RSSTrue to their word, U.S. lawmakers are pushing forward with plans to give the NIH its second consecutive $2 billion funding bump.
Included in an omnibus spending bill Congress is slated to vote on in a few days, the increase ignores President Donald Trump's request for a $1.2 billion cut in NIH funding for the remainder of fiscal 2017 to help pay for more spending on defense.
Largely due to that bump, the Department of Health and Human Services (HHS) – which includes the FDA, NIH, CDC, as well as other agencies – is slated for a total fiscal 2017 budget of $73.5 billion. That's up $2.8 billion from last year's enacted level and $3.8 billion more than what President Barack Obama had proposed for fiscal 2017.
While Trump is expected to sign the 1,665-page package of spending bills to keep the government from shutting down at week's end, the congressional funding levels could set the stage for a 2018 budget battle. The president's "budget blueprint," unveiled in March, proposed cutting the NIH budget by 18 percent and making the FDA more reliant on industry funding by doubling user fees as part of a plan to chop $15.1 billion from HHS.
The administration said it planned to have its 2018 budget fleshed out by mid-May, giving Congress only a few months to come to terms on a spending deal before fiscal 2018 begins Oct. 1.
A series of continuing resolutions has kept the federal government funded – mostly at last year's levels – for much of fiscal 2017. The NIH increase included in the package released Sunday night will allow the agency to end the year with a flourish.
The legislation gives the NIH a $34.08 billion budget – 6.2 percent more than what the agency had in 2016 and nearly 3 percent more than what Obama had proposed in his 2017 budget.
The increase is expected to be distributed to every institute and center at the NIH "to continue investments in research that will save lives, lead to new drug and device development, reduce health care costs and improve the lives of all Americans," according to the budget agreement. Specifics include:
- $352 million to implement the 21st Century Cures Act;
- $152 million to research the Zika virus infection and provide for the preclinical and clinical development of vaccines and other countermeasures for Zika and other vector-borne diseases;
- a $400 million increase in Alzheimer's research;
- a $120 million increase for the Precision Medicine Initiative;
- a $110 million increase for the BRAIN Initiative;
- a $50 million increase for antibiotic resistance research;
- continued support for the Gabriella Miller Kids First pediatric research initiative; and
- support for an increase in the number of new and competing NIH Research Project Grants.
FDA FUNDING
The NIH isn't the only HHS agency in line for increased funding. The spending package would give the FDA a total discretionary appropriation of $4.66 billion, with 41 percent ($1.9 billion) of that coming from user fees. The total is $42 million more than what the FDA was given in fiscal 2016, but about 86 percent of the increase is directed toward implementation of the Food Safety and Modernization Act. Even with the increase, the FDA's 2017 budget will fall below the $5.1 billion Obama had requested.
One of the larger slices of the FDA budget – $492.2 million – will go to its drug center. The device center is slated for $329.8 million in tax dollars, with the Center for Biologics Evaluation and Research getting $215.4 million. Those appropriations will be supplemented by $754.5 million in PDUFA fees, $126.1 million in MDUFA fees, $323 million in generic drug user fees and $22.1 million in biosimilar user fees.
The agreement includes an increase of $10.9 million for medical product safety initiatives at the FDA, including $2.5 million to support the Precision Medicine Initiative. It also provides $6 million for Pediatric Device Consortium Grants and postmarket activities within the medical device program, and directs $2.5 million above the 2016 funding level to foreign high-risk inspections.
In addition, the spending package provides $10 million for the FDA to use to prevent, prepare for and respond domestically and internationally to emerging health threats, such as the Ebola and Zika viruses, and to develop necessary medical countermeasures and vaccines.
While no dollar signs are attached, the legislation urges the FDA to continue to work with Congress to address concerns about the regulation of laboratory-developed tests.
The CDC also will see a bit of a budget bump. Under the agreement, the CDC would receive $7.3 billion – $22 million above the 2016 level. Of that total, $6.3 billion would be in appropriated funds, with $891 million transferred from the Prevention and Public Health Fund. The legislation prioritizes CDC funding for critical disease prevention and biodefense activities, and includes $112 million to expand efforts to combat prescription drug abuse.