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Jane E. Henney, M.D - FDA Science Forum

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

Remarks by:

Jane E. Henney, M.D

Commissioner of Food and Drugs

U.S. Food and Drug Administration

for

"SCIENCE AND THE FDA"

Washington, D.C.

FEBRUARY 14, 2000

Good morning. It is such a pleasure to be here for this 6th annual FDA Science Forum. I would like to commend the forum organizers for putting together an exciting program. I am gratified to see so many of our FDA scientists here today, as well as our colleagues in the scientific community. When I spoke at the Science Forum last year, I had been in my new job as Commissioner of Food and Drugs for exactly two weeks and two days. Although it seems the time has flown, and we have had no shortage of challenges, much has changed on the science front at FDA since that time.

As most of you-- I'm sure-- know by now, especially those of you from FDA, I have made strengthening the agency's science base one of my very highest priorities.

A strong science base is not a luxury that we can enjoy when times are good, and cut back on when times get tough. Our scientific needs are cumulative. We cannot add, then subtract, and expect to subsequently restore a science base and continue where we left off.

The rapidly changing technology in today's research and development world presents us with new challenges on a day-to-day basis. Our agency is the gatekeeper for the products of genetic engineering, nanotechnology, and new techniques in the production of food additives and food packaging, among many others. As a guardian of the public health we must maintain the strongest possible scientific capabilities to meet these challenges.

A strong science base allows us to protect a public that depends on us for making safe and effective products available, in an informed, efficient manner. It's fair to say that the industry also depends on our scientific wisdom to help ensure the safety and effectiveness of their products, make timely decisions, and hence to a significant degree, support the industry's health.

The risks of not having a strong scientific foundation supporting our day-to-day decisions are considerable... and far-reaching.

As you know, one of my first actions as Commissioner was to appoint a Senior Advisor for Science -- Dr. Bernard Schwetz, former Director of NCTR and Interim Chief Scientist. Dr. Schwetz has become an essential advisor to me in all areas of FDA science, and a respected liaison to our management and scientists in the Centers and Office of Regulatory Affairs, and to the scientific community outside of FDA.

The next position I am seeking for my staff is a Deputy Commissioner, and we are nearing the end of our search for this person. We set the bar quite high in terms of scientific recognition and experience in managing a science-based organization. My vision is that the person in this position will work in partnership with Dr. Schwetz, and together these two individuals will be a strong science force in the front office--and for the agency.

But to be strong as an agency we need to continue to attract and retain an enormous wealth of scientific talent at all levels of the agency.

There are many challenges in maintaining a scientific organization strong enough to have credibility world-wide.

A strong science-based organization depends on the training, retraining, and continued learning of all of those in the agency who rely on science to ground their decision-making--those involved in review work, research, and investigative work in the field. These components are interwoven to provide a scientific safety net capable of ensuring the safety of the multitude of products we regulate. Our scientists must be up-to-date in their areas of expertise, quick learners in new areas, and willing to adapt to the rapidly changing technologies facing them.

It is one of my goals to ensure that scientists have the time and opportunity to spend at least 10% of their time honing their skills and learning new ones. What does this mean to a staff that already has a workload that is stretching it to its limits? It means that we must have 110% of the workforce needed to do the work--so there will be a necessary buffer of time for those who need scientific skills and training to do their jobs--to get out of the office and lab to attend seminars and courses within the agency, participate in scientific meetings and workshops, go on sabbaticals to academia or industry, and develop collaborative efforts across the agency and with their colleagues in the outside scientific community--and still get the work done. This will not only require time but financial support for travel and training.

I am well aware that our scientists engaged in research need support in the lab in terms of equipment and technicians so that they can focus on the scientific questions before them and take full advantage of the capabilities of everyone on the team.

We know these things are necessary and we will afford them as we can.

Our office of human resources has enlisted a contractor to work with the scientific staff to address the question of "what should the configuration of our scientific workforce be--now...5 years from now...10 years from now." The contractor is in the process of conducting surveys and interviews to evaluate the current workforce that will help us characterize the workforce needed over the next 10 years. They are also looking at ways that we can improve our ability to recruit and retain scientists so that we can attract and keep the kinds of high quality people we have always depended on. FDA's workforce must be flexible...adaptable, to effectively deal with the questions we will face in the future.

Because...as Arnold Glasow said, "The trouble with the future is that it usually arrives before we're ready for it."

This brings me to another important piece of my effort to enhance the science base of the agency. As many of you know, the FDA Science Board is the federal advisory committee that advises the Commissioner, Senior Advisor for Science, and other agency management on the quality and direction of FDA science, and scientific issues as they come up. Since my tenure as Commissioner began, I have begun repopulating--and redirecting the focus of the Science Board. I will be asking the Board to take a more active role in addressing such issues as recruitment and retention of scientists, and peer review of our scientists and our research programs.

Establishment of a consistent process for peer review is an important initiative in the effort to ensure the quality of our science. The Science Board is charged with overseeing an ongoing series of external reviews so that we get feedback and guidance on the quality and mission-relatedness of our work.

Applying the latest scientific knowledge and thinking sometimes means that we have to go outside the agency for help. We frequently do this on an informal basis--calling people we know in other parts of the agency, or in academia or industry, to solicit opinions and advice on a particular issue.

We also have a long history of collaborating with the external scientific community on a more formal basis, through cooperative agreements, interagency agreements, memoranda of understanding, cooperative research and development agreements, and contracts... But we are now making this kind of leveraging central to our operations.

Leveraging - we've used this term frequently in the past year when we talk about strengthening our science base. And although some of you may be growing weary of hearing the word, the concept is critical to our ability to get our work done. I want to be clear about what leveraging means--and doesn't mean. It does not mean simply contracting out work--although there is a place for that too. When I talk about leveraging scientific resources I'm talking about investing our resources in collaboration with others to help us get the job done faster and with expertise we may not have in-house. By pooling our financial and intellectual assets we are able to achieve results greater than either organization could have achieved alone.

In order for this to be successful, we must have a core of expertise within the agency that is knowledgeable in the particular area in which we would like to collaborate, and internal activity in the area to serve as a springboard for getting more work done.

Leveraging should be a primary strategy for us so that we can bring a wider range of scientific thinking to bear on public health issues. It's a smart way for us to do our business.

We have quite a number of examples of this type of collaboration that have recently been employed by FDA with our colleagues inside and outside the agency. I'll mention just a few of these.

One is the joint training involving FDA and industry that was started by the Office of Science and developed by ORA, with participation by the centers. The first such course was co-sponsored with Merck-on barrier isolation technology. FDA investigators and Center scientists visited Merck's Pennsylvania manufacturing site for a course on the latest in barrier isolation technology. A second course was conducted last month in Minneapolis, co-sponsored by FDA, the Grocery Manufacturers of America, and the National Center for Food Safety & Technology on the "Applications of ELISA Rapid Screening Methods to FDA Field Investigations."

These courses have been enormously beneficial in updating our field investigators and center scientists, and have provided a scientific milieu for scientists from industry and the FDA to sit down together in a neutral environment and talk about the "science" of specific new technologies. Participants have had the opportunity to share their perspectives on the challenges involved in bringing a new technology onto the product development or manufacturing scene.

A number of these training courses are planned for the remainder of this year in the areas of devices, drugs, and biotechnology, and we plan to continue these in future years.

Other examples include:

  • JIFSAN--a partnership between FDA and the University of Maryland. JIFSAN is involved in areas of risk assessment and education for the Food Safety Initiative.
  • FDA's National Center for Toxicological Research in Arkansas has fostered a number of collaborative efforts using outside scientific expertise--including research to assess potential carcinogenicity and toxicity of many different chemicals and products regulated by FDA.
  • The Product Quality Research Institute, or PQRI, developed by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research, is a not-for-profit organization devoted to research in support of science-based regulatory policy on product quality information. We are working with outside scientists-and, in fact-with the American Association of Pharmaceutical Scientists (AAPS), our Science Forum co-sponsor--to develop this collaboration between FDA, industry and academia to identify and develop best practices for the manufacture of high quality pharmaceutical products. This group has formed a number of working groups comprised of technical experts in the areas of drug substance, drug product, biopharmaceutics, and science management.
  • The National Center for Food Safety and Technology, in Chicago, is an example of an effort between academia, industry, and government to develop alternative ways to reduce the risk of food products that have the potential for causing foodborne illnesses, for example, in sprouts or juice.

These are just a few of many examples.

We have a clear vision of our priorities. One of our current areas of emphasis is a stronger linkage with other agencies within the Department of Health and Human Services and outside the department to enhance progress toward our goals.

For example, it is to our benefit to develop stronger linkages with the NIH so that we will be prepared to deal with the new therapeutic products and technologies resulting from the enhanced support of basic and clinical research at the NIH.

As you will hopefully hear from Dr. Eisenberg, partnering with the Agency for Healthcare Research Quality and other health care organizations will help reduce the incidence of death and disability associated with drugs, devices, blood and a variety of other products used by consumers and patients. It is FDA's responsibility to maintain its high standards in pre-market decision-making, and to work with other involved agencies to look at how risks related to the products we regulate are managed throughout the entire health care delivery system.

In the area of food safety, our cooperative relationships within the FDA, within the Department, and with agencies of other federal, state, and local governments enhance our ability to make the food supply even safer and reduce the incidence of illnesses and death caused by foodborne pathogens.

We have new challenges in the area of biotechnology-derived foods. We continually evaluate our process for ensuring the safety of these foods, and are satisfied that the bioengineered foods that are currently on the market are safe. We are enhancing our communication with consumers and the science community about FDA's procedures for overseeing the safety of these products.

In another area--interagency cooperation is critical for assuring the availability of new vaccines to defend against bioterrorism. In addition to our review of submissions for vaccines related to bioterrorism, we are working with the Dept. of Defense, CDC, and the Assistant Secretary for Planning and Evaluation on ensuring an adequate reserve of these vaccines.

In the area of antimicrobial resistance--we are working closely with CDC and USDA in the areas of research and surveillance to effectively monitor the development of antibiotic resistance as a result of antibiotic use or misuse in humans and animals. We are strengthening our research, educational, and regulatory efforts to head off public health threats from antibiotic resistance, and to respond quickly if they do occur.

Our agenda is very full. How can we apply the "science of safety" in all these areas?

I think most of us here today understand that "safety" does not mean "no risk." It is simply not feasible to identify every possible adverse effect of a product before it is marketed. Analyzing safety often means the judicious weighing of the benefits as well as the risks of FDA-regulated products. To do this we must identify and assess the risk associated with a specific product, work to eliminate or minimize those risks, and communicate risk information to consumers and health professionals.

The title of this year's Science Forum -- the Science of Safety -- emphasizes the critical role of science in FDA's risk assessment and management decisions. The number of FDA-regulated products--from drugs to devices to food additives--is rising rapidly, and the complexity of these products is increasing dramatically. The potential for interactions between drugs, or between foods and drugs, is also growing. The spectrum of responsibility for risk management is very broad--from research and development of new products, to evaluating data derived from research, to physician prescribing practices, to consumer behavior.

Consumers participate in their own health care decisions to a greater extent than ever before, and they make decisions on a daily basis related to their health status-- from the foods they eat, to the over-the-counter products they choose, to how well they comply with taking prescribed medications.

It is FDA's responsibility to ensure that our safety assessment and risk management decisions are based on the very best scientific information available and we take this responsibility very seriously. We continue to evaluate our procedures for hazard identification, risk assessment, and for managing risk--from pre-market review to identify potential problems before products are approved, to post-market surveillance designed to identify new, unexpected adverse events once products are on the market.

I am excited to see that the program for today and tomorrow includes the latest perspectives on analyzing and managing risk in areas that are very important to FDA, the industry, and the public--including food safety, post-market surveillance, women's health, and the latest technologies for evaluating risk associated with the many products regulated by FDA.

Thank you for your invitation to speak this morning and for the privilege of working with you.