Arlington, Virginia

Tuesday, December 19, 2000

Mr. Lawrence: Welcome to The Business of Government Hour. I'm Paul Lawrence, a partner at PricewaterhouseCoopers and the co-chair of The PricewaterhouseCoopers Endowment for The Business of Government. We created the Endowment in 1998 to encourage discussion and research into new approaches to improving government effectiveness. Find out more about the Endowment and its programs by visiting us on the web at endowment.pwcglobal.com.

The Business in Government Hour focuses on outstanding government executives who are changing the way government does business. Our special guest tonight is Dr. Jane Henney, commissioner of food and drugs, at the Food and Drug Administration.

Welcome, Jane.

Dr. Henney: Well, it's very nice to be here, Paul.

Mr. Lawrence: Well, let's start out by finding out more about the Food and Drug Administration. Most of our listeners will be familiar with FDA as the agency that regulates food and drugs and ensuring they are safe. But they don't -- perhaps don't realize that the FDA also regulates medical devices, cosmetics and protects the public from unnecessary exposure to radiation. Can you tell us more about the agency?

Dr. Henney: Well, the FDA does have a tremendous breadth of jurisdiction over products that come into the marketplace. It's not just drugs, but prescription drugs, over-the-counter-drugs. It's devices, anywhere from tongue depressors to MRI equipment. It certainly is foods, about 90 percent of what you see on your plate every day is in some way regulated by the FDA, and we try to assure the safety of the food that you eat.

There are other things: The drugs that you may give your pets, or if you were raising cattle or pigs, the medications that you would give your farm animals are regulated by the FDA. And the whole issue is that we exist, really, for consumer protection and promotion of the public health.

Mr. Lawrence: The mission is so diverse, how many people are at the FDA and what type skill sets to do they have?

Dr. Henney: Well, we have about 9,000, a little over 9,000 that work at the FDA. We are spread all across the country; our main headquarters is here in Washington, D.C., but we have district offices all across the U.S. because one of the things that we are expected to do at our district offices is do inspections, do surveillance work of that regulated industry that we have oversight of.

Also, to communicate to the public in those areas of the country about FDA, to be available for them when they want to report something that they think is a problem with a medical product they're using, or if they think that there's a question about the safety of the food that they are eating. So, we aren't just an organization that is here in Washington.

In terms of the kinds of skill set that we need within the agency, most of the people that come into the agency must have a scientific background. Even our inspectors that work in the field have to have vast number of hours of science because what underpins most of the safety of products that we regulate is whether there's scientific evidence to show that those products are safe.

The medical officers, the scientific officers that work in the center on drugs or the center on biologics that look at vaccines or blood safety, they have to be tremendously skilled scientifically.

We, of course, have our own because we are enforcing a statute: The Food, Drug, and Cosmetic Act. We also have a number of lawyers that work in our general counsel's office. And then if, to keep any organization running, you have to have good clerical and administrative support staff. So we have that kind of mix; it's very heavily weighted, however, to having people that are strong in their own scientific disciplines.

Mr. Lawrence: Tell us about your career and the various positions you've held.

Dr. Henney: My career has been largely in public organizations. I am a medical oncologist, by training, a cancer specialist. But I first came to government service in 1976 and stayed through '85, when I was at the National Cancer Institute. I came in at a very entry-level position as a drug monitor for investigational drug studies and my last five years there, however, was spent as the deputy director of that institute.

I then went to a publicly funded organization at the University of Kansas. And I was there for several years doing a mix of administration and also seeing patients.

I was then recruited back into government service in the early '90s, when I was the deputy commissioner for operations at the FDA. I left the agency in '94, going to the University of New Mexico, again, another publicly funded organization that my particular position was vice president for Health Sciences.

And we had a school of medicine, college of nursing, pharmacy, all of the allied health disciplines, and a wealth of clinical facilities, hospital and ambulatory care sites. And so, that was my little sector of the university. And then I was recruited back to the FDA. So, three times in government service, two times in academia, but always at publicly funded organizations.

Mr. Lawrence: Do you think your tenure as deputy commissioners helped you as commissioner?

Dr. Henney: I think that particular part of my career has helped me enormously. I think for anyone who comes into the commissioner's office who has not had experience either with or in the agency, it takes them a long time to get oriented, to get grounded into not only what the agency does, but the processes it uses to do its work and to become acquainted with the people that are doing that work. And for me, I consider myself very fortunate to have been, essentially, the COO of FDA, because in that position, I recruited many of the people who still are in leadership positions at the agency.

About 90 percent of the agency was really under my direction at that point, so I became very familiar with the process the agency uses to review drugs, to review devices, the issues that are there with respect to blood safety and what goes on in the field. I actually went out into the field several times with the inspectors, and so that in my own background made coming back both easy and smooth for me to move into the position of commissioner and feel like I had enough experience under my belt from day one to be effective as a commissioner.

Mr. Lawrence: Your career is about public service. And I'm wondering, what drew you to public service?

Dr. Henney: Well, when we were first recruited or when I was first recruited to public service in 1985, it was really to complete some of my training as a medical oncologist when I was at the NCI. And I think what I saw from that early experience was something that attracted me very much and has, you know, really been the force that's had me staying in public organizations. And that is that you really feel like you're serving the greater public. You are held accountable in ways for that service, and what you do every day really makes a difference to people. And I think that service -- whether it's in federal service, or whether it's in a state-funded institution, or whether it's serving on the county commission -- can be tremendously rewarding in feeling like you're doing something, not only for your own career, but something that really advances the health and well being of the public around you.

Mr. Lawrence: Which of the positions you've held gave you the best opportunities to develop as a leader?

Dr. Henney: I think, looking back on that, probably the experience that I had at the National Cancer Institute. I was fortunate in being able to grow and develop there fairly rapidly and assume a fairly senior position at that institute. I also had a boss there who let me work by just a couple of rules. And his one rule for me was: do anything you want to, but at least five minutes before you get yourself into real trouble, would you tell me? And letting me have that kind of flexibility to take on challenges, but knowing that I had somebody that would either back me up or would at least try to save me from too big disasters was just a tremendous growth experience for me.

Mr. Lawrence: Well, great and it's time for a break. We'll be right back with more of The Business of Government Hour.

(Intermission)

Mr. Lawrence: Welcome back to The Business of Government Hour. I'm Paul Lawrence, a partner at PricewaterhouseCoopers and tonight's conversation's with Dr. Jane Henney, commissioner of food and drugs at the Food and Drug Administration. In the second segment, let's talk about the review process. Each year, the FDA certifies about 1,000 new medical products for marketing. After a careful review of research data submitted in the manufacturer's application, how do you manage the review process?

Dr. Henney: Well, the review process differs a bit, depending upon the product that you're talking about. In the area of drugs, the number is actually about -- in the range of 60 to 70 every year. And we actually do a couple of things. One, we first give a determination as to, is this a product that's going to be used for a serious and life-threatening disease, or is it the first product in its category? And if those things are the case, we put the drug on a fast-track for review.

All other drugs and then given a very reasonable review, but we do have a priority setting that occurs when we are looking at a review process. We also make sure that every product that we are reviewing meets a very high standard. So we're not totally working by the clock here. We're working by a priority system against a high standard. And then we expect to meet a performance standard that's actually outlined in our Prescription Drug User Fee Act. We are now down to about six months for the review of a drug that's going to meet the needs for a serious and life-threatening disease and about twelve months, on average, for those other drugs. All of them, though, to be approved, must meet the same high standard.

In the device area, where hundreds of things are reviewed, we clearly review them and our level of scrutiny each of those products is really by risk. Those products that may pose a higher risk for a patient -- like implantable devices, something you're going to walk around inside of you for a long time -- you want to make sure that it is very well tested, that the clinical data is very solid, that it meets a very high standard for safety. And so that might be different than that tongue blade, or a variation on a tongue blade, that may need some scrutiny. But, certainly, not at the level of review.

So, we review, we categorize in the device area by risk and then we do our reviews based on the amount of clinical data that we might need. Again, every device that gets reviewed, however, must have our stamp for safety and effectiveness.

We've also, in the device area, looked at others outside the agency that we could have oversight of, but they could actually be trained and learn to do the review. So we are using what's known as a third-party review, where we've identified different groups that are capable of looking, using our standards of review, doing it on our behalf. We continue to monitor what they do to make sure that the agency's work is done in the correct way.

In the biologics area, it's done in much the same manner that I described for drugs. There again, there's a priority setting. Drugs that are for serious and life-threatening diseases, biologics in that area -- be they gene therapy or otherwise, any biological product -- are given the fast-track review again. They must meet the high standard.

In the foods area, those aren't really medical products, but we do have reviews that go on in the foods area for food additives. And again, there's a priority setting done by the agency. And in that way, we can concentrate our efforts and our time with those products that may pose the most risk or are the most needed and, therefore, gauge our urgency of review and our intensity of scrutiny of the review.

Mr. Lawrence: How do you balance the competing needs of the speed and the accuracy in making and doing the reviews?

Dr. Henney: Well, the accuracy is first and foremost, because all products that enter the marketplace must meet our gold standard of review for safety and efficacy. And that has not changed. We have found, however, that with the additional resources that we were provided under the Prescription Drug User Fee Act some years ago, we were able to hire more reviewers and more scientists, and in that way -- by having greater resources available to us in terms of people power -- we can get our work done in a more timely way. So, we have also gained speed, but we have never dropped our standard for what the review must be in order to get an approval.

Mr. Lawrence: Well, speaking of people, what type of training is available to the scientists who review these products. I mean, how do you keep them up to date?

Dr. Henney: Well, there are a couple of different things that I think it might be interesting for your audience to know: We hire reviewers from some of the best and most prestigious universities and training programs in this country, from Harvard, from University of Washington, from Michigan. I mean, we have people that are being recruited into the agency that are very smart. They're very bright, they are very strong in their clinical areas or in their scientific disciplines, but what they will do at the agency, as they look at the review of a new product is different than anything that they have been trained in.

So, at the agency, we run staff colleges, in terms of what it takes to do an actual review. So we have formal training programs that go on. In fact, our training program that's in our Center on Drugs Evaluation and Research was just the recipient of the Demming Award. We won the first place in government for our training program. I was very proud of the group. And so, we do a very formalized process training individuals in the review process and keeping them up-to-date in terms of new regs that may be coming along that will impact on the review process.

In terms of their professional or their own disciplinary training, we try to provide what we can in that regard, because it's important that our reviewers and our other people who impact on decision making in the agency are really at the top of their game in terms of their professional discipline. If there is an area where I think we need to do more, it's in that area. We need to provide opportunities for people to attend their professional meetings, to give papers, to be seen as true colleagues with folks in academia or in other federal scientific agencies, so that we can hold our own because, after all, what we are doing is sitting in judgment of some of the finest scientific work that is done in this country and to be a judge, you not only have to know the field, you have to understand it and make correct assessments as to whether this science, this new product is now ready for the marketplace.

It is a job that requires a lot of knowledge, it requires a lot of wisdom and so, we need to be investing in that ongoing professional development of our folks.

Mr. Lawrence: How do you address turnover amongst the reviewers?

Dr. Henney: Well, actually, recruitment for us has not been too much of a problem. Retention is an issue, because people come in, they are given and provided and expected to do something that takes a unique body of knowledge and with that knowledge, then, they become prime targets for recruitment, particularly by the regulated industry and, certainly, by academia. And so, the retention issue is a real challenge for us.

In many ways we can't compete oftentimes with the salary structure that is out there for our reviewers that become well-versed in what they do. We certainly do have the appeal of a unique kind of job, a different kind of impact on the public health. And we try to also provide career ladders so that people can move and advance within the agency.

Mr. Lawrence: Well, it's time for a break. We'll be right back with more of The Business of Government Hour. (Intermission)

Mr. Lawrence: Welcome back to The Business of Government Hour. I'm Paul Lawrence, a partner at PricewaterhouseCoopers and tonight's conversation's with Dr. Jane Henney, commissioner of food and drugs at the Food and Drug Administration. In this third segment, let's talk about managing the FDA. The FDA reports that it performs its regulator tasks at a cost of $4 per American taxpayer per year. How does the FDA maintain its high level of work, while minimizing these costs?

Dr. Henney: Well, I do think what you point out is that FDA, in terms of the service it provides to the public, is a real bargain. And we do this, essentially by trying to direct our resources to areas of highest risk to the consumer. It means that we can't do everything necessarily that we would like to do. We have to have a very strict priority setting about what we will do within the agency. We also have to have enough planning that we can handle the emergencies that clearly come up from time to time during the year. But we go through an exercise, and it is quite formal in some of the centers and more informal, but known and respected, in the other centers of what will be the priorities for the year, where will the resources be dedicated. But it does mean that we can't do everything.

Mr. Lawrence: By some counts, 25 percent of the economy is under the purview of the FDA, which leads to a high degree of public scrutiny. What lessons have you learned about managing an organization in the public eye?

Dr. Henney: Well, my whole career, really, has been at publicly supported institutions, whether in the federal sector or when I was at state-supported universities. And I think what I have learned about being in the public eye is that the accountability and the level of scrutiny is very high. But in ways, I think, if one can learn to manage in that kind of arena, and manage in that kind of arena with integrity and credibility, it not only advances your day-to-day work, it advances the whole notion of why your organization exists.

The public, I think, by and large, wants its agencies, whether a federal, state, or publicly-supported organizations to work, and they expect to have a fair amount of scrutiny over whether the dollars they are investing are working or not. So, I think that comes with the territory. I think it's a level of accountability that we all expect and should have.

Mr. Lawrence: The FDA has multiple stakeholders: Consumers, advocacy groups, scientists, companies, trade associations. How do you interact with these stakeholders and what are the lessons learned for other government groups trying to build partnerships?

Dr. Henney: Well, I think that many of those groups are stakeholders, if you define a stakeholder as a group that is interested in or impacted by your business. And the business of the FDA and its regulation does impact many groups, from health professionals to consumer groups to patient advocacy groups to our regulated industries. And they are stakeholders. I think the general public, however, if government could be described as a business and I'm not sure that it can because it is, just intuitively, not in business, but I would use the word stockholder.

The public is paying taxes and expects something from its federal agencies. From us their expectation is protection and promotion of their health, and I think when we hear from them it's with a different kind of ear, if you will, than perhaps all of our stakeholder groups, who have a different -- have interest in us for, perhaps, a different reason.

But in terms of our interaction with either our stakeholders or our stockholders, we, as an organization, have tried to be both open and transparent in our work from the very beginnings of this agency, and we're trying to increase that level of openness to an even greater degree, I think, as we move into this next century. We have very formalized meetings with our stakeholders at different times during the year. We clearly have all of our rulemaking is notice-and-comment rule making, so we can hear from either the general public or from any group on any rulemaking that we have under consideration. Our dockets are open. We've opened up our website to consumers, to the general public. And it is a very popular website, we get about 800,000 visits every month from individuals visiting for as little a few minutes to 17 minutes at a time, so we know that they're really looking for information about us.

We hold meetings with consumers. We just held one a couple weeks ago, where consumer groups could tell us, in terms of our planning at the agency, what they saw on their own agenda and how we might address some of the things with them.

Mr. Lawrence: Could you tell us about the FDA Modernization Act of 1997? What's been its impact and what challenges has it presented?

Dr. Henney: The FDA Modernization Act of 1997 was really opening up our act and looking at several things. One was our basic mission statement and underscoring the fact that we both protect and promote the public health as an organization.

It then got into a great level of detail, in terms of anywhere from management tools that we might legitimately explore and use within the agency and things like third-party review and devices, to things like the renewal of the Prescription Drug User Fee Act in biologics and drugs. It really was a sweeping piece of legislation. It caused the agency to have to develop a number of regulations and guidances, the interpretation, or the making operational, if you will, of a statute. And I believe we have met every deadline that was expected in that Act. And so, I believe that we are staying true to both the letter and the spirit of that law.

Mr. Lawrence: And how about the Food Safety Initiative and its impact?

Dr. Henney: Well, the President's food safety initiative has, I think, been a tremendous boon to the American public. Over the last three years, while the food safety initiative has been going on, both throughout the federal government and, also, our working with state officials and through our educational initiatives, we have seen a 30 percent decrease in food-born illnesses that have been caused by the five most common organisms that create food-born illnesses for us. We still have a lot of work to do. People still get sick every day from food-born illnesses, so we are looking at things within the agency, like -- things that sound mundane but are very important -- like the proper handling and storage of eggs. Telling consumers what they should look out for as they eat eggs, you know. Not going for the sunnysides-up anymore, but making sure that they are cooked, not using that raw egg in your Caesar salad anymore. We have other regs that look at things like pasteurizing juice, fresh juice that may be a carrier for E. coli 0157 that in some can be a deadly disease. So anywhere in the food safety initiative, anywhere from very strong consumer education initiatives about cleaning cooking, not cross-contaminating, these kinds of things, to regulations that are going out to our regulated industry that deal with the processing, the safer processing of foods.

Mr. Lawrence: It's time for a break. We'll be right back with more of The Business of Government Hour.

(Intermission)



Mr. Lawrence: Welcome back to The Business of Government Hour. I'm Paul Lawrence, a partner at PricewaterhouseCoopers and tonight's conversation's with Dr. Jane Henney, commissioner of food and drugs at the Food and Drug Administration. We hear a lot about the forthcoming retirement wave and the difficulty of attracting young people to government. Can you tell us whether these issues are problems for the FDA?

Dr. Henney: Well, Paul, just like all agencies of government, I think we are looking very intently at our succession planning. We do see, at the FDA, that wave of potential retirees, people that could, if they decided to leave in an instant because they already have their years in and then a group that is within two or three years of that, as well. Fortunately, for those that are retirement eligible, they also are a group of extraordinarily dedicated people to the agency mission. And what has struck me as I have been signing off on certificates, there's a number of people that we also have that are willing to give not just the typical amount of time to government, but 30, 35, 40 years and so. We have been fortunate at the agency to have people who are very committed, very dedicated to the FDA, so while we have to be aware that they could leave at any time, we also know that folks tend to stay around because they become very committed to what the agency does on behalf of people.

We are, however, taking under consideration our own succession planning; looking at the kind of scientists that we will need, particularly to address the needs of technology that is coming along in the future; looking at new and better ways that we can use to recruit and retain people in government services. But, also, being aware that the wave of people coming into any enterprise, whether it's government or the private sector or the university setting is a much more mobile one. People nowadays, as you well know, tend not to think of a lifetime career with an organization. And we, as an organization, have to be prepared that people may come to us for four, seven, ten years, but not stay with us forever. So, we also need to be looking at and are looking at things like training, retraining and also looking at people that go out for a few years and may want to come back. And so, we have that under very intense scrutiny.

I've also said that I think one mark of leadership, and of management, if you will, but particularly of leadership is not just to get through every day with an "A" on your chart at the end of the day. But, as a leader, you're supposed to be expected to look at how the organization will look in five years and ten years, and build the kind of capacity that will allow the organization to grow and develop for its future challenges, and to allow it to grow and develop as an organization that can attract people to its work.

We emphasize very heavily, in the FDA, taking people in high school, in colleges, during their medical training for a short or longer experience, be it a month, three months, a year spent with us. We think that may attract them back to the FDA, but even if it doesn't, it may give them a taste of what it's like to spend time in government service. And I've had a couple of students with me, one particularly this past summer, and I must say, it is also very energizing for the person to have a student to be constantly questioning why you do what you're doing, curious about what your work is all about, and if you can take trainees into your work site, I think you're doing also for your organization in terms of looking out after its future needs.

Mr. Lawrence: You described one aspect of leadership was to think about the future, five to ten years from now. How do you see the FDA changing in the decade ahead?

Dr. Henney: I think that the FDA will change. It will stay the same in some very critical ways, in terms of, I think our standard for safety and efficacy and judging medical products will always be a high one. And our commitment to consumer to protection won't change, but I think many of our processes may well change. In terms of openness and transparency, we've done a reasonable job. I think that there are more opportunities for us to do more in terms of engaging both the general public as well as our regulated industry in terms of what the agency is doing. We're starting to do more in terms of posting information on our website. Not just about information that may be helpful to the consumer, like, how do you use the Internet if you are going to be purchasing prescription drugs over the Internet, what are wise things to look out for but also, we're posting things like our inspection visits to industry, warning letters, so that the general public also knows what is going on between us and the industry so far as compliance is concerned. So it really is a whole range of things that I think can increase our openness our transparency to a greater public.

I think as a regulatory agency, we come up against another issue, and that is, as the nation has adopted a very aggressive trade policy, to really be all that we should be in terms of making those agreements work, regulatory agencies must be strong and must be party and privy to those kind of discussions very early on, so that the standards for safety or for health that are embedded in some of those agreements, to make sure those standards are high, so that we don't lose a standard that we've set for our own country because another standard has been set somewhere else. So we need to be engaged in the early discussions of these trade agreements.

We also need to be engaged in terms of how the agreements will be enforced when it comes to matters that intersect with the agency's business. And then, thirdly, we need to be there when disputes arise, to make sure that the dispute is settled in a way that is based on scientific evidence, not just on the particular feeling of a country about an issue.

So, a regulatory agency, it's very important that a regulatory agency such as the FDA be strong and well invested in, so that it can make sure that as globalization occurs, as free trade occurs, both for the nation as an exporter, as well as an importer, public health and safety is well-protected.

Mr. Lawrence: What type skills will leaders of this future FDA need?

Dr. Henney: I think leaders of the FDA will always need to be very well versed in the scientific -- their own scientific discipline and committed to scientific evidence as the basis for decision making, because, after all, that is what our credibility with the public and our trust with the public relies on. There was a Pew study done this spring that asked both the general public, consumer groups, patient groups, health professional groups, and the regulated industry, what regulatory agencies of government do you trust, and FDA fared very well in that survey, 70 to 80-some percent of all of those groups said they trusted the FDA to make the right decision. And so, we don't want to lose that kind of credibility. So a leader has got to stay steadfast in using scientific evidence as the basis for decision-making, whether it's on a new product review, whether it's on a policy, or whether it's on a compliance action.

Mr. Lawrence: Well, I'm afraid we're out of time, but I want to thank you, Jane, for being with us tonight. I've enjoyed our conversation very much.

This has been The Business of Government Hour. I'm Paul Lawrence, a partner at PricewaterhouseCoopers and the co-chair of The PricewaterhouseCoopers Endowment for The Business of Government. To learn more about the Endowment's programs, visit us on the web at endowment.pwcglobal.com.

See you next week.