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Opioid epidemic needs innovative, bold efforts and more funding, officials say


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Opioid epidemic needs innovative, bold efforts and more funding, officials say

Since May, Francis Collins, director of the National Institutes of Health, has been seeking partners from the biopharmaceutical industry for an initiative aimed at accelerating the development of nonaddictive alternatives to opioids and better overdose-reversal agents to address the current epidemic in the U.S.

Like other audacious goals where Americans have achieved great things, such as going to the moon and mapping the human genome, becoming an addiction-free nation will require the U.S. to go boldly, Collins told the Senate Health, Education, Labor and Pensions Committee Oct. 5.

But so far, not a single drugmaker has stepped up to be part of the NIH's initiative, an agency spokeswoman confirmed to S&P Global Market Intelligence.

Stephen Ubl, the head of the Pharmaceutical Research and Manufacturers of America — whose public relations campaign slogan, coincidentally, is "go boldly" — told the White House opioid commission in late September that companies were waiting for the government to make a firm commitment of providing funds before industry was "prepared to do its share."

Doing what Collins has in mind is going to take "hundreds of millions of dollars," he told the Senate panel.

"We have no special resources set aside for this," he said.

If the U.S. is going to tackle the opioid crisis, it is going to take an all-hands-on-deck effort, Collins said.

He suggested undertaking a coordinated enterprise focused on prevention, treatment and research that perhaps could be tested in a demonstration project in a handful of states, "and then see what we could achieve in terms of really changing the whole landscape."

Devastating the nation

"The opioid crisis is tearing our communities apart, tearing families apart and posing an enormous challenge to health care providers and law enforcement officials," said Sen. Lamar Alexander, R-Tenn., chairman of the Senate panel.

Since 2000, more than 300,000 Americans have died of an opioid overdose, according to Health and Human Services. Preliminary data for 2016 indicate that at least 64,000 Americans died of drug overdoses — the highest number ever recorded in the U.S., the agency said in a statement to the Senate committee.

"America's opioid overdose epidemic affects people from every community and it is one of the few public health problems that is getting worse instead of better," Debra Houry, director of the Centers for Disease Control and Prevention's National Center for Injury Prevention and Control, told the Senate committee.

She noted the opioid crisis has led to a drop in life expectancy for the first time since 1993, when the U.S. was at the height of the HIV/AIDS epidemic.

FDA actions

"This crisis has gotten so large and pervasive that it's simply beyond the scope of any one of our agencies to make a meaningful impact," Food and Drug Administration Commissioner Scott Gottlieb told lawmakers. "It's only in partnership that we're going to slowly reverse the trend and help move more people towards a life of sobriety."

Gottlieb said the FDA is focused on three domains of activity: Cutting the rate of addiction by reducing overall exposure to opioids; innovating to make the drugs less prone to abuse or to replace them entirely by nonaddictive pain treatments or medical devices; and pursuing better medical therapies to help those addicted to transition to sobriety.

"We know that most people addicted to opioids will be medically addicted. Their first exposure to opioids will be from a legitimate prescription," Gottlieb said.

The key is making sure only proper prescriptions are written and for the shortest duration of use necessary, he said.

The FDA chief said the agency wants to ensure doctors and patients are not getting the wrong idea that an opioid that has been deemed to have "abuse-deterrent" features is any less prone to addiction, "because we know it's not."

So the FDA has initiated a formal study examining the nomenclature the agency is using to describe abuse-deterrent properties, he said.

The agency also is working on a policy intended to guide the development of better medication-assisted treatment, or MAT, for opioid addiction and also is exploring ideas to help promote the broader adoption of those agents, Gottlieb said.

While insurers have been criticized for not always covering MATs and alternatives to opioids, in a statement to the Senate committee, the industry's lobbying group, America's Health Insurance Plans, called for greater access.

More authority

Another way the FDA could help curb the spread of opioids in the U.S. is by having greater and more updated seizure authorities, Gottlieb said.

"A lot of our seizure authorities are based on old maritime law and sometimes hard to implement against a modern threat," he said.

Collins said the NIH also could use some help from Congress in granting the agency a rapid funding mechanism called "other transaction authority" for use with opioids research. He said the NIH uses that authority in other areas, like precision medicine, "with great benefit."

"We could go a lot faster if we had some relief from some of the otherwise limitations of how quickly we could fund something that needs to happen," he said.