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Biomedical research, opioid crisis to get billions under 'omnibus' spending bill

House and Senate leaders have agreed to give the National Institutes of Health a $3 billion boost in funding under the $1.3 trillion omnibus spending package unveiled late March 21.

The bill, which comes halfway into the fiscal year, also will allot nearly $4 billion for combating the opioid crisis, with $500 million of that going to the NIH.

The biomedical research agency has been waiting for funds to move forward on its public-private opioids partnership aimed at accelerating the development of nonaddictive pain medicine alternatives and better overdose-reversal agents.

If enacted, the NIH's fiscal 2018 funding would total more than $37 billion, its largest budget ever.

The bill invests $1.8 billion in Alzheimer's disease research, a $414 million boost over last year.

It also provides $400 million, or a $140 million increase over last year, for the Brain Research through Application of Innovative Neurotechnologies initiative, a public-private project launched by the Obama administration in April 2013. The initiative's aim is to shed light on the complex links between brain function and behavior, which could eventually lead to new preventive therapies or cures for conditions such as autism, schizophrenia, epilepsy and Alzheimer's.

The spending package also includes $290 million for the NIH's precision medicine "All of Us" research initiative, which is another public-private project that was launched by then-President Barack Obama. The omnibus provides a $60 million increase for the initiative.

Another Obama-era initiative, the Cancer Moonshot, will get $300 million under the package.

Universal flu vaccine

Among the other areas gaining funds at the NIH will be research to develop a universal flu vaccine, which will be allotted $100 million — a $40 million boost over last year.

Anthony Fauci, director of the NIH's National Institute of Allergy and Infectious Diseases, told S&P Global Market Intelligence in February the "time is ripe" now for a "full-court press" in investment and resources from all stakeholders to make a universal flu vaccine a reality. Fauci said the best way to do that was to build a consortium of multidisciplinary scientists from government, academia and industry.

Fauci and other government officials told House lawmakers at a March 8 hearing that the only way the biopharmaceutical industry would achieve a universal flu vaccine was if it finally moved away from the 70-year-old antiquated egg-based process and used the modern techniques, like recombinant DNA technologies.

FDA gets small increase

The U.S. Food and Drug Administration would be appropriated $2.9 billion in discretionary funding under the omnibus bill $135 million over the 2017 enacted level, which is a relatively small increase for the agency.

That increase includes $15 million to fund the FDA's Oncology Center of Excellence, or OCE, which was established under Cancer Moonshot to employ a more integrated approach to speed new cancer therapies to the market.

The idea behind the OCE is to bring together the FDA's expert cancer scientists from its three medical product centers — the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health — under an umbrella unit where they will engage in coordinated evaluations of drugs, biologics, devices and diagnostics.

Together with the user fees the FDA obtains from the industries it regulates, its total fiscal 2018 funding is expected to be $5.15 billion.

The bill will also provide a one-time payment of $94 million to expand the FDA's efforts at international mail facilities to address the opioid crisis.

In addition, the bill appropriates $60 million authorized under the 21st Century Cures Act, signed by Obama in December 2016, to accelerate medical product development.

Moving money around

Under the omnibus legislation, the Centers for Disease Control and Prevention would be appropriated $8.3 billion for the year, an increase of $1.1 billion over fiscal 2017.

Most of that increase, $801 million, is being transferred from the Prevention and Public Health Fund, while $240 million is coming from the Nonrecurring Expenses Fund.

If enacted, Congress will add $45 million to the CDC's public health preparedness and response programs, bringing its total funding for the year to $1.45 billion.

Those additional funds are intended to ensure the Strategic National Stockpile — a cache of drugs and other medical supplies stored for responding to large-scale emergencies, like a bioterrorism attack or a pandemic virus — and that state and local preparedness capacity are adequate.

Congress will also provide the CDC $480 million for construction of a new biosafety level 4 laboratory — the labs where experiments using some of the world's most dangerous pathogens, like anthrax, smallpox, H5N1 flu and Ebola, are conducted.