White House Plans to Sue Opioid Makers

— President Trump said 'toughness' and 'strength' key to ending opioid epidemic

MedicalToday

WASHINGTON -- To stop the opioid crisis, President Trump said on Thursday, the country needs to be tougher on drug dealers and on drug manufacturers.

"We have pushers and we have drug dealers ... I mean they kill hundreds and hundreds of people, and most of them don't even go to jail ... We need strength with respect to the pushers and to the drug dealers. If we don't do that you're never going to solve the problem," he said during the .

"If you want to be weak and you want to talk about just blue-ribbon committees, that's not the answer. The answer is you have to have strength and you have to have toughness."

"Some countries have a very, very tough penalty, the ultimate penalty, and by the way they have much less of a drug problem than we do. So, we're going to have to be very strong on penalties."

Trump also fired a warning shot to opioid manufacturers.

"I've also spoken with [Attorney General] Jeff [Sessions] about bringing a lawsuit against some of these opioid companies," he said.

The administration will be rolling out new policies related to the epidemic over the next 3 weeks "and it will be very, very strong," Trump said.

Prior to the president's speech, Kellyanne Conway, White House counselor and a leader on the president's opioid initiatives, led two panel discussions: one on prevention and treatment of the epidemic and the other on law enforcement efforts.

The Trump administration has been criticized for failing to put money and other resources behind its rhetoric on opioids. At the request of Senate Democrats, the Government Accountability Office has agreed to open an investigation into the administration's actions or lack of them, .

During the first panel, Alex Azar, JD, Secretary of the Department of Health and Human Services, described steps HHS has taken since October 2017 when the administration declared the epidemic a public health emergency.

He mentioned an "Opioids Code-a-thon" in December that was organized to help programmers created new prevention tools such as apps that use available data to "monitor risky opioid prescribing and help providers assess their own prescribing levels," and compare them with their peers.

He highlighted the new streamlined process HHS had designed for substance use disorder treatment waivers, through which 5 state have received waivers to date.

Azar also described new draft guidance from the FDA that aims to speed the development of new medication-assisted treatment (MAT). That only one-third of treatment centers currently provide MAT is "unacceptable," he said.

Finally, he noted that the administration had doubled funding for state-level responses to the epidemic, from $500 million to $1 billion, and proposed $13 billion for the crisis in total.

David Shulkin, MD, Secretary of the Department of Veterans Affairs, touted an Opioids Safety Initiative, begun in 2012, under which the VA reduced opioid used in the agency by 41% -- primarily by shrinking the number of first-time prescriptions and instead choosing alternatives to opioids.

In addition, two months ago, the agency began for every VA medical center across the country.

"The highest in the country is in Roseburg, Oregon, at 20% of all prescriptions and the lowest is in Cleveland at 3%," Shulkin said.

He also highlighted the , VA's best practices for responding to the opioids crisis, which includes a step-wise approach to pain management (with opioids as a last resort for pain rather than the go-to therapy), monitoring of prescribing patterns using states' prescription drug monitoring programs (PDMP), academic detailing where the agency's pharmacists train doctors in proper prescribing habits, and distributing over 100,000 naloxone kits to first responders.

Lastly, Shulkin explained that veterans are given an informed consent document to sign before they use opioids, "because they have a shared responsibility in this."

Conway had another recommendation for stemming the crisis: "Why not make take-back day everyday?"

Most take-back programs for disposing of unwanted medications currently happen only once or twice a year, but Conway suggested partnering with pharmacists and first responders to expand those opportunities.

Earlier this week, Sessions announced a task force that aims to hold drug companies responsible for their role in the epidemic,

In the summit's second panel on Thursday, Sessions described other actions taken by the Justice Department to quash the epidemic, including including over 100 doctors and nurses in July, for healthcare fraud such as prescribing and distributing opioids.

"We want the death rate down and we'd like to see the amount of drugs prescribed down. If we are an outlier ... and we have Medicare, Medicaid, VA and private insurance paying for these drugs to make people sick, it makes no sense whatsoever. [It's] actually killing people. So we've got to tighten that up," he said.

Sessions said the Drug Enforcement Administration can pull a license for an improper prescriber before a criminal case is made, through civil lawsuits.

"We're looking to see if there's additional civil litigation that the Department of Justice can take independently of the state lawsuit," Sessions added.