DEA suggesting new method of regulating legal opioids

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The Drug Enforcement Administration doesn’t just nab illegal drug traffickers. It also regulates the production of legal but dangerous drugs like opioids. Responding to a law enacted in 2018 the DEA is proposing new regulations for how it grants quotas in an effort to curb addiction. The assistant administrator for diversion control, Tim McDermott, joined Federal Drive with Tom Temin to describe how this process works.

Interview transcript:

Tom Temin: Mr. McDermott, good to have you on.

Tim McDermott: Good to be here.

Tom Temin: So tell us about diversion. What does that mean? And I guess there’s a whole big DEA apparatus that deals with it?

Tim McDermott: That’s correct. The mission of DEA’s diversion control division is to prevent, detect and investigate the diversion of controlled pharmaceuticals and listed chemicals from legitimate sources while ensuring adequate and uninterrupted supply for legitimate medical, commercial and scientific needs. And what does that mean? Essentially, that DEA has oversight of the pharmaceutical industry’s — of industry, where we are ensuring that there’s adequate quota that the diversion of legal listed pharmaceuticals are — adhere to the [Controlled Substances Act], as well as we’re ensuring that there is limited diversion of these so that the uninterrupted supply of pharmaceuticals can be used in the medical industry.

Tom Temin: So diversion means that somehow they make it out into the marketplace, not through a prescription and not through use by the intended individual legitimately.

Tim McDermott: Correct, and so what you would see today is four to five new users of heroin start by taking pills that are in your medicine cabinet at home. And so they’re diverting it from its intended use, the majority of time when it’s — when people end up being addicted to these drugs. If you were to have a back surgery, for example, and the doctor prescribed you hydrocodone and you used it for the purpose of that, then that’s what it’s intended for. But when you use it for recreational purposes, that’s where diversion would happen.

Tom Temin: Got it, so diversion could be misused by the original holder of the drug. Or it could be, “Hey, I’ve got 80 pills left over. You want ’em” -type of thing.

Tim McDermott: Correct, and quite honestly, that’s what we see on the street a lot where typically it’s about a dollar a milligram and people would be selling those on the street. And if you had 100 pills that was prescribed to you and you diverted from its intended use, you could do the math and you’d have a $3,000, minus what you paid for.

Tom Temin: Sure. Now doctors, usually in hospitals, decide how many pills people get in a prescription. And if the industry responds by manufacturing based on what those demand signals look like, how does quotas come into it? How can the manufacturer avoid the diversion if they’re responding to what the demand is from the medical establishment?

Tim McDermott: Great question. So what happens with the manufacturers that we have a system internally, and that system looks at the amounts that are being dispensed or the quota that they receive and then they end up dispensing to distributor and then, at the end of day, maybe to a pharmacy. So what they have to do is they have to know their customers. They have to be sure to know what the intended uses for and if something looks out of the ordinary in — actually this year, the end of this year in October we have a system called SORS, which is our [Suspicious Orders Report System], and they would have to say … OK, all of a sudden, for example, just make this up: If they typically sell to whoever 500 bottles of this, and then the next time they get one for 1,000 bottles of a schedule II, that’s gonna be suspicious and then you need to find out why. So if it happens to be there’s a new hospital in the area, well, that would be, ah, inadequate. And that would be something that —

Tom Temin: That would explain it.

Tim McDermott: The right thing to do, yeah, exactly. As opposed to if you were doing it for illicit purposes.

Tom Temin: Got it. And I guess, unfortunately, we see the cases come to light  — because I read all the Justice Department press releases, too — that often the chain of people that you trust in this whole thing are, betray that trust in the way they handle and order drugs, too, doctors and and distributors.

Tim McDermott: Yeah, that does happen. But what, one thing that the public needs to realize is that there’s 1.8 million registrants and less than a half a percent are actually doing things they shouldn’t be doing. So the system in itself is very regulated, and people are typically doing what they’re supposed to be doing.

Tom Temin: We’re speaking with Tim McDermott. He’s assistant administrator for diversion control at the Drug Enforcement Administration and the SUPPORT Act, which passed a couple of years ago, what did that specifically direct DEA to do and how have you responded?

Tim McDermott: The SUPPORT Act gave DEA a bunch of things to do. And one of the things to do is we have to estimate diversion. So we’re working with the FDA, CDC, Medicare, Medicaid, also working with the attorney general’s offices. And we also look at stuff outside of just those interagency partners to come up with, we believe is an estimated amount of diversion. And what we have to do is then look at when we come up with our annual quota, which is we’ll also refer to as our APQ, which is our aggregate production quota — we have to look at what amount of diversion is out there. There’s a variety of ways to do that. We can look at it based on total net disposals, trends in national rate of net disposals, actual inventories, projected demand, the extent of diversion on those that would be by cases that we have ongoing within the United States within DEA, relevant information from FDA CMS CDC. And then other areas, so we would look at overdose deaths in certain regions. And then we come up with the quota here to ensure that we’re meeting the medical, scientific research and industrial needs of the U.S., but also making sure that we’re limiting the possibility of diversion.

Tom Temin: So setting the quotas or resetting them, then, is really an act of rule-making?

Tim McDermott: It is, correct. And the proposal for the active rule-making makes us conform with the amendment to implement with the SUPPORT Act.

Tom Temin: Now you proposed rules in October. Is the comment period over? What’s the status of the new rules at this point?

Tim McDermott: We can’t talk about the status of it where we’re at. But what I can tell you is that we’re in the process and we have comments that we’ll get back to, those individuals that have proposed comments. That’s basically what I can tell you as of right now. But also part of the SUPPORT Act makes us go back and look at the supply. And part of that, typically a company would be able to have a 50% supply. Now it’s gonna go to a 30% supply of, you know, we’re talking typically the schedule II drugs.

Tom Temin: When you say 50 to 30% that’s of the monthly or yearly supply?

Tim McDermott: Correct.

Tom Temin: And I guess in this context, really, quota is maybe synonymous with limits on production.

Tim McDermott: It is, that’s correct.

Tom Temin: And in the rule-making that you have out there and the comments you received, did you get lots of individual comments as opposed to, say, mass generated comments from — I don’t know who would ever would do that in a drug-making, drug related rule-making. But I know a lot of agencies are dealing with how to deal with the large numbers of similar comments generated by a couple of sources.

Tim McDermott: Right, there’s hundreds of comments, so we’ll have to go back and answer them. But typically, a lot of the comments they will be similar. And so a lot of times we’ll be able to answer those comments and maybe one answer would be for multiple comments.

Tom Temin: Right and what’s the timeline? When do you hope to finalize the rule, the quotas?

Tim McDermott: Well, it’s a priority for us, and I can tell you we’re moving these as quickly as we can, so hopefully in the next, I would say hopefully within the next couple months.

Tom Temin: And is it fair to say the big object here is to reduce the amount of opioids, making it out of legitimate channels and uses and thereby, we hope, reduce some of the addiction that’s plaguing the nation?

Tim McDermott: That’s definitely that’s correct. But what I can tell you also is, since 2016 through 2020 combined for scheduled II of these opioids, we’re down about 55% today.

Tom Temin: A good piece of news then.

Tim McDermott: Yeah, and so, and that’s because a couple reasons: Number one is educating the public. Number two is the doctors are writing less prescriptions since January 2017 through December of 2019. It’s down, prescription writing is down 28%. And then pills that actually leave the pharmacy — they’re down about 35% that same time period.

Tom Temin: Tim McDermott is assistant administrator for diversion control at the Drug Enforcement Administration. Thanks so much for joining me.

Tim McDermott: You’re welcome.

Tom Temin: We’ll post this interview along with a link to more information at Hear The Federal Drive on your schedule. Subscribe at Apple Podcast or Podcastone.

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