When to Report to the FDA with Ronne Malham, GWCPM FDA Special Agent in Charge, Office of Criminal Investigations
Do you know when you have a case of suspected/confirmed diversion there is one more agency you should report to? It is the FDA’s Office of Criminal Investigations. OCI Special Agents are dedicated to protecting the health and welfare of the public by investigating criminal allegations falling within FDA’s jurisdiction. Ronne Malham and I discuss when and why a report to the OCI should be part of your reporting process. On their home page http://www.fda.gov/oci you will find press releases for cases they have investigated and a list of the field offices and contact numbers. Reach out to your field office and establish a relationship. Their partnership can be valuable for investigations and education.
Transcript:
Terri
Welcome back, listeners, to our podcast, Diversion Insights. I have the FDA with me, and I want to thank them for allowing this to happen. I know there’s a lot of hoops to jump through, but we have Ronne Malham, who is the office with the Office of Criminal Investigation, special Agent in Charge of the Chicago Field Office and Region. Thank you very much, Ronne, for taking time to talk with us today.
Ronne
Thank you, Terri. I appreciate the outreach, and I’m happy to be here.
Terri
I have one main question for you. It is something that has come up, I think, at a conference where I heard somebody speak. And I have never thought of calling the FDA when there is a diversion, suspected diversion, or confirmed diversion at any facility that I’ve been involved in. But I heard a comment from somebody that made me think, are we supposed to be doing that?
So that is my one main question for you today and what I want to discuss, when, if ever, should a facility reach out to the FDA if they have either a confirmed or suspected diversion at their institution?
Ronne
Okay, I’m happy to talk about this. What I can say is, when it comes to FDA, there’s different ways you can report suspected criminal activity. I’ll give you just a quick background on where the Office of Criminal Investigations fits within FDA, because we are a part of the Office of Regulatory Affairs within FDA. So FDA in general, obviously, as you and your listeners, I’m sure know, is involved in ensuring that regulated products in the US. Are safe and effective for use. We have support from several different areas in those regulated products. Drugs, devices, biologics foods, dietary supplements, vet medicine, tobacco. So FDA touches a lot of the regulated products within this country. We actually also regulate manufacturing and distribution within the United States. That’s over 2.4 trillion dollars worth of products, almost a quarter of every dollar that’s spent is regulated by the FDA. So within FDA is the Office of Regulatory Affairs, deals with regulatory and compliance issues, and within the Office of Regulatory Affairs is the Office of Criminal Investigations, of which I am a part of.
And mostly special agents and professional support staff are within the Office of Criminal Investigations. So we are essentially the supply chain law enforcement arm for federal government and federal violations. Criminal violations. So to get back to your initial question regarding reporting when to contact us. OCI has a link, very simple, online, which is probably the easiest way to report suspected criminal activity. It’s FDA.gov/oci and that will take you to a link to report suspected criminal activity. You can also reach out to your regional OCI field office. As I said, I’m in the Chicago field office, which covers the seven state midwest region. Shouldn’t take the place of any required state, local, or DEA reporting issues. But when there is a supply chain breach, tampering, diversion of any type of drug or other FDA regulated product, and suspected criminal activity is there, that’s when the report goes to OCI.
Terri
Okay, so you mentioned tampering, and I definitely think of the FDA when it comes to tampering, really more on that larger scale. Somebody’s tampered with something that has reached out to the public. I’ll be honest, I’ve never thought about it in terms of a specific individual tampering with something that goes to individual patients inside of a facility. Right. It’s still tampering if that’s their method of diversion. And when I say tampering, I am thinking specifically of, okay, we’re replacing, say, fentanyl with sterile water tampering. So would that case be a case of this person has done this however many times, a handful of times and they’ve been discovered? Then are we to report to the OCI?
Ronne
Yes, that would be a case that we would consider. We would review the facts on that along with our state and local partners, along with potentially DEA. But yes, the scenario that you described, we would consider a practitioner tampering. If it’s a licensed person that’s dealing with controlled substances or other regulated drugs, they’re tampering with it. And as you said, replacing with sterile water or in other cases to give some anecdotal examples, could be tap water or other issues. We see that there’s a great risk to public health. There risk to harm to the patient. Even if it’s one patient too many. Give you just a little bit of feedback. Our agents, special agents in every region, go out and do tampering presentations and outreach to hospital groups, industry groups, state and local law enforcement, state licensing bureaus, try to educate both our partners and our industry partners on what our role is, our supply chain role, supply chain law enforcement role.
So there’s different types of evidence that we look for. In those cases that you mentioned sterile water, but there can be evidence of narcotic waste, disproportionate, patient use of narcotics versus their peers for one practitioner versus peers. Audit, audits, especially some new audit diagnostic tools, could show red flags in the system. And our agents, along with our state partners, can take a look at those red flags and potential evidence and see if there’s an issue that we can get involved with.
Terri
Interesting. Okay, so you’ve mentioned a few things then we talked about specifically tampering. But if their method of diversion was simply not actually wasting it and taking it for themselves, or patient has an order for two and they only give them one and they keep one for themselves. That’s not tampering by the definition that I think of tampering, which maybe I’m wrong. So you get involved in those cases as well then? Or do you consider that tampering? Is my definition wrong?
Ronne
So I would say on a case-by-case basis, if there is a practitioner that’s in some way diverting or tampering, which again, to not get down in the weeds too much with what the legal definition would be, if you are somehow removing replacing the drug reactive ingredient in it, I think that’s pretty safe to call that tampering. If it’s stealing, theft, or diversion of it, where you’re not putting something that is not the safe and effective product back into the patient supply, we would still consider that, especially because if we have licensed practitioners that are committing crimes within the supply chain, that still falls within the purview of our protection of the public health. It may or may not be a case that OCI opens to a criminal investigation, but it could always be something we work with our state and local partners to address the issue if it’s not something that rises to an OCI case.
Terri
Okay, all right, so I think most places, obviously we know we need to report to the DEA, and so I see that happen. And most, if not all states need to report to the Board of Pharmacy because it’s a medication, and then the licensing board for whoever the professional is, whatever licensing board they belong to. What does OCI bring to the table or what did they do that is different than I guess it would be? Mostly the DEA is where there might be some overlap. Obviously, you’re going to be very different than the licensing agency and I’m guessing the pharmacy board as well. So how do you approach things that is maybe different, or what does OCI bring to the table that is necessary? I guess that is different.
Ronne
Sure. So we work, I would say, very frequently with DEA and DEA diversion groups when it comes to practitioner tampering or diversion, or if there’s a case of theft and drug diversion where a practitioner or someone within the supply chain is diverting for illegal use, say outside of the supply chain. But as far as what we bring to the table, I think I can speak for most of our agents here within our agency. We all come from other federal agencies first. So I would say it’s a task force of talent is how we like to refer for the agents here. Our agents come to OCI, usually with years of experience, at least several years with another big federal agency. So think of places like Homeland Security Investigations. DEA Postal Inspection Service us. Secret Service, that’s just to name a few. That’s definitely not exclusive, but those agents come with their years of experience in working different types of complex criminal investigations and then we work as a team here.
You might get an agent from one or two different agencies that are putting their past experience together to work on a complex case here. So we get a case referred on supply chain criminal activity. They’re putting their experience to work, their talents to work with the state and local partners, and to bring that case forward. And as our agents have experience with tamperings, they know what to look for. They can work with an industry partner, say, a hospital group, a long-term care center, or another industry partner that maybe hasn’t dealt with tampering before. And an audit has produced a very visible red flag saying, hey, we have an issue with this practitioner. It’s really standing out that there’s an issue with several vials or even potentially hundreds of vials. What should we do here? Our agents can get involved quickly, quietly, and work with the industry partner to say, okay, this is the evidence we’d like to take a look at.
This is what we’d like you to look at here and see if there’s a problem. If it is, it’s something that we can address and potentially talk to this person, get some potential statements that would help us in working in criminal investigation. So I think it’s safe to say no industry partner wants someone who’s diverting medication that’s going to affect patient health.
Terri
Okay, so that’s interesting. That almost sounds like if in my state I had something and I couldn’t come to a conclusion because sometimes our cases end that way. It’s like there’s enough here to make me think and we’re pretty uncomfortable. But short of an admission, it’s like, I’m pretty sure, but that if we reached out to your office, you may help us finish that investigation and maybe come to a more definitive conclusion along the way. Right.
Ronne
We can definitely bring experience into the situation. We can look at what has been done in that particular instance. And, yes, speaking from a lot of experience with different cases, the interviews that our agents would have with a potential suspect, subject, or even a witness might bring more information forward that would resolve the issue, lead to further evidence, or, in some cases, get an omission of guilt. That would help us make it a very clear-cut conclusion to what would have happened.
Terri
Right. Yeah. Because I would lay money down. You’re a better interviewer than most of us have in our facilities. So you’ve got more experience with that for sure. Okay, so just typically facilities are hesitant to call other agencies in, right? Because once they’re in the door, the thought is true or not true, I don’t know. But the thought is once we let them in the door, then there’s a risk that they will find something else that is completely unrelated to this. And so we definitely don’t want to call any additional people in. How does the OCI handle that if they were to go into a facility for a specific investigation? Do you have any kind of boundaries that you put up for yourself? Or is it just an invitation that the facility may end up, for lack of a better word, regretting calling you in?
Ronne
So what I can say is, from the Office of Criminal Investigation standpoint, we look at a report of suspected criminal activity as an offer of partnership. We’d like to come in as partners to help the team that’s identified the problem investigate it, see if there is a public health issue, see if there’s an issue that we can get involved in. So OCI is separate and distinct within the FDA, where we investigate suspected criminal activity. I think, at least in my experience in the past, there is in talking to industry groups the focus on the letters FDA and less of a focus on the letters OCI. But it’s an important distinction within what we do. They’re used to seeing regulators, compliance officials, showing up for inspections and looking for civil investigation or civil inspection issues. We do not deal with inspection issues before contact, and we’re dealing with investigating the criminal activity that’s reported.
So usually that’s something that once we can get that distinction out there, they see that we’re a law enforcement agency similar to contacting a different law enforcement agency such as the FBI or DEA, not an issue. We’re focused on that issue. We’re going to work with our partners to investigate that issue.
Terri
Okay. Now many times local law enforcement doesn’t want to get involved. Hospitals will call and they’re just like, this is not our thing. And then eventually hospitals just stop calling because that’s the response that they get. So that’s an interesting take on that. Then if you’re more like law enforcement, but the local are saying, no, we’re not going to get involved, then if you come in, your office comes in and you find that there is something more where charges should be pressed from a criminal perspective, then is it safe to assume that you would take care of that? Or do you work with local law enforcement then to get that done? Or how does that work?
Ronne
Sure. So I think as far as the criminal process goes in general, what you’re saying is correct. So contacting us either through the online portal or through the regional field office by phone. If an agent gets involved, we identify criminal activity, then we’re always going to find the appropriate prosecutorial venue. And speaking from regional experience here, and just anecdotal experience from OCI in general, on that website, you can see the press releases that have gone out. Any of your listeners can click through that OCI portal and go to the press release and see press releases that have gone for the federal venue. So we’ll use our prosecutorial, assistant US. Attorneys on the prosecution side that will take that through federal court. In other cases, it might be state court through an attorney general’s office in the appropriate state, or even through the local jurisdiction, district attorney or state’s attorney.
But we do work with if there’s criminal activity there, we are going to work the case with our appropriate partners or support if it’s a local issue with a local criminal prosecutorial partner such as a local police agency. With the state’s attorney as far as we can on the issue because we believe anytime there’s an incident like this, it’s important to the public health.
Terri
Okay. And would all incidents, whether it’s one or 20, be considered criminal if something is theft, whether tampered or not theft from patients?
Ronne
To answer your question, if it is a theft. If a theft occurred, it’s easier for us to say, okay, there’s an incident that occurred that meets the definition of what we believe is legal guidelines for a criminal act. But then we have to work with our prosecution partners to see if it meets the standards for any of those different districts. So, as I said, if it doesn’t rise to a federal criminal referral, then we can work with a state or local partner and see if it meets their needs. But usually, it’s a prosecutorial decision. Even if we think that a criminal act has occurred, if we’re going to push it forward through prosecution, that decision also has to be with our legal partners on the prosecution side.
Terri
Ok, alright. How do you get your referrals? Because I’ll tell you honestly, I don’t think I’ve ever known any facility to report to the FDA, so it doesn’t seem like it’s coming directly from facilities, or at least not a lot of them anyway. So how do you get your referrals? Where do they typically come from? And are you guys doing I mean, you did say you were doing some education. Are you working toward reaching out to the individual institutions and letting them know, hey, you’re supposed to add us to the list of people that you report to?
Ronne
Definitely. I think it’s a combination of those things that you mentioned. So we do get off-hand reports. If they come through our website or portal and we’ll assess those, they’ll go through our headquarters for review and then be issued out to the appropriate region. The outreach is a big part of this. We believe that both our agents, our regional managers, our group managers, it’s an outreach effort on every level of OCI because of the issue with diversions and tamperings. And that outreach is giving presentations to everything from giving presentations to prosecution partners to industry groups.
Where we’ll come in, we’ll show photos and PowerPoint presentations of past cases, talk about different the various different types of referrals we’ve got, and things that industry groups can look for, and that will lead to calls down the line. Two or three months later, a hospital group could call and say, hey, your agent was out here two months ago presenting on this, and I think I have an issue. Can I talk to an agent about it? And that phone call will potentially lead to a case. We also have the Drug Supply Chain Security Act DSCSA that your listeners may or may not be familiar with. Part of the Drug Quality and Security Act, it was passed in 2013, has some reporting that also occurs through that, and that can also be found through the FDA’s website. Those notifications can be made through that. It’s called an FDA Form 30 911 and submit through email. And that’s reviewed by OCI and also through our Oats or Partners Office of Drug Security, Integrity, and Response. Those submissions are reviewed there, and that can potentially turn into a referral as well.
Terri
The education, is that more along the lines of educating what your office does and when they should come to you and what that process is? Or do you also provide education to facilities on drug diversion and what it looks like and how to watch for it as well?
Ronne
I think it’s both. So I’ve personally done presentations on both of those. So if we have a change in leadership in the U.S. Attorney’s office or a state partner office within our region, say we have some new management there or new prosecutors there, we’ll go and do what we call an OCI 101 presentation, which is about our agency and about our agents and the different lanes that we investigate, such as supply chain integrity and law enforcement. We’ve also done specific Tampering presentations, and usually, we ask agents that are more experienced in tamperings and have seen various amounts of them to do those presentations to industry groups and say, hey, these are the things that we’ve seen. These are the things that we can bring up and show you what to look for in our experience.
Terri
So hospitals could reach out and ask for some of that education to come in and educate maybe their leadership group or their frontline managers on things that they should be looking for and things to watch for. Is that something that your office would do then if somebody reached out to you?
Ronne
Absolutely. And I don’t want to speak blanketly for every regional field office. The inquiry starts with each regional office. And if it’s a fit, especially with the things we’ve talked about here, I think it’s safe to say that all of our managers, our agents, are eager to do that. Increase communication, and increase education about what OCI does, which will lead to quality referrals that we can protect the health, protect the public health by getting involved in.
Terri
Perfect. Okay, well, this is great. This was definitely something new for me. So I bet it’s going to be new information for a lot of the listeners out there. And if there are those of you out there that have reported to OCI before and have anything to share, certainly, please let us know how that went, because I think a lot of us, it’s new. It’s new for us. Thank you very much, Ronne, for your time. Thank you, everybody, for listening. Thanks, Ronne.
Ronne
Thank you, Terri. Have a great day.
