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Mark B. McClellan, M.D., Ph.D. - White Oak

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.

Phase 2 groundbreaking at White Oak
Remarks by
Mark B. McClellan, M.D., Ph.D.

Commissioner
U.S. Food and Drug Administration,
November 15, 2002

Good morning, and thank you for the introduction.

First of all, my colleague, Deputy FDA Commissioner Lester Crawford, and I wish to welcome our distinguished guests: Senator Paul Sarbanes, Senator Barbara Mikulski, and Congressman Steny Hoyer who have come to join us from the Capitol Hill; Mr. Douglas Duncan, the Montgomery County Executive; and Mr. Stephen Perry, the GSA Administrator.

I also want to recognize Messrs. Robert Thompson and Harold Adam from the design architecture firm Kling and RTKL, and Mr. John Tarpey from the Centex Construction company, all of whom have done a great deal to make this event possible.

On behalf of the FDA, thanks to all of you for coming.

And I want to add my personal thanks to the Shades of Blue Jazz Combo from the Springbrook High School in Silver Spring -- and to its musical director Wyman Jones -- for their fine performance.

Yesterday, the Vice President swore me in to the most important job I have ever had: Commissioner of Food and Drugs. And I am very pleased that my inaugural event as Commissioner is the inauguration of this fine building at FDA's new White Oak campus. A groundbreaking may seem like a beginning, but many of you here today know better. Those who have long supported FDA's efforts to consolidate its more than 40 facilities throughout the DC area, and to bring those facilities up to modern standards, you have my thanks, and the thanks of the ten thousand professionals who work for the FDA. I especially want to recognize everyone here who has contributed to the tremendous efforts of LABQUEST to make this day possible.

This is another milestone on the road to the modern, integrated facilities that the FDA needs to support its work. It is also an important step toward enabling the historic resources of the White Oak Naval Research Station to continue to contribute to the quality of life of Montgomery County, which is a great place to live and to work.

Standing here today, I don't see just a nice tent and a construction site. I see a better future of the FDA. Never in the storied history of this agency has the need for thinking about its future been greater.

As you all well know, our agency has one main purpose: to protect and promote the public health of the people of the United States. Meeting this great responsibility in the 21st century requires FDA to meet some unprecedented challenges.

First, the volume of activities for which the agency is charged with regulating has been increasing, and is likely to continue to do so. This is a good thing. There are more drugs and medical devices available to save and improve lives, and even more to come. We are importing a larger volume and greater diversity of foods than ever before. There are broader choices in cosmetics, and in dietary supplements. As a result, Americans have more opportunities to improve and enjoy their lives than ever before. But this also means, more than ever, that FDA must think critically and carefully about how it uses its resources to improve the public health. In some cases, this may require a reexamination and an updating of the way FDA does its job. We are not here just to check boxes on an inspection list, just because that's the way we've been doing it for the past 20 years. We are here to implement the best possible approaches to reduce risks to the public health, using the budget and authority that Congress has given us. This challenge requires expert knowledge, creative thinking, and dedicated effort, day in and day out.

Second, since last September, we have learned all too painfully that we are not safe from terrorism in its many forms. The FDA has a critical role to play in making our country more secure from terrorism, by helping to make available safe and effective treatments for anthrax, smallpox, and other possible forms of bioterrorism. And the FDA must act quickly to protect our food supply and other consumer products from new threats.

Third, we must continue to adapt to the changes in the drugs, devices, and other medical treatments that are becoming available. For example, just a few decades ago, Americans who had a heart attack and were lucky enough to make it to a hospital got supportive care to make them comfortable. Since then, the various centers - back then, bureaus - at FDA have approved many safe and effective medical treatments that have changed that picture. CDER has evaluated and approved breakthrough drugs such as ACE inhibitors; CBER has evaluated and approved new biological treatments, including so-called "clot-busting" drugs; and CDRH has approved stents which have saved lives and avoided costly surgeries. All of these new treatments have contributed to an enormous reduction in the death rate from heart attacks in this country in the past two decades.

In the years ahead, we can expect more breakthroughs resulting from a better understanding of the human genome and of the way proteins and other chemicals work in the body, and from progress in information technology, nanotechnology, and other fields. These new kinds of medical technologies may require some new thinking at FDA, in terms of how we should best design our review processes for drugs, devices, and biological treatments to help Americans get safe and effective treatments as quickly as possible, and at the lowest possible costs. I've already learned in my very short time on the job that thinking ahead is nothing new here: the FDA's professionals have learned that innovation and change is the norm in the American health care system, and that we must design our regulations and programs with the future in mind.

Another challenge ahead for FDA is to help medical professionals and patients reduce preventable adverse events. From our efforts to set standards such as bar-coding on medical products -- to help make sure that the right patient gets the right treatment at the right time -- to our efforts to make greater use of modern medical information systems to identify adverse events involving FDA-regulated products more quickly, accurately, and cheaply, FDA is working to make health care safer.

For all that better health care can do to help Americans live longer and better lives, however, it's important to keep in mind the great importance of our own lifestyle and choices. According to many experts, whether or not we smoke, what we eat, whether we exercise, and how we live can significantly impact on our health. And here too, FDA has a critical role to play: we are charged with making sure that the claims that products make about their effects on health are truthful and not misleading. As Americans have become more interested in taking steps to improve their health, and as we continue to learn more about actions we can take or avoid to improve our health, it is critical for FDA to help make sure that American consumers are getting good information to guide their decisions.

These challenges - dynamic and responsive regulation that is always searching for new and better ways to reduce risks to the public health; quick responses to the new challenges of bioterrorism and food security; promoting quick access to new medical technologies that are safe and effective; helping to reduce adverse events involving FDA-regulated products; and helping consumers get truthful and non-misleading information about the products they use - these are among the many critical challenges that the agency faces as it looks forward into the 21st century.

The President and Secretary Thompson have highlighted many of these issues. As health care costs rise, they are working to find ways to improve access to new medical treatments that can improve health. They are working to find ways to improve the safety of our medical care, and to prevent medical errors. They are working to help people stay healthy and prevent diseases in the first place.

I know the members of Congress here today share these goals. In recent years alone, the FDA and our public health have been strengthened and advanced by important new laws - including, in the most recent session of Congress, the Bioterrorism Response Act, the reauthorization and enhancement of the Prescription Drug User Fee Act, and the new Medical Device User Fee Act. These laws, which all had strong bipartisan support, will help the FDA address new risks to the public health, and new opportunities to improve it.

The FDA has an enormous task ahead. No nation has a greater resource than the health of its people, or a duty more imperative than augmenting this asset for the coming generations. And looking forward, the opportunities to improve our health and reduce the risks to our health are greater and more diverse than ever. And these challenges are increasingly global: growing trade and international travel increase the importance of promoting the equivalence of public health protections; leveraging resources for inspections; and harmonizing technical standards for medical devices and for veterinary drugs, to mention a few of the global challenges in which the United States must lead.

For decades, the FDA has worked to meet these critical responsibilities. The agency has matured and improved over time into one of the most indispensable government agencies in this country, and one of the most respected public health agencies in the world. In the last four decades, for example, the FDA has provided leadership for global improvements in food safety, engineering standards, and technical requirements for drugs and biologics.

But one aspect of FDA's work has remained, and will remain, unchanged: the critical importance of the FDA's professional workforce for the success of the agency and for its ability to maintain the high level of public trust in its activities.

A clear sense of our critical mission at FDA is important -- but a clear sense of mission is not enough to attract and keep the sort of highly qualified and highly motivated employees who are essential to meeting the challenges that the FDA faces in the 21st century. An organization that can keep up with the rapid changes in the industries that it regulates, and that is capable of developing and implementing effective and innovative public health measures, requires a very special workforce.

Our mission depends on a solid cadre of experienced scientists, physicians, mathematicians and other highly qualified and dedicated professionals. Their expertise is essential for making our regulatory decisions balanced and fair, and for keeping us on the cutting edge of the technology and sciences used by industry.

As FDA Commissioner, it is one of my foremost goals to make sure that the FDA's working environment encourages creativity, efficiency, and superior performance - an environment in which the FDA functions effectively as a single agency that consistently supports top-quality work by all of its employees.

One important element of recruiting and retaining the best FDA workforce is a first-class, modern workplace. And that's why I am so pleased to be able to participate in this groundbreaking, which is an important step to a better future.

The interior design of this building is not yet finished, but I am told that most of the approximately 1700-1800 CDER employees who will move here will have individual offices with more elbow room than they have now.

By the time this building is ready for occupancy, we also plan to have completed the construction of another facility, a central building housing shared services, which will include a cafeteria, fitness center, health clinic, credit union, and library, as well as rooms for conferences and training.

When this new 130-acre FDA campus is ready, its 25 buildings will house all of the FDA's product centers except for CFSAN. And while CVM was not part of the original program, we hope it will be also located here, as well as the Office of the Commissioner.

In the meantime, even as we continue to make progress towards an integrated physical campus for FDA, we need to take more steps to provide "virtual" connections to help people work together across the agency. We will improve our FDA-wide information technology systems, our telecommunications capabilities, and the support from the Commissioner's office for collaborative programs across our Centers.

In addition to investing in improvements in our work environment, we must also do more to invest in our employees. It is not easy to keep up with the rapid and complex changes in biomedical sciences, clinical practices, and manufacturing techniques in the industries that we regulate. But it is essential for our agency to do so.

Partnerships that help bring the latest knowledge into FDA are a resource that FDA needs to use more often. FDA's cooperative agreements with universities and colleges include arrangments for sabbaticals for our employees as well as for faculty members who want to spend some time working at the FDA, or join our research projects. We need to examine these programs, and augment those that are most effective.

We have several staff colleges that provide in-depth training on scientific, technical and regulatory topics; our staffers can participate in a variety of on-line courses; and we have a dynamic leadership development program. We need to work together and with other Federal agencies to expand these opportunities for continuing education and professional development.

And, where there are important benefits to our ability to regulate effectively, we must promote the involvement of FDA professional staff in research activities that are relevant to fulfilling FDA's dynamic and forward-looking mission. Particularly in areas of emerging technologies where the promise is great but the path to safe and effective products is not clear -- such as in many cell and gene therapies -- effective regulation requires a close connection to the latest scientific developments.

A work environment that allows FDA's professional staff to be productive and to keep pace with rapid change is essential to attracting the kind of employees that FDA needs. But finding and keeping dedicated and talented employees requires doing more. FDA is already taking many steps to find the employees we need - and with our growing responsibilities and many possible retirements, we need a lot of them. We have several active intern programs to help the agency achieve long-term work force diversity; we offer a Master Reviewer Program to promote senior scientists without requiring supervisory responsibilities; and we have a very active college recruitment program.

FDA is also highly regarded for many programs that it has implemented to recognize the diverse needs of our workforce. I support these programs. Our employees can take advantage of flexible work schedules, including an "any-80" program that can fit the difficult schedules of two working parents, sick kids and sick parents, and other outside commitments. About one-fifth of our employees take advantage of our flexi-placing program, which supports telecommuting. And we offer support for employees with child care, elder care, and other distinctive needs. To attract and keep high-caliber employees who can respond to the changing needs of the agency, we need to be equally responsive to their diverse needs.

Finally, we must reward employees who distinguish themselves and who remain committed to our agency despite attractive outside job offers. On the one hand, I'm glad that so many of our employees have other good options. That tells me that we are attracting very talented people. On the other hand, I don't want to lose them.

We therefore offer a range of programs to help retain talented staff, such as a 10 percent retention bonus for employees in two occupations with a particularly high turnover. We are also working to provide additional financial rewards. For example, our agency has recently completed agreement with the National Treasury Employees Union to reinstate a policy on awarding Quality Step Increases as an incentive for high performing workers. And we have plans for future initiatives: for example, we want to offer a new retention allowance for our physicians; develop a dynamic succession plan and clear career paths for employees who will replace those who retire; and develop a counseling program for newcomers who are embarking on a regulatory career.

As Commissioner, I am determined to work with my new colleagues at FDA to strengthen our workforce, to improve our agency, and to get our job done. Protecting and improving the public health is a noble and great purpose: it provides daily opportunities for excellence and creativity in making our country a still better place to live.

I want to thank my fellow FDA workers for their dedication to the mission entrusted to us by Congress and our fellow citizens. And I want to thank you all again for all your efforts to make it possible to bring the agency's nearly century-old tradition of promoting the public health into the 21st century and its new home at the FDA White Oak Campus. The future of the FDA is here and now. Thank you.