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Andrew C von Eschenbach, M.D, Commonwealth Club

Speech before
The Commonwealth Club

Remarks by
Andrew C. von Eschenbach, M.D.
Commissioner of the Food and Drug Administration

"The FDA's Blueprint for Change"

June 10, 2008
This text contains Dr. von Eschenbach's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Thank you, Bruce Ericson, for that very gracious introduction.

I must confess that when I compare myself to the other distinguished speakers who have addressed the Commonwealth Club, not only am I greatly honored, but truly humbled. However, it is also true that I have been looking forward to this opportunity because I believe the gravity of the topic I intend to address today equals that of many important messages presented to this prestigious audience.

At my Senate confirmation hearing almost two years ago, Senator Kennedy—whom we all hold in our hearts and prayers today—said that the FDA was, in his opinion, the most important federal agency engaged in healthcare. Not only do I agree with that statement, but I would add the comment—sweeping, yet true—that the health and welfare of every single American depends on the FDA, every single day.

Let me bring this down to the personal level.

This morning, you woke up, brushed your teeth, showered, washed your hair, and applied deodorant. Many women put on some make-up, some of us cleaned and put in our contact lenses and, because we are in sunny California, you hopefully put on sunscreen. Then you took your vitamins and perhaps other dietary supplements.

If you have gray hair like me, you might have taken medication to control cholesterol and a baby aspirin to prevent heart attacks. And if you happen to be the Commissioner of the Food and Drug Administration you would have also taken medication to control your high blood pressure.

Then you joined the rest of your family and had your orange juice, cereal, with fresh fruit, perhaps an omelet with cheese, tomatoes and fresh herbs and, after that breakfast, fed the dogs and cats, and packed lunches for the kids to take to school.

In the first hour of your day—before you even left your house—the FDA has already touched your life in dozens of ways. For the entire day, more than one fifth of the products you purchase are regulated by FDA. In fact, they are the most important products when it involves protecting and promoting your health.

The next time you enter a large supermarket note that, with the exception of the meat and poultry counter, nearly everything else you put in your shopping cart is regulated by the FDA. Every trip to the doctor or hospital involves placing your trust in a product regulated by the FDA…from the blood pressure cuffs to the X- ray machines, from the pills to the pacemakers.

Today was a good day for you and me. We are all here, and healthy. The system works so well that we have taken for granted the quality of our food, drugs, and medical devices. But on any other given day, things could be a lot different.

What if, this morning, your toothpaste was tainted with diethylene glycol, or antifreeze, your contact lens solution was contaminated, your dietary supplement contained a dangerous unapproved drug, your pet's food was poisoned with melamine, your omelet or the peanut butter in your child's school lunch was laced with lethal bacteria?

We don't have to imagine these things occurring because we have faced all of these threats within the recent past. Today, we are all well aware of how vulnerable we are when it comes to our protecting our health.

The FDA was created just over one hundred years ago with the mission to protect the American people from products which may cause them harm. During that time, the FDA has become the world's gold standard regulatory agency. In the past few decades, our mission—to protect Americans of all ages—has expanded dramatically because of the massive proliferation of products which now come under the FDA's regulatory umbrella.

But we have been asked to do even more. Congress has charged us with the responsibility to not only protect, but also to promote, the public health by assuring the effectivenessof medical products, as well as, their safety.

The people of the FDA have accepted this mission to protect and promote the health of every single American, not just in those first few hours of our day… but throughout the day, each and every day.

In doing so, the FDA holds itself to highest possible standard—perfection. While we know that perfect is not possible for mere mortals, it is the goal we must strive for. The men and women of the FDA know that safeguarding the health and well-being of the American public is a zero-defects operation. There is no margin for error—because when errors occur, people may die.

I am here today because many have questioned whether the FDA is capable of such a task. I am here today because the question befitting the Commonwealth Club is not whether, but how, can we assure that the FDA—the most important Agency in health care—is capable of such a task. I am here today because "failure for FDA" is not an option. It's not an option for you and the medication you took this morning, it's not an option for our children and the food that must nourish them, and, it's not an option for your loved one who desperately awaits that effective treatment for cancer, Alzheimer's or AIDS.

The importance of assuring the success of FDA is apparent but the more probing question is, "what is the source of potential failure and what can be done to eliminate that possibility?"

Many now recognize that—for a government agency with such a grave responsibility and vast regulatory portfolio—failure can result from not having sufficient resources or enough authority to accomplish the tasks required. That fear becomes even more real when people learn that the FDA's annual budget is about half of the budget for the University of California's medical centers.

Without a doubt, the FDA needs increased financial resources, as well as, expanded regulatory authorities. On this point, even the agency's staunchest critics agree. These self-evident facts are important but I am here today to speak about far more than the need to support the FDA—I want to speak about the need to transform the FDA because simply doing more tomorrow of what we did yesterday is a formula for failure.

Today, in every aspect of life, we recognize that the world is rapidly, and radically, changing and so the FDA must also rapidly and radically change to adapt to this new world of challenge and opportunities. I am here today to tell you about two of the most profound changes in the world that are affecting the FDA: the impact of globalization, the progress in science and technology and some of the changes we are making in order to adapt.

Today, we live in a world where borders may be boundaries, but they are not barriers. Borders don't provide barriers to disease or to products which may harm us and borders should not act as barriers to the products and processes that can protect us. Global production and a rapid international supply chain make us all interconnected and interdependent, for better and for worse.

But not only do those products move more rapidly, and in greater volume…today, the very nature of those products has changed. Americans want choice and convenience especially in the food we consume. You know that we are facing challenges today with some types of fresh tomatoes. Part of the challenge the Agency is facing is that the source of our fresh tomatoes—which we expect to see in the grocery store 365 days a year—can be from all over the country and all over the world. So our investigation goes from the bedside of the sick patient to fields of tomatoes all around the world.

Even finished drugs and medical devices are no longer made in any one place. Medical products are not made in the USA but, rather, assembled in the USA with components and ingredients coming from every corner of the earth.

And products are far more complex because of new technology, like nanotechnology, complex drugs like biologics and monoclonal antibodies, and genetically modified food and animals. All these changes create new regulatory challenges for the FDA.

In today's world, we can't simply be "guardians at the gate," attempting to weed out dangerous products passing from production to delivery to you. Instead, we have to find a way to station ourselves at the very beginning of the production process—where ever in the world that happens to be—and maintain oversight, accountability and responsibility throughout the entire life-cycle of the product, right up until the time that food ends up on your dinner table, or that drug in your medicine cabinet or that medical device at your hospital bedside.

If it sounds as if I'm saying the FDA has to find a new way to do business, I am. We need new resources and new authorities to do new things. We need to implement initiatives that will enable the agency to be global in its scale and add to its scope the scientific breakthroughs and the latest technological innovations.

Our vision is to modernize this one hundred year old regulatory agency so that it is capable of meeting the challenge of ensuring the quality of food and medical products, whatever the source.

Some other things we need to do:

  • Expand our presence overseas and enlarge our corps of inspectors to make sure that all foreign manufacturing facilities comply with our standards,

  • Forge new agreements with foreign countries and trading partners to ensure cooperation in maintaining the standard of safety in products we require, and,

  • Break down technological and bureaucratic barriers to gain critical information from healthcare systems, insurers, and other government agencies to obtain real-time information on medical product safety.

The good news is all of these initiatives are well under way. But it will require patience and persistence to fully implement the changes that are needed.

And in addition to changing what we do, we are changing how we do it.

We are changing our culture:

  • To be not only science-based, but science-led, using modern science and technology to guide today's decisions and prepare for tomorrow's challenges.

  • To not only regulate, but facilitate, by proactively providing consultation and direction to discoverers and developers of innovative products so that they get it right for safety and effectiveness and can bring new products more rapidly into the market to save lives and improve health.

  • To enhance collaborations with our federal partners: the U.S. Department of Agriculture, Department of Homeland Security, National Institutes of Health, Centers for Disease Control, as well as, with state agencies and the private sector through efforts like the recently created Reagan-Udall Foundation.

  • To be flexible and open to change…including changing our regulatory process to make it more transparent, predictable, efficient and rapid.

  • To be engaged in the total life cycle of the products we regulate with a strategy of prevention, intervention and response so that we can build safety in at the outset of production and assure safety and quality long after products are approved.

Let me give you a recent example which illustrates the FDA's new culture in action.

In early January of this year, we learned about a group of patients who suffered a severe drop in blood pressure while undergoing dialysis or open heart surgery. As a result of this complication some patients died. One common factor among these patients is that they all received a large dose of the blood-thinner, heparin. FDA launched a wide-ranging investigation and the suspect product was recalled. Within a week, we were able to isolate the active ingredient used in the specific lot of the drug and determine its source—a facility in China.

We dispatched an inspection team to China but this time we were able to do so rapidly because today, unlike a year ago, we have a collaborative Memorandum of Agreement in place with the Chinese government. With our regulatory counterparts in China we also began to analyze the suspicious lots of heparin, using standard assays that have been in use for decades. We could find nothing abnormal.

So we went beyond FDA and we reached out to scientists in academia who were experts in heparin chemistry and asked for their help in determining the culprit. Using very sophisticated state of the art technology—such as nuclear magnetic resonance spectroscopy and capillary electrophoresis—we discovered that the contaminant was a substance that so closely mimicked heparin activity in appearance, that our conventional testing could not detect it.

Once we identified the contaminant, the FDA developed a rapid screening test and immediately shared that test with other regulatory agencies around the world. Other countries were able to check their own their own drug supply and we determined we had uncovered a global problem. Today, the problem is under control and the American heparin supply is safe.

But tragically, 81 people died in the United States from severe allergic reactions to this contaminated product before we were able to respond and intervene. Tomorrow, we want to not only do better to detect and respond, but to prevent these problems from ever occurring.

The challenges we are facing, and will continue to face, are always changing. Like a flu virus that mutates into a new strain and thus can't be destroyed by last year's vaccine stockpile, or a type of bacteria that grows resistant to the supply of antibiotics we currently have -- we are facing threats that will continue to morph, evolve and transform, in order to try and evade our tests and defenses. This kind of threat can only be defeated with an approach that is resilient, adaptable and determined to outsmart it. And that will continue to be our response in the future because so many lives depend on these medical products being safe. And equally important is the fact that we need them to be even more effective.

So many lives are at risk because today because we do not have drugs or devices that are solutions for some cancers, for AIDS, for Alzheimer's and so many other diseases.

Some people are concerned that the pipeline for bringing these solutions to patents is drying up. They say that the process of gaining approval from FDA is too long, that the time and expense required to develop a drug and get FDA approval to bring it to market are simply too great.

Today, I'm going to tell you that our medical product approval processes can be made much better. The science and technology of discovering and developing life saving products can also be used to make the regulatory process what it should be.

One improvement is to modernize the clinical trials process. This process has served us well in the past but it is slow, laborious, and fraught with failure and, most importantly, exposes thousands of patients to drugs and medical devices before they are proven to be safe and effective.

The science and technology of discovering and developing life-saving products can also be used to make the regulatory process what it should be. One improvement is to modernize the clinical trials process.

FDA is working to revise this entire process. Through our Critical Path Initiative, we are looking to biomarkers, which can provide early signals of toxicity before a drug can do significant damage to a patient, as well as, to predict which patients might benefit.

But no matter how much we improve clinical trials, these clinical trials can't possibly be large enough, diverse enough or long enough, in duration, to provide all the information on a product's performance and safety. We simply cannot predict every possible problem which may occur when millions of patients start using the product. Some problems will emerge when patients have other diseases, creating a risk that wasn't apparent in the clinical trials. Other patients may be taking additional medications, which pose a problem when used in combination with the new product. Some patients may have an underlying genetic condition that poses a risk that extends to a very small sub-set of the patient population.

For these and several other reasons, it is critically important that FDA develop the capability to gather as much information--on a continual basis---about the impact of the new product on all patients long after the product is approved and on the market .

Currently, through the adverse event reporting system, the FDA now uses we gather primarily negative information about the product's impact on patients. When a patient experiences a serious side effect or negative outcome while using a product, their doctor reports this incident directly to FDA or to the manufacturer (who is required to report it us).

It is clear to see how, and why, this system is suboptimal. We have to wait until a sufficient number of people recognize and then report ill effects that they conclude may be from the product before we can do an analysis and take corrective action.

To make this system better, FDA just launched the Sentinel Initiative, with the ultimate goal of implementing a national electronic safety system capable of tracking the performance of a drug or medical product. This system, beginning with the earliest stages of clinical research and continual monitoring of the product as it reaches millions of patients throughout the health care market will, eventually, expand our capabilities.

Instead of having to wait for reports of adverse events to reach us, Sentinel will eventually allow the FDA to search multiple data bases of large health care systems to assess how patients are reacting to a medical product, whether problems appear in combination with other medications, and whether dosing levels should be adjusted for particular patients.

But what about the regulatory process itself? How can FDA improve its own internal processes to become much more efficient, transparent and predictable? This past year, we launched our continuous process improvement program. Initially, we are focusing on how to improve internal business processes to balance our own efficiency and effectiveness. But we are also addressing steps in our regulatory process, such as improving how we manage Import Alerts that stop admission of suspicious products at our ports or improve how we conduct advisory committees to inform us about drugs and devices, and other FDA-regulated products.

Our goal is to be a 21st century regulatory agency that facilitates the discovery, development and delivery of life-saving and health-enhancing products to patients and the public.

Some may say that the only appropriate role for the FDA is to regulate, not advocate. They say that when it comes to drugs and medical devices we should be concerned only with oversight, and not with innovation…when we work with food producers we should think only of safety and not of nutrition and healthy eating.

This kind of thinking assumes that the only valid approach to industry is an adversarial one. I believe that mindset is dangerously outdated. And it completely misses the point. Because the point is achieving safety, the point is achieving better results for more patients, the point is saving lives by preventing negative side-effects before they can happen, and customizing the therapeutic approach to meet the needs, and accommodate the risk factors, inherent in every single patient.

My goal is to help speed the transformation of the FDA into an agency that proactively protects and promotes the health of Americans; for FDA to be flexible and adapt to the rapid and radically changing world around us; to use modern science and technology to assure optimal performance.

Our goal is to create an FDA that is a bridge, not a barrier, to the next generation of cures, more effective therapies and the promise of personalized medicine. Obviously, we can't do it alone. And I'm not reluctant to ask for the help we need to make it happen.

I'm asking you today, for your support and understanding as the transformation takes place. The more you understand about what we are doing the better off we'll all be. So I urge you to go our website, gain a better understanding of the efforts underway, walk the path with us, and let us know what you think.

I have asked Congress to grant the FDA nearly a dozen new authorities, including the ability to force manufacturing facilities that fail to meet our standard to bear the cost of re-inspection, to require food facilities to renew their certifications every two years, and at the top of my list…I want Congress to grant the FDA the authority to ban the import of products to the US from any company which delayed, limited or denied access of our inspectors to their facility…and give us the ability to destroy, not return, defective medical products which have been refused admission to the U.S. so that those potentially dangerous products can't do harm to patients anywhere in the world.

In this interconnected, interdependent world we live in today, America needs to demonstrate global leadership in promoting food quality and drug safety and effectiveness…and in raising these standards beyond our borders. This is the only way to ensure protection for each and every American.

Yesterday, the President submitted to Congress an amendment to his FY 2009 budget to include an additional $275 million for FDA to accelerate the innovations I have discussed here today, as well as, to implement the many other specific proposals we have presented in our strategic plan last November.

We are extremely grateful to President Bush and to Secretary Leavitt for proposing this initiative, but it will become a reality only if, and when, Congress acts on it.

Those who retain the right to be critical—at some point also have the responsibility to be constructive. By the end of the week Congress will have held 49 FDA-related hearings over the past 18 months at which we have discussed the many needs and concerns that FDA must confront, and one point of consensus was that the agency must have additional funding.

These dollars will translate into additional scientists, inspectors and regulatory experts. These dollars will help create a modern system of information technologies capable of rapid data sharing. These dollars will pay for the FDA to have a greater ability to make the wise decisions that you and your family depend upon each and every day.

For those of us fortunate enough to be in this room today was a good day.

If we all work together to transform the FDA—for millions of Americans—tomorrow can be even better.

Thank you for the honor of being your guest at the Commonwealth Club. Thank you for the opportunity to tell you how, and why, we must accomplish this transformation.