug User Fee Act, Washington anticipated collecting $1.988 billion in prescription-drug, generic, and biosimilar drug user fees. However, in his FY 2016 budget proposal, Obama called instead for about $2.187 billion in user fees, up about 10% from FDASIA.

The president is proposing to collect 15% or $277.2 million more in user fees than in FY 2015.The largest share of user fees, $826.072 million, would be prescription-drug user fees. Those would rise 3.5% or $28.072 million from the current fiscal year. Next highest is generic drug user fees, which would climb to $320.029 million (up $7.913 million or 0.1%); followed by biosimilar user fees, which would rise to $21.540 million (up $526.000 or 2.5%).

In 2016, user fees would account for 44% of FDA’s total budget, up from 35% in FY 2012. That percentage swells to nearly two-thirds (65%) of the $1.372 billion to be spent on human drugs programs, up from 50% four years earlier.

“This budget accurately reflects the challenges FDA faces in a global regulatory environment, which is becoming increasingly complex and scientifically demanding,” FDA Commissioner Margaret Hamburg said in a statement.

Those challenges, according to FDA, include “Improving the safety and quality of medical products,” both drugs and devices—a policy priority for which the budget will set aside $2.7 billion, up $84.8 million or 3% over FY 2015. Less than half of the increase, of $33.2 million, will come from budget authority.

Yet that funding will pay for initiatives that include the FDA’s share of combating the growing threat of antibiotic resistance; facilitating the development and appropriate use of precision medicine tools; and continuing to implement FDASIA provisions such as the “unique facility identifier (UFI).” The UFI is designed to improve analysis of products for risk, combat counterfeiting and improve regulatory oversight, according to the agency.

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