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NIH outlines $500M spending plan for HEAL projects to combat opioid crisis

The $500 million in added funds Congress allotted to the National Institutes of Health earlier this year to address the opioid crisis will be spent on pursuing extended-release and longer-acting formulations of drugs to treat addiction, vaccines to protect against fentanyl and heroin overdoses and new non-addictive therapies to manage pain.

The funds backing the Helping to End Addiction Long-term, or HEAL, Initiative, unveiled April 4, will also be used to develop stronger and longer duration formulations of opioid overdose-reversal agents, like naloxone, whose effectiveness currently is short-lasting and requires multiple doses to reverse respiratory arrest in situations involving synthetic opioids, like fentanyl.

"Now is the time to channel the efforts of the scientific community to deliver effective — and sustainable — solutions to this formidable public health challenge," NIH Director Francis Collins, National Institute on Drug Abuse Director Nora Volkow and National Institute of Neurological Disorders and Stroke Director Walter Koroshetz wrote in a June 12 Journal of the American Medical Association article outlining the HEAL spending plan.

The NIH, which provided more details on its website, said $265.55 million would be spent in fiscal 2018, while the other $234.45 million is expected to be carried over into fiscal 2019.

While Congress gave the NIH the added funds for fiscal 2018, lawmakers permitted the agency to use the money over a two-year period, "so we don't have to spend every dime of that $500 million by Oct. 1," Collins told S&P Global Market Intelligence.

"We're glad about that because it's already pretty late in the fiscal year when we found out we had the funds," he said.

Collins said the biomedical research agency, whose funding is largely given out in grants, has "a whole bunch of new ideas for what we might fund in the next go-around, which we will be announcing in the fall."

Partnering but not accepting outside funds

The NIH chief noted, however, that the decisions for funding projects outlined for fiscal 2018 must be made soon, so the process for the first round of grant applications will need to move fast.

"There will be a lot of announcements over the course of the next several weeks," Collins said.

He said the NIH grant applications will be open to "all comers," though he anticipated the applicants to consist largely of academic institutions and small biotechnology and medical device makers and not large drugmakers, which have been "the main topic of concern."

After weighing the ethical dilemma of partnering with an industry whose products were at the center of the opioid epidemic, Collins decided in mid-April to go it alone and decline outside funding — a recommendation made earlier that month by a panel of outside advisers.

But Collins decided the HEAL program could accept certain nonmonetary industry assets, such as data and abandoned compounds — potentially even from drugmakers embroiled in litigation accusing them of helping to create the opioid crisis — as long as those resources are shared freely, without conditions or restraints on their use and all intellectual property rights are transferred to the agency or the NIH's foundation.

One of the NIH advisers, however, was concerned that an opioid maker may try to use such a donation as part of its litigation defense to argue that by providing material support and assets to the agency, it was evidence the company had done everything in its power to alleviate the situation and therefore it should not be subjected to any penalties.

"I don't know what we could do to prevent that," Collins said. "But I think the fact that they are not contributing cash diminishes the ability of that kind of argument to carry a lot of weight."

He emphasized that companies donating assets would "not be involved in the governance at all."

"If companies have valuable assets, compounds, for instance, that might have promise but have not been getting pursued, we wouldn't want to miss the chance to go forward with those," he said.

"What we tried to do was to preserve the promise of this public-private partnership, but avoid anything that appeared to be conflict of interests where companies would be contributing cash and being able to steer the scientific decision-making," Collins added.

Spending breakdown

A large part of the funding, $70.25 million, will be aimed at developing medicines to treat opioid use disorder and prevent and reverse opioid overdoses.

Another $5 million is expected to be targeted at developing immunotherapies, like vaccines to induce antibody-mediated opioid neutralization.

The NIH wants to use a coordinated, multidisciplinary consortium to pair investigators with expertise in opioid metabolism, biological transport and mechanisms of action with vaccine development programs and resources. The agency also plans to accelerate the progress of ongoing efforts to develop vaccines directed at heroin and other opioids.

Collins noted that Volkow's agency, the National Institute on Drug Abuse, has already been working on that vaccine development. But now the NIH is pulling in its National Institute of Allergy and Infectious Diseases "in an even more aggressive way to try to speed that up," Collins said.

Other NIH agencies have also been asked to contribute in whatever way they can, he added.

The largest portion of the funds, $96.25 million, will support the HEALing Communities Study — a multisite, national research effort to develop approaches for implementing effective interventions for opioid misuse, opioid use disorder and opioid overdose.

The NIH also plans to use $10 million of the allotted funds for expanding a series of pilot studies designed to assess the prevalence of neonatal opioid withdrawal syndrome, also called neonatal abstinence syndrome, which affects up to 10% of infants born in the U.S.