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Mark B. McClellan, M.D., Ph.D. - The Urban Institute

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.

"Protecting and Advancing America's Health Through 21st Century Patient Safety"
Speech before the Urban Institute
Mark B. McClellan, M.D., Ph.D.
Commissioner, Food and Drug Administration
November 12, 2003

We are living in a truly remarkable era in science and in medicine. New treatments and products resulting from medical technology are not only achieving breakthroughs in the lab. They are making growing contributions to our economy, our homeland and national defense, and most importantly our public health - helping us live longer and better lives than ever before.

Enabling these safe and effective new medical technologies is a fundamental part of FDA's principal mission - to protect and advance the public's health. But that traditional core mission of public health protection involves unprecedented challenges today.

Principal among these is our responsibility for ensuring the safety of an increasing number of more sophisticated products. Medical products today do far more for patients than ever before. From monoclonal antibodies to injectable drugs to small molecules that mediate complicated cascades of cell signals, the opportunities for making real health gains from better, more effective medicines have increased significantly. But there is no such thing as a completely safe medicine. All drugs carry risks and benefits. And so, while the opportunities for health benefits have gone up with today's more diverse and often more complex medical treatments, there are also opportunities for things to go wrong.

People are taking more complex medicines that sometimes have more subtle or complicated side effects and more people are taking more drugs, increasing the odds that two drugs could have a bad interaction, or may be used incorrectly. And so with all the advances we've made in the last decade, also comes the need to do more to monitor for safety when it comes to using new medicines. We must make sure our efforts to protect consumers keep up with the new technologies.

Unfortunately, even as medical technology has progressed, our systems for assuring the safety of medical treatments have too often remained in the 20th century. And so we are taking new steps to make these systems work better than ever, and to build new ways to assure better patient safety by taking advantage of modern information technology tools.

First, I want to discuss just a few of the improvements we have made on our existing systems. Earlier this year, FDA proposed a comprehensive new regulation for companies to report drug adverse events. This system is designed to get more extensive and timely information where we need it most, for new drugs, important complications, and adverse events that are not well understood. And it was designed with international input, with the goal of creating one worldwide standard that regulatory agencies could use to get the best information possible on adverse events, and at a lower cost.

We've also upgraded our systems for collecting and analyzing adverse event information, including easier, web-based reports and systems to make them easier to analyze. Using new authorities from legislation enacted last year, we're also implementing new programs to monitor the safety of new drugs after they're approved. And we've developed new guidances and are implementing new techniques for improved "risk management" programs for prescription drugs that require special steps in order to be used safely. These and other steps mean more safety monitoring and response activities are in place than at any time in FDA's history.

But now that we are well into the Information Age, now that modern information technology has had a fundamental impact on so many parts of our lives, there's no good reason we can't have a fundamentally better system for helping to protect consumers and assure the safe and effective use of new drugs. With the highest health care costs in the world, Americans should not have to tolerate thousands of deaths, millions of hospitalizations, and tens of billions in added health care costs from preventable medical errors. Americans deserve better than settling for serious health consequences, or benefits, that can't be spotted until many years after a product has been on the market. And Americans and their physicians deserve better than having to rely on limited and often outdated information about risks, benefits, and costs of medical treatments when they are making medical decisions - which, these days, are among the costliest and most important decisions in their lives.

In short, Americans deserve a lot more value and up-to-date protections when it comes to their medicines. And if we don't take more steps now to use modern technologies to make that happen - to prevent the errors, to help make sure people who use medicines are getting real health benefits, and avoid complications whenever possible - then we may end up with a very different future: a future not marked by continuing breakthroughs in curing and preventing diseases, because we can no longer afford it; instead, a future marked by rising concerns and rising anger about health care that costs too much to do too little.

With so much at stake -- much needed improvements in the safety and quality of healthcare delivery, the need for better systems for monitoring the risks and benefits of new medical products, and the need to do all of these things in less time and at a lower cost so that more people can benefit from new medical products - we can no longer wait to change our health care system. And today, I want to talk about one part of the needed change that hasn't received the attention it deserves lately: speeding the use of modern information technology to help make medicines safer and more effective, to give people more health benefits for the money they're spending on health care.

Information technology provides remarkable new opportunities to accomplish all of these goals and more. There has been growing recognition of this fact in government, led by Secretary Tommy Thompson's "e-health" efforts. And there's growing recognition in our health care system, as more physicians, hospitals, and health care organizations "go paperless."

But I don't think there's been as much recognition of what all of this means for the areas of greatest concern for FDA's mission: assuring the safety and effectiveness of medical products, and helping to protect and advance the health of the public. Whether it's developing and filing information from clinical trials with the FDA electronically, or prescribing drugs electronically to assure that the right prescription gets to the right patient at a lower cost, or monitoring patient data in real time for signals that approved treatments may be causing potentially serious side effects - all of this can have a fundamental impact on our mission.

And so we are working to take more steps to bring the benefits of modern health information technology to help patients and health professionals get more health benefits, to avoid complications, and to save money. Today, I'm going to talk about some of the new things we are doing, and also some of the further steps we can take right now to make sure that we are using IT tools effectively when it comes to delivering safer, higher value, and less costly medical care. This topic is critical right now, because the Medicare legislation pending before Congress can do much to make this vision a reality. Improving Medicare isn't critical just to get better drug coverage and lower drug prices to seniors - important as that is. It's also critical because it can help us bring these important safety and effectiveness benefits to patients. So for the sake of affordable and safe drugs, and for the sake of a better future with even more valuable medical treatments, we need to work together to get these things done.

One way to think about our mission at FDA with respect to new products in development is the answer to the following question: How can we get the most benefits to the most people from the medicines they use?

This is a hard question for all of us. At FDA, we're worried about the time and the cost to develop high-quality, reliable evidence on the safety and effectiveness of a product for the patients that it's intended to treat. Doctors and patients need this evidence to have confidence when they use a treatment. We often start this process with some expectations, based on in vitro or in silico studies, or animal models, or on other kinds of preliminary evidence from research. But our statutory mandate and the confidence of the American public demands that we cannot approve a product until there is good evidence that it is safe and effective in patients.

And the answer keeps getting more complex, as we continue to learn more about the mechanisms of diseases and their treatments in particular kinds of patients. So everyone involved in product development, and especially at the FDA, needs to work to identify and manage these risks, while finding ways to increase the benefits of a treatment or intervention.

One way to think about all of our work on the safety and effectiveness of medical treatments is to see it as a very complex form of what safety experts call "risk management." At FDA, we are stressing the goal of efficient risk management - finding the least costly approach to achieving the maximum risk reduction for Americans, including both risks of products and risks of the health problems that the medical products are intended to treat.

To achieve the goal of efficient risk management, we work to maximize our ability to identify risks and benefits of products. And we also try to minimize the areas where the linkage between the treatment and its effects for good or ill is hidden or concealed from us.

These efforts start even before we get a new product application, with our oversight of product developers as they test the product in people and develop the evidence needed to show safety and effectiveness. It extends through our regulatory review process for evaluating new treatments, and continues through our oversight of appropriate and up-to-date labeling with information for health professionals and patients about how and why to use them, and through our efforts to monitor and promote the safe and effective use of approved medical products.

I'd like to talk about each these steps today, and how we're working to use better modern tools to make sure that we're doing the best job possible to address all of these challenges. I'll begin where all new drugs begin - with the evaluation of a new drug in a clinical trial.

This process for reviewing new drugs draws on the best and most complete and appropriate medical evidence, the expert judgment of our professional staff, and the specialist advice of patients and doctors on our advisory committees -- to carefully balance the benefits and risks of new medicines. All of our approval decisions come down to decisions about how much risk and uncertainty we're willing to tolerate. In turn, that depends on the strength of the evidence on the benefits that a new drug or medical device will provide.

We are doing more to define risks and benefits of treatments at a lower cost, by working to improve the science around answering these questions. For example, we're undertaking new steps to develop better information about the differences in the way people respond to drugs and the types and dosages of medications that they are most likely to benefit from and least likely to suffer and adverse event.

A key part of this effort is electronic data systems for clinical trials. This morning, I am also announcing another important step toward helping achieve a more robust system for evaluating and tracking the safety and benefits of new drugs. In collaboration with the National Cancer Institute, FDA will be unveiling a system for receiving investigational new drug applications electronically.

These applications, known as INDs, are the first submission that drug developers must file with the FDA in order to receive permission to begin testing a drug in people - to begin the standard "three phases" of clinical trials. Our receipt of these applications electronically, through eINDs, is an important step toward moving the FDA further down the road to a truly electronic system for clinical trials information.

For our part, FDA stands ready to receive these electronic applications right now. And because the submission is quite straightforward, filing an eIND could be as simple as sending a secure e-mail.

This new system will also allow us to review these applications faster and hopefully get new treatments to patients more quickly, and at a lower cost. The process for submitting electronic INDs is part of a much larger effort - the "Cancer Biomedical Informatics Grid" project - that we're working on in cooperation with our partners at the National Cancer Institute. The eventual goal is to have an entirely electronic system for the submission and evaluation of clinical trial information for cancer trials. And our goal at FDA is to eventually use our experience with the NCI as a model for how we manage information across all of the different therapeutic areas and in every clinically trial.

In order to make sure we're making the best use of the information that we generate during clinical trials, it's important that we make as much of this information as possible electronic so that it can be more easily queried, evaluated, and archived. And we believe the NCI can be especially helpful in moving us toward this electronic system -- in part because the universe of cancer doctors and the NCI's cancer cooperative groups have implemented some of the most advanced information systems already.

In many cases, doctors working in the NCI's cooperative groups are already entering this information electronically. And their experience proves that this kind of electronic information not only makes the clinical trial process faster, but also better because more of the important information can be made easily available and queried by drug developers and reviewers here at the FDA.

In the months ahead, we intend to pursue more efforts like these. Our goal is to turn an explosion of information from new biomedical sciences into concrete, practical steps for improving the process of developing and using new medical technologies.

Having more of this information available electronically will allow clinical trials that today would take many months and cost many millions of dollars to be done more quickly and easily. For example, instead of requiring researchers to cull through patient medical files every time new questions arise about a new treatment - all in order to piece together fragments of information scribbled inside paper medical records -- if more of this information was available electronically, these queries could be accomplished at minimal expense and in a matter of minutes.

These systems can be especially helpful for understanding the benefits and risks of drugs better in particular groups of patients - racial and ethnic minorities, women, children, seniors, and others, for whom it can be very hard and very costly to get a large amount of definitive data in any single clinical trial.

Our efforts to move to electronic data in clinical trials complement an announcement last week, which illustrates how important these systems are as we work to move toward an era of more individualized, high-value medicine: a new regulatory approach for using pharmacogenomic information in product development.

Pharmacogenomics deals with the small genetic differences that help define why people respond differently to the same drug. In many cases today, when people have a bad response to a particular medicine, we don't really understand why these differences happen, or which patients are most likely to realize certain benefits.

We believe better analysis of pharmacogenomic data can close these information gaps, and we think the FDA can help. This is information we know product developers want to generate, but may not want to submit to us, because in some cases nobody knows what the results of these analyses really mean. Right now, we have a lot of information about whether drugs affect the activity of thousands of different genes, but we have very little knowledge of how that predicts risks and benefits in individual patients. Thus, product developers may be concerned that such information could raise false flags when its consequences aren't clear, possibly slowing down the review process. But in the long run, the development process is likely to be slowed even more if we are not able to get and use such information to develop better knowledge about predicting risks and benefits.

So we are clarifying when this information will become part of the review process, and when it won't, and we are defining a pathway for submission of this data that will allow us to review it, and learn from it, along with the industry. Developed properly, such information can make our regulatory process more efficient, by helping to predict when a person is likely to benefit or be harmed with various medicines or dosages.

We will take new steps to combine such information submitted electronically to us with the evidence we see on safety and effectiveness of various types of medicines in different patients, to augment the work that is being done in academic labs, medical product companies, and elsewhere to try to turn all of this explosion of biomedical information into useful knowledge for treating patients - greater certainty about which treatments will work, and which will cause side effects, in particular patients. This must be done electronically, using modern electronic information systems, otherwise we simply can't analyze such vast amounts of data effectively. And using systems I'll describe soon, we'll also make our conclusions from such larger-scale data analysis available to doctors and patients everywhere.

So these steps toward developing better, more comprehensive information on treatments at a lower cost are important for reducing the costs and uncertainty of developing new treatments, and they're especially important for patients - so that we can do a better job of telling particular patients about exactly which treatments are best for them.

Of course, this requires making sure we pass along what we learn about medical products effectively to doctors and patients, giving them the best, easiest-to-use, and most up-to-date information possible so they can also make informed decisions. That's why making the best use of the information we receive, and making sure our product labels are comprehensive and easy to use, is so important. We are in the process of developing some fundamental improvements in the medical product label - the information on risks, benefits, use, evidence, and other relevant facts that we review and approve on each product - to bring it into the era of modern information technology. Instead of thin pages with small print in the PDR, the thick book of drug label information that too often sits unused on a physician's shelf, we are revising the label to a format that we can provide electronically and can update regularly.

This structured drug label with start with key risks and benefits, and then will be easily navigable for physicians and others to link in to the risk, benefit, appropriate use, and technical information most relevant to their particular patients. The structure will lend itself to supporting comparisons of the evidence on risks and benefits of drugs in a particular class, or to treat a particular condition. The goal is to help make sure doctors and patients have the latest, FDA-reviewed information on the treatments they might use in a format that helps them make the best decisions possible.

That leads me directly to the next big step forward in monitoring the safety of medical products. After a drug or medical device is approved, FDA's work is far from over. We are spending more effort to be vigilant on how products are being used in clinical practice, to learn more about a product's risks and benefits in actual use. Our goal is to prevent avoidable complications with approved medicines. This includes medical errors, which are far too common. According to a 1999 Institute of Medicine report, 7,000 deaths occur each year as a result of medication errors. Between 1% and 3% of hospital admissions are attributable to medication errors, and the annual cost related to these errors may be as high as $77 billion. Today, errors occur commonly at all stages in the process: when medicines are prescribed, dispensed, and administered.

Earlier this year, we took action on this problem by proposing a new requirement for barcoding of all prescription drugs, biologics, and blood products. Barcoding has been shown to prevent many if not most of the errors that occur at the stages of dispensing and administering medications. And according to many experts, the regulation will speed up the adoption of barcode readers and electronic records, because of the confidence that they can be used with all drugs in the United States.

But I think the most serious errors lie earlier in the process, when the decision is made about prescribing a treatment. For instance, in Massachusetts, the State Board of Pharmacy estimates that 2.4 million prescriptions are filled improperly each year, and 90% of these are a result of either the wrong drug or dosage having been prescribed. And in addition to flat-out errors, there are millions of cases where drugs may be prescribed that may not be the best and the cheapest for a patient, based on the latest medical evidence and the patient's own characteristics and drug coverage. With the explosion of medical knowledge, busy prescribers may be unfamiliar with the best drug or dosage for a particular situation, or unable to get ready access to information about a patient's current and previous medication usage, allergy history, or lab data. In a large inpatient study of preventable adverse drug events, these two "system failures" alone accounted for almost half of all adverse events encountered in the study. Moreover, some of the most widely used drugs in the US have generic equivalents, and many have less expensive therapeutic substitutes that patients might want to consider carefully.

An important way to achieve fewer errors and better drug choices is electronic prescribing. E-prescribing has the potential to eliminate many of the preventable adverse drug events that are related to prescribing errors and to support better-informed decisions about prescriptions. Software packages that support e-prescribing can do things like calculate dosing and alert clinicians about potential side effects and drug-drug interactions or contraindications. And providing information about the risks, benefits, and costs of drugs at the point of care will allow clinicians to prescribe the most appropriate drug for every patient.

This will make possible better decisions about prescription drugs guided by more facts and evidence, right at the point of care. Doctors can potentially have all the relevant information about a new drug and possible alternatives available in their palms every time they make a decision to prescribe a particular drug. And patients could get easier access to information about their drug options as well. These benefits are particularly important to Medicare beneficiaries, who often have multiple coexisting conditions requiring some form of drug therapy.

People have been talking about electronic prescribing for a while, but I think we are fast approaching the time when widespread adoption can be a reality. It's frequently used in hospitals already. And even though well under 10% of prescriptions in doctors' offices are electronic, a multitude of powerful forces - such as the emergence of low-cost Web technologies and the increasing popularity of palm-sized devices amongst physicians -- are converging to modernize ambulatory prescribing as well.

The benefits for our health and our health care spending could be substantial. The Center for Information Technology Leadership estimates that implementing electronic prescribing across the U.S. could eliminate more than 2 million adverse drug events each year, more than 130,000 of which would be life-threatening. At Partners Health-Care in Boston e-prescribing reduced errors by 55%, from 10.7 to 4.9 per 1,000 patient days. Another study of the impact of inpatient e-prescribing on physician prescribing patterns found that compliance with the recommended H-2 blocker jumped from 15.6% to 81.3%, appropriate use of a drug to prevent nausea in cancer patients improved from 6% to 75%, and the appropriate use of prophylactic heparin to prevent blood clots in the lung - a common and dangerous complication of prolonged hospitalization - went from 24% to 47%.

FDA already has a number of initiatives underway to encourage e-prescribing. For example, to ensure that up-to-date drug information will be available to clinicians at the point of care, FDA is developing its new structured medical product labels in conjunction with new standards to make this label fully electronic, through our DailyMed program. The goal is to give the kind of IT-based support systems for good prescribing access to FDA's full, up to date database on the evidence on approved medical product use.

FDA is working with the National Library of Medicine to maintain a comprehensive inventory of these electronic drug labels and will distribute this information free of charge to providers and IT vendors, possibly along with other useful information from medical studies. This will serve as the definitive source of drug information, since it will represent the body of evidence reviewed and approved by FDA.

Although the implementation of e-prescribing has been slow, the Medicare legislation now being considered by Congress can have a huge impact on facilitating adoption. We've been working with Congress to build into the current Medicare legislation new programs and incentives that would help facilitate the adoption of e-prescribing standards and e-prescribing systems. There is strong bipartisan support for this effort, and it's another reason why passing Medicare legislation is so important.

We've been working closely with our sister agencies and with private industry to make e-prescribing standards more widely shared across all of the different information vendors in healthcare. The pilot programs have already been done and the results are in. E-prescribing systems reduce medical errors and they promote savings. Adopting these standards as part of the new Medicare drug benefit would give a huge boost to implementing these systems right now.

We're also working to provide similar information to patients: electronic, up-to-date MedGuides that contain high-quality, useful information to help patients understand how to use their medicines, and what signs of trouble might indicate a reason to contact their doctor. As part of electronic prescribing systems, building on the systems already in place at pharmacies, this information can be provided to patients when they fill their prescription, or at any other time when they are investigating which treatment may be most appropriate.

Of course, the electronic support and information we can provide to doctors and patients are only as good as the available evidence. Even with better systems for improving clinical trial information from the drug approval process, and even with new steps to make this information available to doctors and patients through e-prescribing systems, there are other things we can do to reduce the many gaps in the evidence on which treatment is best for individual patients.

One source of gaps is that the data that we receive in conjunction with the approval process for new products are from highly structured clinical trials. Quite frankly there is no way that such trials will ever provide a complete picture of how a new treatment will actually perform when it's used in a much broader variety of patients in the real world, where patients don't always take their medicines on time or take them at all, where they might have other medical problems, where they have unusual co-morbitities, unusual diets, or where they might be taking multiple other medications or dietary supplements.

As a result, in addition to too many medical errors, a lot of complications or adverse events occur in medical care. I think all of these should be viewed as potentially preventable. But to prevent them, we need to understand better why they occur and in which patients they are likely to happen. To make sure we learn as much as possible about safety and effectiveness of a new treatment in the real world, we need to learn more after it's approved. And we need to get this information quickly.

And we intend to make improvements here too. Right now, after a drug is approved, we depend mostly on so-called "spontaneous" adverse event reports to provide a basis for sorting out "signals" in the actual experience of using approved medical products that may indicate certain problems. I talked at the outset about how we are improving these safety systems. But such data have limitations.

First, although we are devoting more resources than ever to innovative statistical methods to pull out "signals" of potential safety problems from these data, it's hard. Only in cases where the signal is very strong, where extremely unusual events are occurring at clearly excessive rates, can these reports lead to a definitive conclusion. But in most circumstances, the signals that we detect are weak: they may reflect a significant effect, but it's hard to determine a causal relationship from these observational data. It's hard to know if events like complications from an illness are occurring more frequently than they would without the medicine.

Moreover, while we truly appreciate all of the health professionals who take time out of their busy practices to file these reports with us, we only receive reports on a small fraction - perhaps 10 percent - of the actual advents that occur.

In most cases, the reports raise questions that require further data collection, further investigation, and further analysis.

We will continue to need these adverse event reports - and so we will keep working to improve them. But we need more robust systems to complement our traditional spontaneous reporting systems. And so we are developing systems that allow us to collect more information about a drug's use in clinical practice, and to use this information more effectively. We need a 21st century system for monitoring drug safety and supporting more efficient use of approved products.

In these active reporting systems, we can receive more complete and reliable information in real time or near real time, by linking directly into electronic medical records and other information tools that are used in healthcare settings. Of course, for such systems to work reliably, we need more widespread adoption and implementation of electronic medical records.

The steps I've just described create important new incentives for encouraging the adoption of electronic medical records. For example, the barcode rule enables electronic barcode standards for prescription drugs that make barcode readers and the electronic records that go with them much more valuable. And gaining access to better evidence electronically on risks and benefits in particular kinds of patients is another important reason to adopt electronic ordering systems. In fact, my goal is to create a virtuous circle: We make some progress in collecting and analyzing information on risks and benefits of treatments in actual practice on a limited scale, as we are doing today. This leads to better information about the products we regulate, available through our DailyMed and other electronic information tools. In turn, this increases the payoff to adoption of electronic decision support and record systems, and that enables us to collect still better information, and so on and so on.

I have no doubt that this more modern, more effective system of product surveillance and patient protection will come to pass. But to make it come to pass as soon as possible, there are other important obstacles to overcome.

One important barrier to effective health information systems is the need to gain patients' confidence in the security and confidentiality of their medical records and in the ability to maintain secure linkages. The Department's final rule on medical data privacy, released last year, helps provide this assurance to the public -- while still allowing relevant information to be used for patient safety and quality improvement efforts. And we are building on this regulation by helping to develop systems for secure data interchange, for example to make sure that the adverse event information we need goes only to FDA.

We also need up-to-date electronic data standards that are sufficient to capture the complexity of medical products, practices, and health conditions and allow the transmission of this information over secure networks. In other parts of our economy, such as grocery stores and many other retailers, these electronic information systems are already common practice. One reason is that companies like Costco and the Gap have unique UPC codes, and all of their practices - sales, staffing, and so forth - can be adequately captured in electronic information systems. This is not true for health care: while we've been working hard at FDA to develop unique product codes for drug formulations, complete systems don't exist yet for many other medical products including thousands of medical devices.

We and other parts of HHS are already doing a lot of work to get those electronic standards, for example HL7 terminologies, SnoMed, and other health informatics efforts. We're also trying to make the system seamless, so that new products are automatically captured, by making the existing process of registering and listing them with FDA fully electronic.

And finally, there's one other incentive I want to mention that has in many ways been lacking. That's the need for financial incentives to encourage investments to develop and implement these systems. Where other high-risk industries have been commercially driven to learn from experience, healthcare often pays more in the case of errors. It often doesn't pay to improve quality. I know that paying for quality rather than paying for services is only starting to take hold. But there are other, smaller steps in the right direction worth considering, such as a small financial incentive for providing information to Medicare and Medicaid electronically - and private insurers can do this too. In addition, a small bonus might be provided for submitting electronic data to the government's public health surveillance systems. Companies might even be willing to pay for this, as an alternative to having to go to the trouble to generate and file an adverse event report with us.

Once more doctors are using electronic medical records, our hope is to make this kind of reporting a routine part of what they already do in their offices. And these data can be integrated with the increasingly sophisticated statistical tools we are using to assess patterns in the data. If we can continue to remove the obstacles and improve the benefits, the potential for improving quality of care and reducing costs is great.

I think we can do even more to improve drug safety and effectiveness. Think about the potential for doing better, more real-world clinical studies at a much more affordable cost. For example, post-approval studies could be much cheaper and easier to do, using clinical protocols administered over the internet via electronic records, with patients selected and results recorded directly from electronic medical records. Low-cost clinical trials to be performed more quickly and easily in real-world medical settings. And we can use the signals we obtain from our better surveillance system to work with health care providers, funding agencies, and health care payers to target these studies more effectively.

So we're doing all we can to develop active electronic surveillance systems, where we can use computer software to help us routinely scan electronic medical records for signals that could indicate problems with new drugs. This is a two-way street to make it worthwhile for health care professionals and organizations, by making better information available to patients and doctors who can use it to make more informed healthcare choices.

We'll keep working hard to find additional effective ways to protect patients from risks from medical products and to help doctors and patients understand the risks and benefits of the products we regulate. Developing and sharing better information about the risks and benefits of treatments is of critical importance in helping people get more for their money in health care.

Information technology has changed the every sector of our economy, whether it's sophisticated systems for relaying banking information across international markets, or the digital scanner at the local Wal-Mart that both speeds you through the check-out line and permits the store to adjust its inventories.

IT is a big reason why industries have been able to make significant improvements in quality over the last decade and implement quality systems and just-in-time delivery. And it's a big reason why the US economy has experienced huge productivity growth, including growth that topped seven percent last quarter. But IT has been slowly and sparingly adapted to healthcare. And so healthcare has not realized the same benefits from these new tools.

That's why I hope Congress will take this opportunity to realize a better future, and I hope they will join with us in working to include incentives and a framework for encouraging the adoption of e-prescribing and other IT tools in the current Medicare legislation.

For safer and more effective medicine, and that means higher-value medicines and better protections for consumers, we need to make these changes as soon as possible. We're also working on complementary changes to protect patients by making our drug distribution systems more secure - to prevent counterfeit drugs and otherwise unsafe drugs from reaching patients, by using modern electronic technologies such as automatic track and trace systems and authentication products. Altogether, these changes will create a much better 21st century system for safer, more secure, more affordable medicines in the United States.

We do need Congress to act to help. Most importantly, we need a 21st century Medicare system that includes prescription drug coverage, but we also need to make sure that we can implement all of the 21st century tools for maximizing the benefits of new medicines. This is the best way to provide safe and affordable prescription drug coverage to our seniors, as well as to make sure more Americans can realize the full benefits of modern medicine.