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Ensuring the Safety of America's Drug Supply
Scott Gottlieb, MD
Deputy Commissioner for Medical and Scientific
Affairs
Food and Drug Administration
This updates a previous version of this speech posted earlier on Sept. 20, 2005.
This text contains Dr. Gottlieb's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.
At FDA, the growing prevalence of counterfeit drugs, and the growing sophistication of those who make their trade in this illegal business, worries Commissioner Crawford and all of us a great deal.
There is no question that these problems, and the flow of counterfeit drugs around the world, are mounting.
But on the whole, 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.
Studies by the World Health Organization have shown that of developed markets, this is especially true in Europe, where parallel trade has created porous borders and permeable controls that leave many opportunities for counterfeit drugs to enter Europe's supply chain.
This is especially true for drugs taken to treat chronic conditions such as high blood pressure or high cholesterol, which seem to be among the preferred targets of the counterfeiters.
These counterfeit drugs may be contaminated or may not work as intended, and that's a real public health concern.
And although the counterfeiting of drugs is still not as widespread in this country, we have seen a significant increase in counterfeiting activities around the world.
And even more worrisome, we have seen an increase in the sophistication, the cleverness, and the technical capabilities of counterfeiters that are trying to get drugs into the U.S. distribution system.
In 2000 FDA opened 6 counterfeit drug cases, in 2003 we opened 30, and last year we opened 58.
This increased enforcement activity is not only a function of the fact that we are looking harder for these problems. But also, that we are finding many more of these problems crossing our desks during our routine, daily work.
Just this past month, on August 31st, we busted up a Lipitor counterfeiting and smuggling operation that was trafficking almost $50 million worth of the drug.
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 risk 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 -- but that the counterfeit versions cannot.
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.
One of our proposed remedies at FDA is to strengthen our system for tracking drugs from the assembly line and right to the patient's bedside, by replacing the paperwork that now certifies the integrity of a pill with an electronic track and trace system that cannot be easily forged or forgotten.
This can be technology as miniscule microchips or "taggants" that go inside pill bottles, or even inside the individual pills. There's been considerable progress made in developing and deploying these sorts of technological tools.
Right now, we have given manufacturers more time to deploy this kind of technology. We have also put a stay on a rule that would effectively require these kinds of measures, a paper pedigree rule, to give people more time to move from paper pedigrees which would not provide the same kinds of protections to electronic pedigrees, which would. New technology would allow for less costly compliance, and better controls. The rule is written broadly enough so that electronic track and trace could be used in place of paper pedigree. We plan to make a decision soon on this stay, which is in place until December 2006, and we could reach a decision before that.
There are already many promising technologies out there such as 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, whether it comes from a legitimate source and has not been tampered with along the supply chain.
We've seen new technologies for packaging, new color-based technologies that embed multiple different layers of protection.
We've seen new anti-tampering technologies for drug packaging. Even the tops of injectable drugs that can help keep the product secure.
And we'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.
These tools 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 there are 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 drug sector is behind other industries where secure track and trace approaches and secure anti-counterfeiting technologies have become more widespread.
That needs to change, and it is changing.
These technologies together constitute what we call an electronic pedigree, and we believe that these would go a long way toward starting to meet many of the modern needs of the Prescription Drug Marketing Act, the principal law in this country that protects our domestic drug supply from dangerous foreign imports.
In fact, this law was passed in part, in direct response to a widely reported case where counterfeit drugs that were sub-potent made their way into the U.S. drug supply. But that was a long time ago, the counterfeit drug problem has grown much worse, and so our tools for dealing with it need to advance as well.
Many people believe that FDA interprets our counterfeit drug report that we issued to address this growing threat as saying that we want RFID implemented by 2007. We said that an electronic pedigree should be feasible by 2007, and right now, RFID is the most promising technology to help deliver on that need.
We believe that we can accelerate the 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 some of these technologies do seem just a short time away from widespread
application, others have not been fully developed yet and demonstrated to be
feasible. We will continue to work with the private sector to foster advances
in this field.
But as our colleagues at other agencies 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.
In short, we need 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 build more safety and security in prescription drugs as well, and we're going to be working to bring forward proven technologies, and to develop the proof for these other technologies.
We need to bring them forward to improving our drug supply as quickly as possible.
But no one technology is going to assure safety and security. So we need to maintain vigilance over our entire drug chain.
So certainly, this is not a time when we should be going in the exact opposite direction, and weakening the controls we already have over our domestic drug supply.
We need to be adding further measures to ensure the integrity of the supply of vital medicines, not dismantling the measures that we already rely on.
For this reason, it is hard to have a discussion about counterfeiting without also addressing, at least in part, proposals that would increase or legitimize widespread importation of foreign drugs.
These kinds of policy proposals mean many different things to the many people that have grappled over this issue over the last five years or more.
But simply put, for the professional staff at FDA that is charged with ensuring the safety of our drug supply chain, in means one thing above all else:
The importation of foreign drugs through middlemen, through storefront pharmacies, and through foreign websites, represents a new and gaping hole in our controls over our drug supply. These holes are already being exploited by those up to no good.
And no amount of well intentioned legislation, to apply a safe way to check the drugs coming in through these different importation schemes, is going to fully guarantee their safety.
All of these schemes are going to weaken our controls, some more than others. And so any consideration of importation needs to come down to a question of how much safety you want to demand, and how many corners you are willing to cut.
And one more thing: These importation schemes are utterly inconsistent with many of FDA's fundamental goals and its fundamental practices.
The same regulatory agency that is called upon to tease apart subtle distinctions about hard to measure risks inherent in certain drugs in one room, is being asked by some to go into another room and open up big holes in the controls over the kinds of drugs that we allow into the U.S., and not be as worried that many of these imported drugs may have co-mingled with counterfeits that are contaminated or sub-potent.
The same agency that is asked to work diligently to write well reasoned, careful labels on newly approved drugs identifying all of their risks and benefits in one room, is asked to go into another room and overlook the fact that there are imported foreign drugs coming into this country with the wrong labels on them, with no labels on them, or with labels written in languages other than English.
The same agency that asks drug developers to sponsor ten thousand patient clinical trials to tease apart the preferred dose of a new drug in one division is being asked by some to formulate a separate division that would allow drugs that are in the wrong formulation or the wrong dosage to be imported.
It is hard to imagine being able to maintain all of these kinds of inconsistencies and still sustain the same kinds of controls on safety that people expect and rely on today.
And so asking the question about drug importation and of whether we want to strengthen our grip over the drug supply in the face of rising counterfeiting or weaken those controls in the name of price considerations is also asking a fundamental question about what we want out of our drug regulatory agency.
These are fundamentally difficult questions, and many people are rightly concerned about the high prices on many drugs, especially people who can least afford to pay for medicines because they lack good health insurance, or have no insurance at all.
And many people are rightly angry about the lower prices that drugs cost in many foreign nations because those countries impose strict controls on the prices that U.S. and other manufacturers can charge for their products overseas.
And so, at FDA and across the government, we are also continuing to champion safe ways to lower drug costs through expanded coverage offered by the new Medicare prescription drug benefit, through more steps to make OTC drugs available, through more steps to lower the cost of bringing safe and effective new drugs to the market and to develop information that guides their smart and appropriate use, and through more steps to allow people to make wider use of safe and effective generic medicines. In fact, Generic drugs represented more than 66 percent of the total prescription doses sold in 2004.
Finally, and in closing, we know that we cannot solve the counterfeit drug problem working alone.
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 so we need help of international law enforcement, health and regulatory authorities, as well as private stakeholders internationally to help us address this problem effectively.
We cannot just secure our borders and turn our head to the larger problems that are occurring elsewhere.
So we have consulted with regulatory authorities around the world from Taiwan to Morocco to Malaysia, China, and Sub-Saharan Africa. We continue to build these relationships.
We are also working very closely with Interpol and various law enforcement entities in various countries on specific cases, as well as the World Health Organization on a broader strategy to address the global problem. The WHO had a meeting last year with drug regulatory authorities and we expect to meet again in the coming months.
To those of you who are working on ways to combat the growing traffic in counterfeit drugs, at FDA we want to thank you for your contribution to dealing with this significant emerging public health threat.
At FDA, we are 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 we are 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.
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