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Mark B McClellan, MD, Ph.D. - National Press Club

This text contains Dr. McClellan's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Speech before
Fifth Annual David A. Winston Lecture

National Press Club
Washington, D.C.

Remarks by
Mark B McClellan, MD, Ph.D.
Commissioner, Food and Drug Administration

October 20, 2003

Good evening and thank you for your kind words. It’s an honor to be here tonight, and to be able to pay tribute to someone who dedicated so much of his life to helping others improve their health.

I didn’t know David Winston personally, but I certainly know his legacy, and I think his impact came on two levels. First, by what he was able to accomplish. For example, as president of the National Committee for Quality Health Care, he helped set some of the standards through which many people came to enjoy higher quality healthcare – perhaps not a glamorous achievement, but an essential one for identifying and encouraging best medical practices. And second, by the seriousness and effectiveness with which he approached health policy problems. He set an example for all of us in how to find solutions for difficult health care problems. President Reagan would later say of David that he was “the kind of person who made a tremendous contribution by working largely behind the scenes, but those who knew him were keenly aware of his central role."

Biomedical technology has advanced dramatically since then, and the details of the healthcare policy debates have changed along with medicine. But some of the most pressing healthcare problems remain the same as when David was working to advance the health of the public. The mark of good leadership is finding ways to achieve the often-competing goals in health policy, to get the best care to the most people to achieve the greatest improvements in public health. Even though we all want simple and fair solutions, it’s not easy to get there. But real leadership like that which David Winston provided is more important today than ever.

And that brings me to my main topic. A lot of public attention has focused on drug importation recently. It’s easy to understand why: people walking into a pharmacy and paying “list price” are facing much higher prices for brand-name drugs in the United States than in Canada, France, or any other country for that matter. Americans now pay about half of all costs of prescription drugs worldwide, even though we account for a much smaller share of the prescription drug use around the world. For many Americans who are left on their own when it comes to prescription drugs, who don’t have good coverage and who receive little or no assistance in getting lower prices, the only alternative to high prices here seems to be buying cheap medicines outside this country. And more and more people are finding themselves with no other alternatives.

When it comes to buying drugs internationally, outside of our regulatory protections, beyond the authorities of the Federal and state watchdogs for drug safety, FDA has consistently said for many years that we can’t in good faith endorse “buyer beware” approaches to the problem of affordable drugs. Buying long distance from sources we can’t regulate is simply not the same as walking into a well-regulated pharmacy under the regulatory umbrella of Canada or another country with a very safe drug supply. People’s health is put at risk when doctors and pharmacists, our “learned” intermediaries, are replaced by store fronts and bogus Internet sites that are there for private profit not public health.

Consequently, when Americans import drugs that are not regulated and approved in the United States, it presents real safety risks, risks that are becoming more common. For example, we recently reported on a “blitz” at four airports over three days, conducted with our border enforcement partners at the Bureau of Customs and Border Protection. We identified more than eleven hundred unapproved drugs coming in from Canada, and many drugs that because of labeling, storage, or other problems presented real safety risks.

This debate about safety versus affordability makes people angry, and it should. Most Americans do not understand why Canadians can get many drugs that are very similar to those available here safely and at a lower price than in the United States, yet the United States hasn’t found a way to provide drugs that are affordable and safe in our own country. And until we find solutions that do not force Americans to make choices between safety and affordability, all of us involved in policy cannot rest. That’s why we’re working harder than ever to do what we can with the authorities we have at FDA, and that’s why we need effective action from Congress now to improve both drug affordability and drug safety.

So that’s what I’d like to talk about: finding ways to keep prescription drugs safe and secure, while making them more affordable. This evening I’d like to accomplish three things: (1) set forth the serious problems facing the safety and security of our drug supply today – which helps make clear why we need to improve the protections for our drug supply, not weaken them; (2) explain why legislative proposals that essentially assume that drug imports are safe doesn’t make them so; and (3) describe how FDA is working on a better path forward to help ensure that Americans have a prescription drug supply that is both safe and affordable – and how we need help to achieve this goal.

Why are FDA and our partners in law enforcement and in state regulation of drugs so concerned about having the authorities and resources we need to assure the safety of drugs produced and imported legally into this country? Because a safe and secure drug supply is so valuable to all Americans. Sixty-five years ago, Congress responded to widespread fears of unsafe and ineffective domestic drugs by directing FDA to create a system for assuring that Americans have a drug supply they can trust. Fifteen years ago, Congress responded to serious safety problems created by imported drugs that were not tightly regulated by passing the Prescription Drug Marketing Act. Congress did this because of the importation of significant volumes of adulterated and counterfeit drugs, along with legitimate reimported drugs. I’ll give you just two examples of what was going on in 1985 before PDMA became the law. First, over 2 million unapproved and potentially unsafe and ineffective Ovulen-21 tablets originally from Panama were widely distributed throughout the U.S. Similarly, a counterfeit version of Ceclor, an antibiotic widely used at that time, found its way into the U.S. drug distribution from a foreign source.

Over the years, our professional staff has used these authorities to build a drug safety infrastructure that gives our citizens the highest-quality drug supply in the world. Unfortunately, the drug supply that we have worked so hard to protect is under unprecedented attack from a variety of increasingly sophisticated threats. There are many reasons for these threats. A lot of money at stake with today’s prescription drugs, and to paraphrase Willie Sutton, people who want to make a fast buck are going to go where the money is. The technologies for getting questionable drugs to patients have improved across the board, everything from pill molding and dyes for counterfeiters to easy Internet access for anyone who wants to set up a web operation. The result: more than ever before, well-organized criminals stand ready to exploit any crack in our regulatory system to profit at the expense of public health.

This is evident in the recent significant increase in sophisticated efforts to introduce counterfeit drugs into the U.S. market. FDA has seen its number of counterfeit drug investigations increase four-fold since the late 1990s. Although counterfeiting was once a rare event, we are increasingly seeing large supplies of counterfeit versions of finished drugs being manufactured and distributed by well funded and elaborately organized criminal networks. FDA has long been concerned about this growing problem. But because there now appear to be a range of new technologies, regulatory and enforcement activities, and other opportunities to help address it before it gets worse, last July I launched a special task force to head off this growing threat to drug safety.

At the same time, inadequately regulated foreign internet sites have also become major portals for unsafe and illegal drugs. For example, the nature of the drug abuse problem is changing in the U.S., and the growing availability of prescription narcotics over the Internet is a principal contributor. We are working closely with our colleagues in the Drug Enforcement Administration on new approaches to meet this new challenge to drug security. We must not allow the Internet to become the 21st century’s virtual drug cartel.

With all of these new threats, Congress must make sure FDA has the resources and authorities it needs to keep our drug supply secure. Yet the debate in Congress has mainly been about taking away from our existing authorities, and simply declaring more non-FDA approved imported drugs to be legal. I think Congress recognizes that the world has changed, there are more security concerns than ever, and so our vigilance over imports that enter this country must change as well. Just last year, Congress passed legislation that will give us an unprecedented ability to protect our food imports from deliberate or accidental attempts to contaminate them. As a result of this legislation, FDA has boosted its food security activities at the border substantially, with literally hundreds of new inspectors and support staff. And that staff is backed up with new legal authorities: for the first time, we will be notified of essentially all commercial food shipments ahead of time to allow us to target our efforts to the riskiest products, before they enter the country. So thanks to Congress, we have new abilities to take action to prevent the entry of foods that may be unsafe.

But with respect to drugs, some in Congress want to go in the opposite direction. All the evidence suggests that it is not safe to simply declare broad new classes of drugs to be “legal” and to open up our borders – that many more unsafe drugs would take advantage of wide new “legal” import channels.

You can bet that the same kinds of individuals who are trying hard to exploit weaknesses in our drug security system today will make the most of any new paths that are opened up into America’s drug supply. They are trying now. For example, a consumer recently purchased Neurontin, an FDA-approved anti-seizure medication, from a website that claimed to operate in Canada and ship FDA-approved drugs from Canada to the U.S. However, the drug the consumer actually received was made in India and unapproved for any use in the United States. Pharmaceutical peddlers are taking advantage of regulatory gaps to move millions of prescription drugs including controlled substances into the United States from Mexico, Canada, and elsewhere. Rogue medical merchants who have dubious or no medical background are selling potentially dangerous drugs to people who never see the prescribing doctor in person or undergo tests. At a minimum, these drugs are of unclear origins and safety. At worst, they are improperly repackaged, stored, and labeled, or are out and out fakes.

And I don’t think it’s appropriate for the Federal and state governments to try to foist off the responsibilities for a safe and affordable drug supply for Americans on the government of a country that is a tenth of our own size. Not surprisingly, the Canadian government itself has said repeatedly that it cannot assure the safety of drugs exported to the U.S., even though it is diligent in assuring the safety of drugs purchased through legal channels in Canadian pharmacies.

Buying between the U.S. and Canadian systems is not the same thing as buying within each system. The U.S. and Canada do not have integrated systems for taking timely action to protect consumers in the event of a safety problem involving an illegally imported drug in the U.S. Protections to assure the appropriateness of a prescription, such as requirements for physician contact and monitoring, may differ. And each country has only limited resources to devote to their existing systems for assuring drug safety for their own populations, let alone to assuring the safety of an expanded scope and volume of drug imports. For example, Ontario, Canada’s largest province and one of the provinces that purportedly is shipping a large volume of prescription drugs into the United States, has exactly one investigator tasked with policing all pharmacy operations there, including both domestic Canadian pharmacies and the growing number of pharmacies serving only or primarily international Internet customers.

Some people have said: well, maybe it doesn’t meet the standards of a legal prescription in the United States or in Canada, but it’s cheaper, so it’s up to the patient to make sure they use the drug right – to count up the pills, to keep track of the warnings, to make sure the product’s not expired, and so on. Now, I do think it’s important for patients to be active partners in their health care. But an active partnership is a long way from this sort of “buyer beware” situation.

This kind of approach to laying open the U.S. border is embodied in H.R. 2724 (the “Gutknecht bill”) and similar bills. I’ve had a number of discussions recently with some of the supporters of these bills, including Mr. Gutknecht, people who care deeply about the issue of drug pricing. These representatives are clearly in touch with the anger of many Americans especially seniors who simply can’t afford the best and latest prescription drugs. And Congress should do something about that. But at the same time, these members are out of touch with the realities of keeping our drug supply safe, and the clear and present dangers to America’s drug supply that their bills would create.

To give you one example: what is their “solution” to the large and growing pressure of counterfeit, unsafe, and unregulated drugs whose makers would be delighted to see new channels into the United States? An optical anti-counterfeiting symbol on the drug package. Now, although this technology has not been widely evaluated for prescription drugs and would cost billions of dollars to add to drug packages, it is one of a whole set of anti-counterfeiting measures used on our paper money – or rather, that was used until recently, since the U.S. Treasury recently decided that such measures are inadequate to prevent counterfeiting. Counterfeiters today use special inks to produce near-perfect copies; they can crack just about any optical anticounterfeiting technology in less than a year. And so the US Treasury has adopted multiple new technologies.

With drugs, much more than money is at stake. An imprint on a box is no substitute for a comprehensive, multi-part system for assuring the safety of the actual drug product – not the package – all the way from production to patient. We’ve already seen examples of why a focus on labels alone is not sufficient: criminals have repackaged unsafe or counterfeit or different drugs into a legitimate appearing package, for example with Serostim, Procrit, and Lipitor.

We have been working hard recently at FDA on anti-counterfeiting technologies, including at a widely attended public meeting last week. And while there isn’t any magic bullet available today, there are many promising technologies in development. We need them, because as any counterfeit expert in our Bureau of Engraving and Printing or the Secret Service can tell you, or as any of the growing number of drug counterfeiters themselves can tell you, any single anti-counterfeiting technology is essentially useless. Multiple anti-counterfeiting steps are needed to stay ahead. But these technologies have not yet been demonstrated and proven for prescription drugs. And while we need to start doing so right away, an effective anticounterfeiting system to assure the integrity of our drug supply is still a ways off.

The bill may permit some more imported drugs from Canada to come in – although many are already coming in today, and it’s not clear how many more legitimate drugs can be supported through Canada’s much smaller drug supply. But the bill isn’t really about improving our ability to get safe and affordable drugs to Americans – that’s simply not what the bill says.

Instead, what the bill actually does is take away FDA’s existing authorities to protect Americans from unsafe imports, authorities that are already being stretched. It would create unprecedented prohibitions on FDA’s ability to inspect and test drugs, and FDA’s ability to block the distribution of drugs we think are unsafe. And it provides no clear new resources to handle the flow of potentially unsafe imported drugs into the United States, a flow that could become far larger than it is today. So, in addition to allowing in some drugs that might be safe, it would also create wide and poorly-regulated channels through which a lot of potentially unsafe drugs will also be able to enter the country more easily.

In addition, the bill does nothing to stop the dangerous proliferation of uncontrolled, unlicensed, and unregulated Internet web sites selling potent drugs without proper medical oversight – in many cases without the oversight of any kind of health professional whatsoever. So the bill provides new opportunities to harm Americans for great profit, and does nothing about the range of 21st century Internet-based weapons available to criminals to carry out that harm.

This is not the time to be opening up new avenues for those willing and able to harm patients for their own gain. By choosing affordability over safety rather than taking new steps to address both, this legislation is a dangerous solution to our twin challenges of safety and affordability.

Instead, we need legislation that is in touch with the realities of both making drugs affordable and making them safe. In the real world, as any of our dedicated field investigators can tell you, as any pharmacy regulator can tell you, and as all the major health professional organizations have said, just because a bill says drugs are safe doesn’t make them so. I believe that we can do much better. I believe it is possible to pass legislation to keep our drug supply secure while improving access to affordable drugs, and I hope that Congress will continue to work with us to do so. And based on everything I’ve seen so far, I’m not optimistic that drug importation can be a durable and widely-available solution to the problem of safe and affordable drugs. Other steps are needed.

On this issue of legislation to allow importation, the AARP has made some good points recently. AARP correctly pointed out that the way drugs are priced around the world is unfair to millions of Americans, and that something should be done about it. And they also pointed out that, in order to keep our drug supply safe, any such legislation is going to require more resources and more authorities at FDA, to assure drug safety and integrity of our drug supply with a broader range of drug products. And that’s precisely why the AARP does not support the Gutknecht bill.

Other entities, including some local and state governments, are investigating whether they can improve their own budget picture by entering into formal agreements with storefront operations that purport to be Canadian. All of these endeavors that I’ve heard about create safety problems as well, for many of the same reasons. Much as they would like to, state and local governments and private groups cannot provide reliable safety assurances when they purchase drugs from foreign sources. It’s simply not enough to replace a comprehensive Federal and state system for assuring drug safety by picking a company operating outside the US that appears to be legitimate and hoping that their drugs turn out to be safe. In spite of what some say, none of these drugs will have gone through the approval, monitoring, and prescribing process required in the United States. I know these governments are facing tight budgets and have to make hard choices. But I don’t think they should settle for taking an uncertain gamble on patient safety just to save money.

And the companies they work with, the companies who encourage purchases of imported drugs, aren’t only risking the public health to make some money. By creating significant new international flows of drugs into our system, they may be aiding criminal enterprises that can put all Americans at risk by complicating our job of protecting the borders. One thing should be very clear: opening America’s borders to imported drugs would certainly not help protect our pharmaceutical supply against bogus drugs, and it would very likely make a growing problem worse.

Worst of all, it’s not even clear that expanding access to such imported drugs will ultimately provide access to more low-priced, reliable drugs. If expanded importation into the United States threatens the much smaller supply of drugs in Canada or France or elsewhere, then it’s possible they will take steps to restrict such imports to the United States. The result: a big step back on the security of the US drug supply as the pressures for unsafe imports from other sources increase still further; worsened relations with countries that we need to have working together with us to make drugs more affordable; and little or no progress despite all this effort on making drugs more affordable in the United States. After waiting far, far too long for access to drug coverage and more affordable drugs, Americans deserve better than an approach that’s likely to fail.

I’ve tried to be very clear about what we’re against. We’re against large new gaps in the nation’s ability to protect its citizens from potentially unsafe drugs, at a time when the threats to the safety of our drug supply are greater than ever. Now let me add to what I’ve said about what we’re for. There are better ways to provide access to safe and affordable drugs that are the most innovative in the world. And no question, we need help from Congress not just in drug coverage but in keeping our drug supply secure, in continuing that 65-year tradition that has been so important to the high level of confidence that Americans can have in their legal prescription drugs.

First, FDA and our partners in regulating prescription drugs must have adequate authorities and responsible private-sector partners in assure drug safety. Over time, it may be possible to assure drug safety through a multilayered strategy of modern anticounterfeiting technologies, including “track and trace” technologies that cannot be faked like a paper drug pedigree, and verification technologies built not only into tamper-resistant drug packaging but into the drugs themselves – including both technologies that consumers could recognize as well as covert technologies that would not be easily known to counterfeiters which could make our job of verifying the legitimacy of drug products much easier. We are already working hard on speeding up the availability of these anticounterfeiting technologies, which currently are months to some years away.

In the meantime, FDA needs all of the authorities it has now to assure the safety of legal prescription drugs. This includes the ability to require or conduct tests of product authenticity and potency; the ability to identify and when necessary inspect those involved in the distribution of pharmaceuticals; and the authority to issue regulations and when necessary take decisive action to block the distribution of potentially unsafe drugs. It’s certainly not the time to weaken these authorities, or to allow products into this country that are not subject to these consumer protections, as many of the importation bills being considered by Congress would do.

We also need to make sure that everyone involved in getting prescription drugs from the manufacturer to the patient follows good drug security practices, to prevent potentially unsafe drugs from entering our drug supply. There are concerning weaknesses now. FDA has worked closely with states such as Florida that have recently taken important steps to assure good business practices and to address security gaps among drug wholesalers and distributors. This is particularly important for certain so-called “secondary” wholesalers, which have historically been the source of introducing many unsafe drugs. But the same problems arise with any poorly-regulated organization involved in getting drugs to patients, including storefront operations and internet sites that do not have meaningful professional standards but do have the opportunity to take advantage of consumers. As part of our task force activities, we are working on a model code of business conduct that we will then work to get widely adopted by the prescription drug distribution industry.

Second, we need an adequate ability to monitor the integrity of the prescription drug supply and respond to threats. We are considering further steps, until automatic technologies can take care of it for us, to improve the quality of drug pedigrees without imposing unnecessary costs or new systems that could still be gamed by criminals. We also need enhanced methods to assure the legitimacy of Internet sites and the storefronts that sometimes work with them, and to take fast action against those sites that are not following good medical practices. This is an especially tough problem when it comes to the growing number of sites operating outside the United States, but we must work with other nations to address this global threat. And at a minimum, we need to be extremely careful about adding any additional “legal” distribution points and channels to our drug supply, especially stores or sites with no medical regulatory oversight, unless we have the ability to monitor their integrity.

We also need better methods for identifying and responding to unsafe drugs that make it into our drug distribution system. For unsafe drugs that penetrate our legal system of drug distribution, we need a mechanism for faster and more reliable notification of the FDA and other regulatory authorities from manufacturers, distributors, pharmacists, and consumers when potential problems are identified. And we need a better mechanism for notifying everyone who may be affected when a problem arises. We are working with private-sector partners on an integrated electronic system to do just that. For drugs that are imported outside of the legal approaches for monitoring imports, it’s worth noting that we currently have no reliable or timely way to identify safety problems and cut off the source when a safety problem occurs.

Third, we need to make sure that the scope and volume of the drug products that are deemed to be legal are commensurate with the resources of the FDA and our state partners to assure their safety. Our current resources are being stretched thin, especially at the border, which is an important line of defense against potentially dangerous drugs shipped from other countries. This is one reason why Congress made many drug imports illegal in the first place: FDA did not have the resources or authorities to assure their safety, and still doesn’t. The safety risks of some drugs are especially great; for example, in recent years, we have seen many more drugs that require “risk management” programs of tight monitoring, biologic and injectable drugs that have especially complex manufacturing and storage requirements, and controlled substances.

I believe that by adhering to these principles, we can maintain an up to date drug supply that is safe and secure, despite the increasingly sophisticated and diverse threats to the safety and integrity of our drug supply. The FDA is working harder than ever to achieve these goals, through our new task force initiatives and new collaborations with other government agencies, the private sector, and other governments. I hope that Congress will help, not hinder, the efforts to meet these unprecedented challenges.

We also need a better, global solution to the problem of affordable drug pricing. It is not fair that countries with almost as much ability to pay as the United States are in many cases paying prices much lower than those in many less-developed nations like Poland. This is not a trade issue, where one country benefits if another country pays more. It’s a global public health issue, since the drugs we are buying today and the drugs in development for the future hold the potential to improve health around the world. If all countries pay their fair share, prices can be more affordable for everyone. If all countries keep working apart in our own interest to just pay the incremental cost of making a few more pills, none of us will end up benefiting.

FDA is also taking many other unprecedented actions designed to get more affordable drugs to Americans, wherever we can without compromising safety. We are taking steps to lower drug costs by helping to speed the development and approval of low-cost generic drugs after legitimate patents have expired on branded drugs. This includes the biggest expansion ever of our generic drug program, and a series of regulatory changes to make it easier for generic manufacturers to compete. We’ve taken steps to help improve the development process to help lower the high cost of developing new drugs. We’ve taken steps to improve the process by which drugs are manufactured. We’re working to prevent adverse events through new rules that would require bar coding for drugs and better ways to track adverse events automatically – with the goal of preventing billions of dollars in unnecessary health care costs each year. We’re striving to promote electronic prescribing, to improve quality and reduce prescription costs as well. And we’re taking other steps to provide better information to health care professionals and patients alike, including new and better electronic product labels and Internet-based information, about the risks and benefits of medication choices available to treat a particular health problem.

Of course, the most important step the government itself can take to solve the problem of safe and affordable drugs extends beyond FDA. It requires legislation that the President and bipartisan members of Congress are closer than ever to achieving. It is time for Congress to pass overdue legislation that would improve Medicare by making safe and effective drugs more affordable for seniors. Such legislation would cut drug costs for seniors by many billions of dollars each year, and would enable seniors to band together to reduce their drug prices substantially.

And so I firmly believe that we can and should do a much better job of making safe and innovative drugs affordable in the United States. But we need to work together to do so, and on all of these issues I want to pledge FDA’s continued assistance for anyone in Congress or elsewhere who wants to work together to find safe and affordable solutions. David Winston’s legacy shows us all that there can be effective solutions to these kinds of problems if we work hard and work together. A cheap drug isn’t a bargain if it puts your health at risk. We owe it to the American people to find durable solutions that will not create risks to their health. We owe it to the American people to make sure they can enjoy the benefits of new safe and effective medical technology, and that they can meet their medication needs affordably. Thank you.