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He was a lobbyist for the pharmaceutical industry in the mid-80s when the Drug Enforcement Administration (DEA) first moved to require that distributors of ephedrine and pseudoephedrine check customers' identities and makes sales records available to the DEA. However, his industry opposed regulation. Here, he summarizes their position and explains how a compromise bill was finally negotiated. Unfortunately, however, it left loopholes meth traffickers quickly exploited. This is an edited transcript of an interview conducted on Nov. 5, 2005.

What are the particular benefits of pseudoephedrine, and why did the pharmaceutical industry want to preserve its over-the-counter availability?

… It just so happens that pseudoephedrine is one of the most effective and safe ingredients to be used in cold medicines. Without the ingredient, the product is not going to work as well. …

The key here is to try to establish a delicate balance between keeping the product in the consumer's hands and at the same time stopping the criminal from diverting that ingredient into harmful and illegal street drugs. It's a very difficult thing to strike that balance. We're working on that right now, and in all but one state, pseudoephedrine is still available without a prescription. …

What was the DEA trying to accomplish in 1986, and how did you feel about that?

Well, simply put, in 1986 DEA was trying to pass a law that would keep active ingredients like pseudoephedrine or ephedrine out of the criminal's hands. We supported this, but unfortunately, legal, FDA-approved, over-the-counter medicines got caught up in this battle.

...we felt that we were being treated just like a Colombian drug lord.

Now, when you talk about legislation, you have to keep in mind, there are two fundamental requirements: There must be a significant need, and the principal goal must be the protection of the public interest. And [from] that perspective, in '86, in the protection of the public interest, there were two twin, and by their very nature, competing goals: keeping the ingredient in the hands of the American consumer, but keeping it away from the criminal.

We all thought we could find a way to do this, but unfortunately we felt DEA was confused about who was the bad guy. They seemed to use a broad brush and include[d] anybody that was involved in these ingredients in the bad-guy category, and it was our feeling that what they were really saying to us was that "We're from the DEA, and this is the way it's got to be, and if over-the-counter medicines have to go down the tubes, well, that's just too bad." They also sort of had the mentality that "We're from the government, and we can do anything we want."

Our response was: "Whoa, hold it a minute, folks. Don't rush through this, because if we do things too quickly, you're going to risk throwing the baby out with the bathwater." Unfortunately, our concerns fell on deaf ears.

What are your thoughts on that?

… Well, you know, these are good people, and they deserve our support and respect. But you have to understand where they were coming from. Unlike FDA [Food and Drug Administration], which regulates, DEA enforces. They have a different way of thinking. They have a different mentality. They carry guns. They use these guns. DEA agents are killed. Now, in the jungles of South America, they need guns. But when you're working in United States Congress, you don't need to carry a gun with you. And we felt that we were being treated just like a Colombian drug lord. And we weren't. We were legitimate, FDA-approved pharmaceutical companies, and we felt we deserved equal respect. We did not get it.

What do you mean by that ?

… Well … when I graduated from law school too many years ago, my congressman who I worked for taught me the coalition approach, and that was the idea of building and forging partnerships. When you identify a need, you call everybody you know, and you say, "Will you help us work this problem out?"

DEA went about it backwards. They introduced a bill. I found out about it by reading in the Congressional Record. It was a total surprise. One obviously becomes a little defensive when you find out about something like that. We didn't feel like we were part of the process. They could have called the pharmaceutical industry, the chemical, food, drugstore, pharmacy [industries] -- they could have called all these people and said, "Help us." We would have helped them, but when they approached it, our response was, "Fellas, we can only get behind this bill if we're onboard." We weren't.

What did you do to strike a balance with the DEA's interest?

Well, we kept calling, and we finally got through, but we weren't making much progress. If you ever called your TV repair company for cable repair, you'll know the response we got from DEA. Actually, we had the same goal, but we simply couldn't get their attention.

Now, what would you do if you had a bill that was out there that was going to negatively affect your industry, and the people won't even talk to you? It really wouldn't make any difference if you were in the dill pickle industry or the cold medication industry. You would naturally do simply what you have to do. So quite frankly, we appealed to a higher authority. Now, we were not asking for any special treatment. We were just asking for respect and recognition as an equal player, which we should have been afforded in the first place. We finally got it, and we met with DEA in earnest negotiations.

Describe how the DEA ended up in the Indian Treaty Room and what happened in those negotiations.

They got a phone call, and it wasn't one of these phone calls where they were told to do something or not to do something. What the phone call said was: "For God's sakes, talk to these people. They don't have three eyes."

So we met them at the White House complex in the Indian Treaty Room, and I suspect that it was no coincidence that this room was selected. You know, the warring tribes had to come together. We smoked the peace pipe, and we formed one anti-meth nation.

It really was the turning point in the whole process, because it was the first time the DEA treated us as part of the solution instead of part of the problem. And with that view, we were able to hammer out a bill which met the twin goals of keeping the product for the consumer and out of the criminals' hands.

It was a modest step. It was an incremental process, and other steps would have to be taken. But you know, you don't shoot for the moon at the first time. …

Was the bill ideal? No compromise bill is ideal. Would it have to be changed or amended? Yes. It has to be changed or amended today. Why? Because the criminal is still out there doing bad things, and what we need to be careful about is that we go about this in the proper, thoughtful manner. The important thing is that when we do this, we must keep in mind that we want to do maximum damage to the criminal and minimum damage to the consumer and the legitimate businessman.

Now, there are some people out there that have criticized this original 1987 effort. They weren't there. They did not have to strike this delicate balance. They have said that it was a bill full of loopholes that should have been anticipated. We didn't have a crystal ball. We could only work in the present; we could not work in the future. …

Looking back over the whole process over the years, what can we learn?

The debate goes on now, because the bad guys are still out there making street drugs, and this original bill is going to have to be amended.

There are at least two bills out there in Congress right now that, in varying ways, address the issue of diversion of legitimate FDA-approved ingredients into street drugs. The bills also do a number of other things that have nothing to do with cold medications.

Now, I wouldn't venture an opinion on which way to go. I would leave that up to the thoughtful people that are in the current legislative process. But I would say one thing: that 15 years from now, you won't be seeing me criticizing what these people are doing today.

I would suggest, in reflection, to keep in mind that we want to do maximum damage to the criminal and minimum damage to the legitimate businessperson. And if [there's] one thing that comes out of this whole lesson from the past, it's let's work together. If you want to accomplish something, you've got to work together from the very beginning.


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posted feb. 14, 2006

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