Former Rep Kennedy: we need to stop talking about how to solve the opioid crisis and start acting. Get rid of the barriers.Provider education is a barrier. (Health insurance) Reimbursement is a barrier. The Drug Enforcement Agency is a barrier. #RAForum17
Massachusetts Governor Charlie Baker: We have not done anywhere near as much investigator research around what works around addiction as we have around so many other areas and I would love to see the feds get serious with respect to this issue with research protocols and best practices as the feds are in so many other areas. If we think this is a crises then the feds ought to step up and play a bigger role in what helps and what works and why. #RAForum17
Massachussets Gov. Baker: You can’t think about (the opoioid crisis) just in terms of treatment and recovery, You have ot think about it in terms of prevention and education. I am a healthcare guy but the healthcare community created this crisis becuase they got extraordinarily casual about this. You can’t write 80% of the world’s opioids and not expect consequences to that. There has been information out there for awhile (about the crisis) , but for one reason or another it didn’t find its way into the public bloodstream until we were way down the road. We have got to get to the prevention and education part of this or we won't get to where we need to be. #RAForum17
Lucinda Maine: When I talked to people in Europe, they say we eliminated our (opioid) abuse problem by requiring electronic prescribing. And what we think about what we have learned in the US is we could squeeze down and get to the appropriate prescribing that addressees some pain well but what don’t we know about is the unintended consequences of making that portal very low and then igniting elicit drug use. #RAForum17
CDC Schuchat: We don’t (how many people are dying of (opioid overdoses) but we are making progress. We track deaths ...but there is lot of missing data and delay data..we know (there were) 64,000 deaths in 2016 #RAForum17
Rep. Kennedy: So we don’t have a real handle on the size and scope (of this crisis) and I thank you (Dr. Schuchat) for confirming that. #RAForum17
After QA with the first panel ends, FDA Commissioner Dr. Scott Gottlieb will offer remarks and hold an audience Q&A.
FDA Commissioner Dr. Scott Gottlieb is speaking now.
Food & Drug Administration Commissioner Scott Gottlieb: There are more 550 new drug applications (pending related to new gene therapies. #RAForum17
FDA Gottlieb: We will be issuing a roadmap that will serve as an organizing format (for the FDA regulatory process) in the coming weeks. #RAForum17
The second panel is about to get underway. It's called “’Failing Faster’ and Other Successes: an Update on Efforts to Speed Medical Progress.” Panelists include Nancy Brown of the American Heart Association and National Academy of Medicine President Dr. Victor Dzau.
FDA Gottlieb: How I am thinking about solving the opioid crisis from the FDA perspective, we have an important role to play, in terms of how we look at medical assissted therapy, and non addictive pain therapies. We are also looking at the biggest role we can play is in reducing overall (opioid) exposure and (prevent) new addiction crises. It will take a lot of work and we are part of that. We have an outsize influence... through the legal prescription (process), we know that a number of patients that are exposed to opioids will become addicted, so to reduce it we need to reduce exposure and make sure fewer are written. So no more 30 day supplies for tooth exraction. Only if you have developed a complication. ...we can require more controlled dispensing. So more 3 to 5 days supplies (of opioids), We be putting out proposed regulations on our thinking soon. We can work with provider groups to provide (more) labeling of these product sand what the appropriate dispensing should be. We can work with the dental community, so that it should not be more than 3 to 5 day doses (of opiods) that is one way we can achieve those goals. The reality is the only way to solve this and the enormity of it, is if we bend the rate of new addiction and we have to address that. #RAForum17
National Academy of Medicine president Victor Dzau: We (have ot) look at the price of drugs. How do we figure out how much you would like to be paid and why? Unless we address that, then we can’t take advantage of all these new drugs (in the pipeline.) #RAForum17
Duke University director Center for Health Policy Mark McClellan: More needs to be done to know if a drug or device is affecting a patient in a way that matters to them. A lot of what matters to patients isn’t captured (by the healthcare system). #RAForum17