Bob Bianchi is the President and Chief of Scientific and Technical Affairs at the Prescription Drug Research Center in Bradenton FL. Mr. Bianchi retired as a forensic analytical chemist from the Drug Enforcement Administration (DEA) after 34 years of federal service, where he held increasingly responsible positions as an analytical chemist for the FDA and DEA to the chief of DEA’s Laboratory Operations Section. Mr. Bianchi was also Director of the DEA Special Testing and Research Laboratory where extractability experiments were conducted more than twenty years ago. Since 2005 he has been working with the pharmaceutical industry on developing in vitro protocols to evaluate abuse-deterrent formulations and has been actively involved in sharing his experience with the regulatory, pharmaceutical, law enforcement, and drug abuse communities. Mr. Bianchi is also a Special Government Employee for participation in the FDA Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee meetings.
Joe Lavelle: Hello this is Joe Lavelle your host of intrepid Healthcare, we are about to bring you one of two special interviews that we’ve conducted on the opioid crisis. Thank you so much to the great folks at NMS Labs for connecting us with Bob Bianchi and for helping us to make this interview happen.
Bob Bianchi is the President and Chief of Scientific and Technical Affairs at the Prescription Drug Research Center in Bradenton, Florida. Mr. Bianchi retired as a forensic analytics chemist from The Drug Enforcement Agency after 34 years of federal service where he held increasingly responsible positions as an analytical chemist for the FDA and the DEA to the chief of DEA laboratory’s operation section.
Mr. Bianchi was also a Director of the DEA Special Testing and Research Laboratory where extractability experiments were conducted more than 20 years ago. Since 2005 he has been working with a pharmaceutical industry on developing in-vitro protocols to evaluate abuse-deterrent formulations and has been actively involved in sharing his experience with regulatory, pharmaceutical, law enforcement and drug abuse communities. Mr. Bianchi is also a special government employee for participation in FDA Anesthetic and Life Support Drugs Advisory Committee, and the Drug Safety and Risk Management Advisory Committee meetings. Please go to www.nmslabs.com and see what other great things that folks of NMS Labs are doing in addition to help fight the opioid crisis, and now here’s our show.
Welcome back to intrepid Healthcare, I’m your host Joe Lavelle and I’m really looking forward to this conversation with another trailblazing innovator who’s returning to tell us more about the opioid crisis, we’re going to get right to it today. We’re rejoined by Bob Bianchi, President and Chief of Scientific and Technical Affairs at the Prescription Drug Research Center. Bob, welcome back to the show.
Robert Bianchi: Thank you Joe, I appreciate being able to talk to you this morning.
Joe Lavelle: Well, we certainly appreciate it. Bob, will you take a couple of minutes and remind the audience what you do in your role at the Prescription Drug Research Center?
Robert Bianchi: I’m a trained chemist and I am working with the pharmaceutical industry and the FDA in the area of abuse-deterrent formulations, and we work with a variety of companies to try to bring to the marketplace opioid formulations that are more difficult to abuse.
Joe Lavelle: Perfect, thank you for that. Bob in our previous discussion we talked about the government’s response to the opioid crisis, we’re going to turn a little bit towards the industry. How have the pharmaceutical manufacturers responded to the crisis?
Robert Bianchi: I think the manufacturers recognize there was a need to do something. So in addition to the incentives that the FDA has provided, the industry has formed several groups to collect and provide information and guidance to the FDA. One of them is the Cross-Company Abuse Liability Council and that’s a consortium of the industry representatives to improve public health by advancing the science of assessing drug abuse potential.
And the other group which I’m involved in is the Category 1 Focus Group, which is basically a forum made up of academia, regulatory and industry experts to develop the best practices for conducting laboratory in-vitro studies. The industry has brought forward 10 formulations that have been approved by the FDA. Five of them are oxycodone formulations, two of them are hydrocodone and three are morphine, and they are all extended release formulations that are designed for continuous therapy except for the most recent addition to the list Inspirion’s RoxyBondTM, which is an immediate release oxycodone.
We thought that because the extended release formulations have such a large dose of the opioid that would be the target for abuses, but in reality, most abuses and most prescriptions are written for immediate release formulations. So I think that the Inspirion is at the forefront of this immediate release oxycodone abuse deterrent formulation. So, the companies are trying to develop new pain medications and new delivery systems. We would love to have a chemical compound that can reduce or eliminate pain and not have the addicting properties of opioids.
I’m sure some time in the future we’re going to have such a thing, because we do have some great innovators out there that are coming up with great ideas. But perhaps the silver bullet to get the opioids off the market and use this new formulation, new chemical entity that is currently in development at some place.
Joe Lavelle: How are the drug distributors and then also the insurers and the payers responding to the opioid crisis?
Robert Bianchi: Unfortunately within the past year at least 25 cities and counties have filled civil cases against manufacturers, distributors and drug store chains (accused) to be responsible for the opioid epidemic. The law suits claim that the doctors and the drug companies exploited patients, they got them hooked on pills and caused the individual and states millions of dollars in reimbursables. We know that Cardinal Health Distribution had a problem in Florida where they were distributing large quantities of opioids to pharmacies that far exceeded the need of those particular populations, and they had their distribution suspended for a while and there was a fine levied as well.
So, on a federal law, the distributors are supposed to alert DEA if there is any evidence of suspicious orders, and that could be extremely large quantities or more frequent ordering, things that are out of the norm. And the system is designed to combat the diversion of the legal narcotics and get them into the black market. Some payers are planning to recommend or pay or reimburse for ADF formulations only. Some of them are resistant because of the cost, and I have a couple of numbers, Walgreens will sell a morphine 30mg tablet for about 23 cents. One of the newest abuse deterrent formulations for morphine formulation with the same concentration is about $18. There is a significant difference.
And oxycodone is in the same situation where a 40mg generic is less than $4, but the branded product is almost $12. So, we’re running into problems of who’s going to pay for this? The payers are not willing to pay for it, and it’s a problem if that’s the only thing that’s going to be available. To date there are 5 states that have successfully passed legislation with abuse-deterrent insurance requirements. This year there are 16 bills that have been introduced in 10 different states, but so far none of the ADF Bills have passed in 2017, and nearly 50% drop in bill introductions from 2016.
So, I’m not sure where we’re going with that and how that’s going to pan out in the future, but we’re trying our best, and the payers are playing a very important role in the use of these abuse-deterrent formulations.
Joe Lavelle: We’re famous on our show for having a crystal ball that we provide to our guests, as we give you that crystal ball to look into, how will the opioid crisis evolve over the next 5 years?
Robert Bianchi: Well, I think that if we wake up and start taking some action, education, treatment, enforcement, things are going to level off, but I don’t think that we’re going to solve the problem as long as we have so many products so readily available through legitimate distribution channels. So, unfortunately, it’s taken us some time to get here. We’ve been fighting the heroin epidemic for decades, we have not resolved that, and opioids are in the same category, although they are all legitimate pharmaceuticals, FDA approved, doctor’s prescribed, they are still dangerous.
So, we need to step up to the plate and do a better job of educating our children in particular, as well as our physicians that are prescribing all these things, giving them some other tools that they can recommend instead of going directly to opioids.
Joe Lavelle: Outstanding. Bob, you’ve provided us with such great information over the course of now two interviews, we really appreciate you stopping by and sharing all this with us.
Robert Bianchi: Well, it’s a pleasure to share this information because the more people that get this information the better chance we’re going to have of resolving this scourge that’s taking over the lives of so many people in the United States.
Joe Lavelle: I couldn’t have said it better, and we really appreciate your willingness to lead the effort. That wraps this broadcast, on behalf of our guest Bob Bianchi, I’m Joe Lavelle and we’ll see you soon on intrepid Healthcare.
