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Jane E. Henney, M.D. - Consumer Federation of America

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

Remarks by Jane E. Henney, M.D.

Commissioner of Food and Drugs



MARCH 19, 1999


Good morning. I am very pleased to be here today to speak to you as Commissioner of Food and Drugs. Organizations such as yours play such an important role in helping us to do our job as well as possible. Conferences such as this one provide a terrific opportunity for experts in the public health community to come together to discuss issues that are important to all of us as American consumers.

I have now been back at the Agency as Commissioner for a little over four months, and have found that my experience thus far has been extremely busy, exciting, and challenging. Because there is so much going on, I have found that it is extremely critical that we prioritize what needs to be done. While I know that we at FDA like to consider ourselves a "can do" Agency, I know that we cannot do everything, lest we spread ourselves too thin and end up not being effective at anything.

Therefore, this morning, I would like to highlight what I consider to be my highest priorities during my tenure at the Agency. They are: completing the full implementation of the Food and Drug Administration Modernization Act of 1997, strengthening the science and research base of the Agency, ensuring the safety of the food supply and blood supply, and continuing our efforts regarding tobacco. I would like to just touch briefly upon each of these priorities.

First and foremost, the implementation of FDAMA. With the enactment of this landmark legislation in November of 1997 came an extremely daunting amount of work for the Agency. I am pleased to note that thus far, FDA has met nearly all of its statutory deadlines, and has done what I consider to be an incredible amount of work since passage of the bill. I am extremely proud not only of the quantity and timeliness of the work that we have completed, but the quality of the finished tasks. So many of the provisions that were considered to be complex or controversial have been implemented in a manner that has generated very positive feedback from those outside the Agency.

Along these lines, we have also held a series of "stakeholder" meetings around the country in order to receive feedback on how the Agency has been doing in fulfilling its statutory mandate. Under section 406(b) of FDAMA, the Agency was required to develop an Agency Plan for statutory compliance, which was to be the culmination of discussions with our stakeholders. We published our plan in the Federal Register last fall, and we are continuing to have these stakeholder meetings around the country, including a videoconference that I will be participating in at the end of April. I look forward to receiving feedback from groups such as yours about how we can continue to do a better job as an Agency.

Second, I would like to turn to the reinvigoration of the science base of the Agency. I feel very strongly that the Agency needs to be confident that its decisions are based in the most recent scientific information available.

I want to ensure that the strongest, most up-to-date science underpins all of our decision-making. From the reviewer to the inspector, we can only be effective if we have a strong, scientifically-skilled workforce.

Since we must sit in review of new products that are the result of cutting-edge science, our judgments will only be as strong as our scientific expertise. It is imperative that we have the mechanisms and resources available to see that we maintain a presence in the world of science. We need means of retaining our best scientists as well as mechanisms for leveraging the intellectual power, and talent, of other science-based governmental agencies and academia. We cannot allow our staff to become stagnant. If we do not focus our time and energy on this area, the effects of our failure to do so could have a devastating effect on public health…our decisions will become risk averse—slow—or wrong.

Another of my high priorities for the Agency is ensuring the safety of our nation’s food supply. While our food supply in general is safe, our citizens are more at risk from food today than they have been in many years. This has happened because of a variety of factors. First, the food we eat in this country has changed drastically from a diet of meat, potatoes, and locally grown, seasonal produce. Today, we are eating a much greater variety of food, such as seafood and fresh fruits and vegetables. This food is often transported over long distances domestically and internationally; the combination of these new sources and wide distribution of food poses new safety challenges for the public.

We are also eating more food prepared by others. We have gone from the past, when most meals were prepared in the home, to today, when fifty cents of every food dollar is spent on food prepared outside the home. This includes ready-to-eat foods from restaurants and supermarkets. There are also a large number of Americans who have their meals prepared and served in hospitals, nursing homes, and day care and senior centers.

There has also been an increase in the number of people considered to be at a higher risk for foodborne illness. Today, nearly twenty-five percent of people in the United States fall into this category: the elderly, children, pregnant women, and the immuno-compromised. Moreover, the size of the vulnerable population is growing, particularly with our senior population being the fastest growing sector of our society due to the increased longevity that we now enjoy.

And, perhaps most importantly, more resistant old, and new and more deadly pathogens have emerged in our food supply. With respect to the latter, we are aware of five times the number of foodborne pathogens in 1999 than we were just fifty years ago, the most notorious of which is E. coli O157:H7.

As a result of these changes, outbreaks of foodborne illness are now all too prevalent. They seem to occur every day, everywhere, in almost any food. And, we are identifying more and more outbreaks associated with FDA-regulated products, such as apple juice, eggs, sprouts, raspberries, even toasted oat cereal, a product not generally regarded as high risk. While the numbers of deaths and illnesses associated with food have been the source of great debate, virtually all experts believe that many foodborne illnesses are preventable. Therefore, we have a public health responsibility to do what we can to minimize them. I look forward to working with our partners in the President’s Food Safety Initiative—within the Federal government, the Centers for Disease Control, the Department of Agriculture, and the Environmental Protection Agency.

Together we are enhancing the science that underpins all our food safety activities by pushing research and development in new food pathogen detection techniques. We are working diligently to enhance our surveillance capabilities, which helps us stop foodborne disease outbreaks before they become widespread, and helps us develop the knowledge to prevent future outbreaks. We are continuing to work with the food industries to develop guidelines, such as the good agricultural and good manufacturing practices that will do even more to prevent problems and to ensure an ever-safer food supply.

Another of my high priorities for the Agency is working to ensure that the nation's blood supply is as safe as it could possibly be. I hasten to note the remarkable progress that already has been achieved in improving blood safety in the last fifteen years. As documented recently in The New England Journal of Medicine, the risk of acquiring an infection from a blood transfusion is lower than ever before. However, it is absolutely critical that we maintain the confidence of the American consumer in the safety of the blood products that they and their families receive. To achieve this result, starting in 1997, FDA began to implement a "Blood Action Plan" to focus attention on improvements in the blood program intended to further enhance blood safety and increase the effectiveness of FDA regulation. Proposed rules in this area will be published for comment later this year and in subsequent years.

Last, but certainly not least, there is tobacco. We appreciate the strong support that we have received for the Administration’s activities to restrict access and promotion of tobacco products to minors. We are continuing our efforts to fight against tobacco, and, in particular, the toll that nicotine addiction takes on our nation’s children.

Over the past few years, we have worked on contracts with the States in order to conduct compliance checks of retail outlets that sell tobacco to ensure that they are not selling to minors. Along with these enforcement efforts, we have launched an anti-tobacco advertising campaign in radio, print and billboards. The early results from our enforcement and outreach efforts are encouraging. These important efforts will continue even as we await a response from the Supreme Court as to whether it will hear our case on the 1998 Circuit Court decision that held our regulations invalid.

Those are my high priority areas. However, the Agency has a great deal more on its plate, and I would like to discuss a few other areas that may be of particular significance to those of you in this room.

As you know, FDA’s mission is to protect the public health by doing its best to ensure that the products it regulates are safe and effective. However, product reviews must be efficient. FDA is not fully promoting the public health if it does not make timely decisions on applications to market products such as new prescription drugs and devices. But, it should be noted that any steps that we take toward getting therapies to patients faster should not be done by in any way compromising the very high standards that we have for the review of these products.

The product review record of the FDA in 1998 demonstrates the Agency’s exceptional performance. Drugs and other medical products are being reviewed as fast or faster than in any other country in the world. The 1998 approvals include a high number of products that represent significant advances over the products that were previously available. For instance, exciting new therapies brought to market in the past year include: several new treatments for breast and bladder cancer, a better tool for analyzing mammograms, new arthritis drugs, new AIDS therapies for both adults and children, and a diagnostic tool for osteoporosis.

Obviously, FDA has a high level of responsibility for assuring product safety during the premarket review and approval stage. This analysis for safety includes a thorough risk/benefit analysis of the products in the population where the product is intended to be used. However, once products reach the market, risk management at the individual product level is also the shared responsibility of health care providers and patients. As a product reaches a larger and less rigorously monitored population than the clinically studied group, it is vital that adverse events be monitored. It then becomes crucial that we have an effective mechanism by which the Agency can receive information and act on these reports.

We must continue to explore the different roles played in the process of providing safe therapies to patients. We believe that some adverse events can be prevented if we work together to reduce avoidable risks through a better exchange of information about the products we use.

We need to ensure that health care providers, patients and consumers have the information necessary to make informed decisions and therefore avoid many of these risks. It is critical that patients and consumers be able to understand the information that is being provided to them about the products they buy and give to their families. Last week, FDA announced a final rule requiring a standard format for the label on all over-the-counter drug products. This new label will make the existing information on the label easier for patients and consumers to read and understand as they make critical choices about the medicines for themselves and their families.

It is also critical that we have strong, vibrant programs in place at the Agency. In order to do that, we need to get adequate resources to fund those programs.

The White House sent its proposed year 2000 budget to Capitol Hill earlier this year. This budget, although it is a $216 million increase—nearly 18%--over last year, is only a down payment on FDA's budget needs. I returned to the Agency after a few years to find that the base budget in certain critical areas was lower than it was when I left. Over the past few years, there has been a significant erosion of the funding base at the Agency that, if not corrected, will weaken our ability to do the work and provide the protection and service that consumers and patients have come to expect.

This erosion of the financial base of the Agency has had a devastating effect on some of our fundamental programs. Our funding has remained relatively stagnant with the only new money earmarked for specific programs—and yet, with the growth of technology, FDA’s responsibilities are becoming increasingly great and increasingly complex. Certain programs, particularly those provided with user fees, have been fully funded and fully operational. Yet, other, less high-profile areas have been forced to take losses equivalent to others’ gains and absorb inflationary costs.

I would now like to mention a couple key elements of the new budget. First, the request that we sent to Capitol Hill contains special funding for our high priority areas. An increase in funding for our food safety activities, if appropriated, will be used to build on the science base and expand capabilities in prevention and containment of foodborne outbreaks. And, an increase in funding for the Agency’s tobacco program will ensure that the progress made in contracts with the States may continue. We will also use this money to inspect an increased number of retail outlets that sell tobacco, and will expand its outreach efforts through new billboard material, and print, radio and TV advertising.

There are two items not in our general appropriations request but in the Administration’s budget request. One item involves money to be used for a Presidential initiative to respond to the threat of bioterrorism. FDA’s role in this effort would be to review products that may be used to treat illnesses caused by biological and chemical agents, as well as assist in the development of diagnostic tools and treatments for disease outbreaks caused by those weapons.

This year’s GSA budget also includes initial funding for the consolidation of many FDA functions in one location at White Oak, Maryland. The Centers for Drugs, Biologics, and Devices and the Office of the Commissioner would be located on this campus. I consider this to be another down-payment on a bright future in an efficient new setting and another critical ingredient to attracting and retaining the best people to our work.

The budget also includes funding for a program to enhance the amount and quality of injury reports. As I mentioned earlier, no product—drug, biologic, vaccine, or device--comes without risk. This is an area where a staggering amount of investment and work is needed. We need to develop a system that provides reliable signals when adverse events occur--and we must strengthen mechanisms to provide feedback to the health care community.

Another key element in the President's budget request is an increase in funding for our inspectional coverage of the firms that we regulate. In recent years, resource limitations have prevented us from inspecting firms as often as the law requires or the public expects. This proposed budget increase will begin the long road back to the appropriate levels of inspections.

As you can see, the FDA portion of the President’s budget contains funding for many areas that are very important to consumers and the public health. I look forward to meeting with Members of Congress and working diligently in an attempt to secure the resources that the Agency needs in order to do the job that Americans expect.

One last area that I would like to touch upon today involves an issue that has received a lot of attention from Congress and the media—the Y2K issue. I know that John Koskinen, the President’s Y2K coordinator, will be discussing this issue at greater length later today. FDA’s role in this issue is to work with the industry and others ensure that there are adequate supplies of safe and effective drugs, medical devices, and other FDA-regulated products available on January 1, 2000.

From information that we have received, it appears thus far that manufacturers are working diligently to assure that their systems are not adversely affected. Also, it is our understanding that manufacturers of implantable devices and other products that have raised concerns about patient safety will be compliant by the new millennium. FDA has created a website for users of medical devices who may be concerned about the products that they are using. This site provides current information provided by manufacturers about the compliance status of their products.

In conclusion, I feel that this is a very exciting time for the Agency. I am truly impressed with the caliber of people and the important work that we are doing. But we will only be effective if we continue to enjoy a strong partnership with you as we all seek to enhance the health of American consumers. For our part, I am committed to assuring that the FDA is a science-based regulatory organization that will constantly strive to do the best job that it can in protecting and promoting the public health. Thank you very much.