Anti-Counterfeit Drug Initiative--Public Meeting

OVERVIEW

MR. TAYLOR: Can everyone take their seats? Thank you.

Okay. As I discussed earlier, I told you that the Commissioner of the Food and Drug Administration would have an opportunity to speak at 11 o'clock, and he is here. It is my pleasure and honor to introduce Dr. Mark McClellan, Commissioner of the Food and Drug Administration.

[Applause.]

COMMISSIONER McCLELLAN: John, thank you very much.

It's always a pleasure to be introduced by John. He definitely has a way of getting people's attention, quite a presence. And he's also been very busy lately. We are facing a number of new challenges to keeping the products that FDA regulates safe and secure. So from new food security regulations to keep our food imports secure, to dealing with new problems with prescription drug safety and security like those that we're talking about today, John and his team and FDA's enforcement activities have been very busy. I want to thank them for the great work that they are doing.

I also want to thank you all for coming today to meet with us and share your ideas and views on how we can do as effective a job as possible of keeping the American drug supply safe and secure. The United States has a very safe prescription drug supply, and FDA is working hard to keep it that way.

This is not something that we can take for granted. If you look around the world, in many countries a quarter or even a half or more of the prescription drugs that people take are not legitimate products. They may not work as intended, and that's a real public health concern. And although counterfeiting of drugs is not widespread in this country, we have seen an increase in counterfeiting activities. Our number of investigations has gone from about five per year in the 1990s to over 20 per year in the last several years. And even more worrisome, we have seen an increase in the sophistication, the cleverness, the technical capabilities of counterfeiters that are trying to get drugs into the U.S. distribution system.

This is a real public health threat. As we have seen from the counterfeit cases that we've already encountered and in many cases solved and put people in jail, counterfeit drug products may contain only inactive ingredients, they may contain incorrect ingredients, improper dosages, sub-potent or super-potent ingredients, or they may be contaminated. The result is risks to patients' health, either risks to their safety directly if the products are dangerous, or risks from people suffering from complications from the many diseases that prescription drugs can treat today. So this is a serious concern at FDA.

With these more sophisticated drug counterfeit operations, FDA and all law enforcement activities that are partnering with us need to be even more effective in meeting these new challenges.

I just got through touring some of the technology vendors next door, and for those of you who haven't had a chance to go over there yet, I highly recommend it. For those of you from the various companies that are coming up with innovative solutions, in many cases that have been applied to other industries besides pharmaceuticals, and in some cases they're starting to be applied to the health care industry, I want to thank you for your efforts. We need these fresh, innovative ideas for keeping our drug supply secure at an affordable price today more than ever.

There are many promising technologies out there. I had a chance to see some radiofrequency identification techniques, new applications of bar code labeling, new approaches to doing track and trace technology so that we can reliably, in ways that cannot easily be fraudulently faked, identify whether a product really is a legitimate one, it's come from a legitimate source and has not been tampered with along the way.

I've seen new technologies for packaging, new color-based technologies that embed multiple different layers of protection.

I've seen new anti-tampering technologies for drug packaging, even the tops of injectable drugs that can help keep the product secure.

And I've seen new technologies that can be used on the drugs themselves, from new color technologies to bar codes embedded, not just unit-of-dose packaging but actually on the drug, to other taggant and chemical technologies that are not harmful for patients but that can make it very easy to determine whether a product is safe or not. They do everything from make it easy for us or others to do chemical testing on the product's legitimacy to making it easier for patients to identify whether the product is a legitimate one or not by a distinctive taste.

So a lot of potentially valuable technologies out there that are in development right now, and in some cases are starting to be applied to the pharmaceutical industry. In some ways, the pharmaceutical industry is behind other industries where secure track and trace approaches and secure anti-counterfeiting technologies have become more widespread.

I heard some this morning about the fragrance industry where many of the technologies that might potentially be useful in pharmaceuticals can be applied.

And I want to thank our colleagues from other government agencies, such as the Department of Justice, the Bureau of Engraving and Printing, and the Secret Service, for sharing their expertise on counterfeiting technology with us.

I think as a result of meetings like this that we can really speed up development, the testing, the feasibility testing and the cost-effectiveness testing, of many of these technologies that are in development today. And as we are trying to do in other areas of FDA activities where there are new technologies that can be valuable, we want to bring them to benefit patients as soon as possible. And while many of these technologies do seem a few years away from widespread application, while they have not been fully tested yet and demonstrated to be feasible, I think that through meetings like this and through further steps that FDA will take to speed along the development and application of these technologies, we are on the cusp of a potentially much more secure drug supply using 21st century technology in the years ahead.

But as our colleagues who are also experts on counterfeiting technology have told us, there is no single magic bullet. Not only do many of these technologies need to go through some further developmental steps, counterfeiters are very sophisticated today, so this is a moving game. We constantly need to be finding ways to update our technologies. We constantly need to be thinking about whether we've got enough layers in place. There's no one magic bullet. We need to think simultaneously about a coordinated approach that involves tracking and tracing and product packaging and product-embedded technologies and others, multiple layers to keep our drug supply safe.

Our money supply, just the paper money, has more than 20 embedded technologies, both overt and covert and some that are only known to the Treasury Department that handles the money. We need multiple layers like that to assure security in prescription drugs as well, and we're going to be working to bring these proven technologies, to develop the proof for these technologies, and to bring them to improving our drug supply as quickly as possible. And this meeting and your input into that process is an essential part of getting there as soon as possible, getting to a secure drug supply based on up-to-date and constantly improving 21st century anti-counterfeiting technology.

I also want to highlight briefly a few other areas that FDA has stressed in our recent interim report from our Anti-Counterfeiting Task Force where we think we can do a more effective job in protecting Americans from unsafe counterfeit drugs, an even more effective job than we are doing today to keep our drug supply safe and secure. And I hope all of you here will help us both with your formal comments at this meeting, questions, comments, and other input that you send us. We have an open docket right now, and we really do want input from everyone who is interested in maintaining the security of our drug supply.

Let me just run through a few of these areas very quickly. One of the things that is evidenced to us in this work is that all of the participants in our drug distribution system, from manufacturers to wholesalers and distributors, to pharmacies, to patients, have a responsibility to help us prevent and detect the introduction of counterfeit drugs into our drug supply.

In particular, the businesses that are involved in the pharmaceutical manufacturing and distribution industry can help by adopting secure business practices. We think from what we've seen so far that some of the business practices in existence today can be improved as a means of deterring and detecting counterfeit drugs.

We've heard from and we've gotten a lot of feedback out to wholesaler organizations, for example, that are moving forward with developing more secure business practice models as a standard for their industry. And we're looking forward to working with all of the other stakeholders in the prescription drug distribution system to make sure that we have identified and are doing all we can to encourage the adoption of secure business practices to minimize vulnerabilities to counterfeit drugs.

It is also important that we rapidly receive and are able to disseminate information on counterfeit drug introductions when they do occur. As I said, the number of cases of counterfeiting is on the increase, and an important part of an effective anti-counterfeiting strategy is to be able to identify and limit the damage from counterfeit drug introductions when they do occur.

Our task force has recognized the need to strengthen the systems that are used for reporting suspected counterfeits and for alerting stakeholders and the public when these counterfeit drugs do enter the drug supply. So we're interested in hearing about the best approaches and networks and other steps that can be taken to support this important goal of rapid notification and response capability.

It is also essential for consumers, pharmacists, and other health care professionals to know how to identify counterfeit drugs and what to do when they believe that they've encountered a counterfeit drug. This includes recognizing the anti-counterfeiting technologies that are introduced. There are a number of steps in place today for anti-tampering provisions, for legitimate packaging and the like. As I said before, we need to do more, but there are steps that can be taken even now to help recognize when packages, labeling, and the drug products themselves have been compromised.

And while we are already trying to get a message out to consumers and while we've worked closely with pharmacy associations and other health professional groups to get the word out and educate health professionals about these problems, I think there's more that we can do, and our task force is seeking guidance on how best to tailor and deliver these important education messages to help us prevent damage from counterfeit drugs.

Finally, counterfeit drugs are a global problem. We're seeing an increasing number of cases that involve not just a few people manufacturing a fake product in their garage, but well-organized international criminal operations that are trying to make use of the latest technologies for making a product that looks like the real thing but isn't. And we need help of international law enforcement, health and regulatory authorities, as well as private stakeholders internationally to help us address this problem effectively.

So we want to hear about new and better ways to work with other nations to deal with this global threat to the security of prescription drugs.

To all of you who are participating, I want to thank you for your contribution to dealing with this significant emerging public health threat. I am confident that working together we can stay ahead of those who are out to make a fast buck at the expense of the health of Americans. And I'm sure that we will be able to work together to keep our drug supply safe and secure and the safest in the world if we do remain vigilant through steps like this.

Thank you all for your contributions.

[Applause.]

COMMISSIONER McCLELLAN: Maybe if there are a few questions for me--there are a lot of other people here who are more knowledgeable than I am on all of the intricacies of counterfeit drug technology and response systems, but if there are a few questions from press or others for me, I'd be happy to take them right now.

QUESTION: Can you talk about the role of--[inaudible, off mike].

COMMISSIONER McCLELLAN: Well, our main focus here today is on counterfeit drugs. Importation is a different problem. Many of the steps that we are identifying here to take involving counterfeit drugs are over parts of the drug supply where we have authorities and resources to deal with them. Drugs that Congress has deemed illegal are ones that are outside of the scope of our regulatory system, where we don't have any legal authorities, for example, to go into other countries and determine whether these products are safe, and we don't have the resources to back that up either. So that's a different kind of problem, and I'm certainly concerned about any threats to the integrity of our drug distribution system. But our focus here is on anti-counterfeiting steps that we can take when we've got the resources and authorities to deal with the problem.

Yes?

QUESTION: Can you comment on how you see the balance between private sector action on this issue and FDA regulatory action?

COMMISSIONER McCLELLAN: I think it's a combined effort. You know, we do have a primarily private prescription drug manufacturing and distribution system, and that has many advantages in flexibility and competition and the like. It does mean that any of our efforts need to be coordinated well and need to take account of responses that the private sector can take as well.

As part of our task force activities, for example, we're working on model secure business practices that could be adopted by each and every component of the private drug manufacturing and distribution system. We're looking at steps that states have taken through their regulation of wholesalers and distributors that might help contribute to making the drug supply more secure as well. And we're also looking at steps that we can take through regulatory action or identifying solutions that could be widely adopted on a voluntary basis to address the problem.

One of the main points of having this task force effort is this is a big problem with a lot of good ideas to help us deal with the problem, and we want to make sure that we're getting full input from the private sector, from our partners, and government law enforcement and anybody else who's interested in coming up with the best combination of solutions. But it is going to be a private-public joint effort.

QUESTION: Dr. McClellan, is there any kind of estimated time where you think that all of these things could be coming together and that there would be something in place that would be a measure or--I think you know where I am--you know, some sense of, yes, now we've solved the--or we've treated or we've stopped the major problem.

COMMISSIONER McCLELLAN: That we've addressed the problem.

QUESTION: Right.

COMMISSIONER McCLELLAN: We are trying to move as quickly as possible, and I am expecting a final report from our Anti-Counterfeiting Task Force in January. So this is a very fast-track, high-priority effort from the agency, and I'm hoping--I know it's a lot of work for the guys who are involved in this effort, but I'm hoping that that is going to lay out a fairly comprehensive set of ideas on steps that we can take on all of these fronts that I mentioned--technology, response networks, new business practices, and the like--to help address the problem.

But one of the things that has been made very clear to me by both the sophistication of the counterfeit operations that we're seeing and by the expertise that groups like the Secret Service and the Bureau of Engraving and Printing have shared with us is that this is never a problem that's over; that we need to be taking steps constantly to review what the counterfeiters are capable of, constantly review what new steps we can adopt, what new technologies, other new approaches may be available to respond to the latest threats, and keep ahead of the game.

This is a problem that requires a multiple-layer approach, and it requires constant vigilance to make sure that we're staying ahead of some increasingly sophisticated criminals.

QUESTION: Would there be a time when the anti-counterfeiting measures were good enough that you could allow or feel more comfortable with importation from other countries?

COMMISSIONER McCLELLAN: I think that's certainly possible. I mean, there are technologies out there that may one day make it possible to do, for example, reliable tracking and tracing and have embedded in the product, and not just in the package, technologies that are two steps ahead of the increasingly sophisticated counterfeiters that we're facing.

That day is not here now. Many of the technologies that we're hearing about are still in development, and one of the main purposes of this meeting and of our whole anti-counterfeiting effort is to speed up the development of more effective, automatic, reliable, inexpensive approaches to assure drug safety, both domestically and abroad. But we're not there yet. It's going to take some real work in the months and years ahead.

Yes?

QUESTION: Do you have a handle, Dr. McClellan, on what percentage of the drug supply is--how big a problem this really is? And what leads you to say that this is a growing problem?

COMMISSIONER McCLELLAN: Yes, I want to be very clear about that. You know, people in this country have traditionally enjoyed the benefits of being able to walk into a pharmacy and be very confident that the drug that they're getting is the real thing, it is going to work as intended, it's a legitimate product. That has not changed. Our drug supply itself, when you buy within the regulated FDA-, state-regulated system, is very safe and very secure, and only a tiny fraction of drugs in that system are not legitimate, are counterfeit agents.

However, there are growing threats to the security of that system. As I mentioned, we are engaged in an increased number of investigations reflecting increased criminal interest here. It's not surprising to me. I mean, criminals are going to go where the money is, and they're also going to go where the technological opportunities permit them to go. So there are well-financed operations that are investing in better technologies because they can make a fast buck, they think, at the expense of the public health. That's why we need to stay vigilant. The game is changing, and we want to stay ahead of it so that our drug supply does remain safe and secure.

QUESTION: Is there any evidence [inaudible].

COMMISSIONER McCLELLAN: Well, the growing number of investigations reflects a growing number of criminal operations involved in counterfeit drug production and distribution. And as I said, we're seeing more operations that aren't just a few people, you know, working together locally but multiple locations, well connected via the Internet and other communications means, financed well enough to develop and implement technologies that look a lot like the real drug products. We're seeing this on an increasing scale. There have been a number of high-profile investigations just this year that have gotten a lot of public attention in this regard.

Now, that doesn't mean that people who are buying drugs--you know, who walk in the pharmacy and buy a drug need to have a real worry that those drug products are safe and secure. Again, the chance of any particular drug people who buy within the U.S.-regulated system is illegitimate is extremely small. But we've got to be vigilant to keep it that way. There are more criminals that are better organized with better technologies, better abilities to communicate, who are out to make a buck this way. And I want to keep our drug supply secure. We owe that to the American public.

I think I have time for one more. Yes?

QUESTION: [inaudible, off mike.]

COMMISSIONER McCLELLAN: Well, the PDMA did view having a drug pedigree as one important step towards assuring the security of the drug supply. There's no question about it. If we could have reliable, you know, with no possibility of fraud, methods of making sure that a drug can be tracked reliably and can be traced back if there is a potential problem, that would add immensely to our ability to secure the drug supply.

Congress, though it passed the law, has also expressed some strong concerns to us about the feasibility of implementing the PDMA as written. And as you said, this was a law written 15 years ago in a different era of both counterfeiting technology and anti-counterfeiting technology. It envisioned paper records and so forth, and it didn't even extend to all parts of--the requirements didn't even extend to all parts of the drug distribution system.

In contrast, today we have the potential, perhaps in the next few years, to come up with an electronic version of dealing with this problem more cheaply, more reliably, more securely in a way that can't be faked, like paper records. And so I think there is a new--you know, in this near era there's new, some potentially valuable opportunities for addressing the problems that PDMA intended to solve. Those are serious problems that need to be addressed.

Okay. Thank you all very much again for coming.

[Applause.]

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