The Business of Government Hour

 

About the show

The Business of Government Hour features a conversation about management with a government executive who is changing the way government does business. The executives discuss their careers and the management challenges facing their organizations. Past government executives include Administrators, Chief Financial Officers, Chief Information Officers, Chief Operating Officers, Commissioners, Controllers, Directors, and Undersecretaries.

The interviews

Join the IBM Center for a weekly conversation about management with a government executive who is changing the way government does business.

Dr. Mark McClellan interview

Friday, December 26th, 2003 - 20:00
Phrase: 
Dr. Mark McClellan
Radio show date: 
Sat, 12/27/2003
Intro text: 
Missions and Programs; Collaboration: Networks and Partnerships; Strategic Thinking; Leadership; Innovation ...

Missions and Programs; Collaboration: Networks and Partnerships; Strategic Thinking; Leadership; Innovation

Complete transcript: 

Friday, July 11, 2003

Arlington, Virginia

Mr. Lawrence: Welcome to The Business of Government Hour. I'm Paul Lawrence, partner in charge of The IBM Center for The Business of Government. We created the Center in 1998 to encourage discussion and research into new approaches to improving government effectiveness. Find out more about the Center by visiting us at www.businessofgovernment.org.

The Business of Government Hour features a conversation about management with a government executive who is changing the way government does business. Our conversation this morning is with Dr. Mark McClellan, commissioner of Food and Drugs. Good morning, Mark.

Dr. McClellan: Good morning, Paul. It's good to be here with you.

Mr. Lawrence: Great. And joining us in our conversation is Therese Morin.

Good morning, Therese.

Ms. Morin: Good morning, Paul.

Mr. Lawrence: Well, Mark, could we begin by finding out more about the FDA? Could you tell us about its mission and activities?

Dr. McClellan: The FDA has a mission that touches each and every American every day of their lives. People should be able to have confidence that the drugs that they're using are safe and effective; that the foods that they're using are safe, and that they're secure from the kinds of threats that this country is facing today from new sources, like terrorism. We have a major role to play in all of these areas.

We also deal with issues related to animal drugs. I've found out all the time about various areas that we regulate. A lot of people don't know that we regulate turtles; we regulate riverboats that travel between states. There are all kinds of areas where the FDA has activities.

Mr. Lawrence: How do you describe the FDA? And I'm particularly curious about the employees, especially the skills of the employees when you have such a broad range of activities.

Dr. McClellan: For all that we do, our employees are absolutely critical. Unlike many of the agencies in HHS that have a mission that involves funding programs, or providing medical services or funding medical services, the FDA is really about its people. Most of our budget, close to two-thirds, goes to human resources. And so our staff is absolutely critical in fulfilling our mission effectively. They range from research scientists to physicians who are still practicing medicines to expert chemists, people out in the field investigating potential violations of regulations and criminal activities. We work here in the country; we work around the world in trade negotiations and other areas as well. It's a very diverse workforce and one that's very dedicated and talented.

Mr. Lawrence: How about the history of the FDA? Why was it formed?

Dr. McClellan: We're actually coming up on the FDA's Centennial. It was formed in 1906. And in 1906, some of the biggest challenges that we faced were around issues of protecting consumers, protecting consumers from unsafe medications, protecting consumers from snake oil salesmen of one kind or another. And that is still an absolutely critical part of the FDA's mission. We're the nation's leading consumer protection agency.

In addition, as science has progressed, the medicines that we regulate are playing an increasingly important role in advancing the health of the public as well. So much of what we do in addition to focusing on protecting consumers is also focused on how we can get safe and effective medical treatments to people as quickly as possible.

On the food side as well, there is much more known today than was known a century ago about steps people can take in their diet and stuff, that companies can take in preparing foods and communicating about them can have a positive impact on people's health as well. So we're looking at our second century and we're looking at a mission that includes consumer protection and advancing the health of the public.

Ms. Morin: Mark, what can you tell us about your role and responsibilities as commissioner of the FDA?

Dr. McClellan: My role is to make sure we're doing our job as effectively as possible. We have a huge range of responsibilities: 80 percent of the nation's food supply, all of the medical products used in the country, everything that emits radiation. And we have a limited set of resources and a limited number of people to fulfill this mission effectively. So I see my job, first and foremost, as working with the expert staff in the agency to identify what the biggest public health threats are and the biggest opportunities to improve the public health, and then making sure we coordinate and use our resources effectively.

I also have an important role as the spokesperson for the agency, part of the public face that helps let people know about what we're doing and why. And with all of the things that consumers can do to protect and promote their own health, that public outreach is very important as well. So a lot of work on coordination and making sure we're spending our resources effectively as possible, and a lot of work on communicating with the public about how important steps they can take are to protect their health.

Ms. Morin: I know a lot of people are curious as to how one becomes commissioner of Food and Drugs. Can you give us an idea of your background and how it led to your new position?

Dr. McClellan: Therese, that's a very good question. I got to tell you, this is not something that I planned on in going through grade school or even five years ago when I was out practicing medicine and doing research in California. I grew up in Texas and spent a lot of time going through college working on issues related to biological sciences; did a lot of work in biolabs while I was going through college, and also spent some time back then on math and some other aspects of science. I double majored in English and in biology back in college.

I went on to medical school, planning to go into medical research of one kind or another. I actually started out intending to do neuroscience research, but the bench research turned out not to be for me. I've got a family that seems to have a lot of people involved in politics and law, and I think I just couldn't get too far away from that in the end. And one thing led to another and I ended up doing graduate work in economics along with my medical degree, so a combined degree, M.D./ Ph.D. program.

I went from there to completing my residency in internal medicine and then took a faculty job at Stanford University doing medical research, mainly focusing on economics of health care and the factors that influence innovation in health care; and also doing medical practice and internal medicine.

Ms. Morin: Do you think those positions helped prepare you for your position that you have right now?

Dr. McClellan: Well, they certainly are a part of the perspective that I bring to this job. The nice thing that I found about my work at Stanford was that, on the one hand, being involved in research and dealing with some of the cutting-edge researchers at Stanford and other institutions around the country gave me a chance to think long-range about where biomedical research was headed, how our health care system might function better, what the biggest challenges were that we're facing for the long-term. The nice thing about practicing medicine, though, is that it puts things right in front of you. Here and now there are things that you can do to help make people better: by talking to them about their problems and helping them understand them, by providing medical treatments that can help. And that kind of immediacy is something that you don't get in research.

The nice thing about working at FDA is that you get to do both. You get to think about the big picture, what should we be doing to help Americans live better and healthier lives? But you also get to take actions today that have an impact right away on the health of the public as well as heading us in the right direction.

I'm missing my medical practice. I haven't been practicing since I came in the government in this Administration. But I have really enjoyed the opportunity to both think about the big picture and to make a difference in people's lives. And I think that's what a lot of people find attractive about working at the FDA. It's a great place for combining the latest in science with actually doing things that have an impact on people's health.

Mr. Lawrence: You're the first economist to head the FDA, if I've done my research correct. How has that affected the way the job rolls out?

Dr. McClellan: Well, again, it's a perspective that I do bring to the job. We have done a strategic planning process at the FDA. That's something I'd like to talk about in a little bit more detail, given the interest of this program. And one of the issues that came up repeatedly in those discussions is that, gosh, there's an awful lot of things that we'd like to be able to do, but we just don't have unlimited resources, so we need to focus our efforts as effectively as we can. And one perspective that economists tend to bring to problems is the recognition that resources are limited and that activities have costs as well as benefits. And given limited resources, given benefits and cost, if we think hard about how we can maximize the benefits of what we're doing for the least cost possible, we can stretch our limited resources as best as possible.

So a lot of the work that we're doing has focused on finding efficient ways to get our job done. And I think that is a bit of an economic perspective. I don't think it's one that's completely new at the agency, though. Everyone who is familiar with the FDA knows that our dedicated staff will get pulled in a lot of directions and are used to trying to think about how they can get the most done with the limited resources that they have. So I think bringing the economic perspective more formally to this has, hopefully, made it a little bit easier to meet that challenge at the agency.

Mr. Lawrence: What are the challenges of working with a group that is highly educated and has many or a lot of advanced degrees?

Dr. McClellan: It's not so much a challenge as a great opportunity. I can go into a briefing on any topic, ranging from a food security issue to some new science on food safety to emerging technologies cell and gene therapy and hear from some people who really are up to speed with what's going on at or near the cutting edge of all of these areas of technology. And that kind of expertise is extremely important for us to do our job effectively. So I view it as an opportunity and, in fact, as absolutely essential that we keep our workforce up to speed with all of the increasingly rapid and complex developments in the various sciences related to the products that we regulate.

It does bring a different way of management to this organization than perhaps in some others. This is not a top-down organization in the sense that I can know going in exactly what the right answer is. I need to talk to the staff. I need to understand what the science has to say, what the policy issues are, and they're often very complex in the issues that we deal with, and that requires a kind of participatory process in management. But I tell you, it really helps us get our job done more effectively if we can work together and develop a common understanding and some shared specific objectives for carrying out our mission. And that's the way I try to manage the agency.

Mr. Lawrence: Does that affect the speed by which decisions are made?

Dr. McClellan: We have tried to do a lot to make sure that we can have a participatory process, and one that includes all of the relevant expert perspectives and still get things done in a timely way. That's actually one of our more important areas. One of the more important priorities that I have as the commissioner of the FDA is to make sure we can get these perspectives together quickly and work hard to do it quickly. The people in the agency are, more often than I would have expected, coming in willing to spend extra time in the evenings, extra time on the weekends, to make sure we get it right when we're having to make a tough decision under a lot of time pressure.

Mr. Lawrence: That's an interesting point about the decisions.

How long does it take to get a drug approved and what's involved? We'll ask Dr. Mark McClellan of the FDA to take us through this when The Business of Government Hour returns.

(Intermission)

Mr. Lawrence: Welcome back to The Business of Government Hour. I'm Paul Lawrence, and this morning's guest is Dr. Mark McClellan, commissioner of Food and Drugs.

And joining us in our conversation is Therese Morin.

Well, Mark, the FDA has mandated to play a role in homeland security, and you mentioned that at the top of the show. Could you tell us more about this, especially as it relates to Food and Drugs?

Dr. McClellan: Well, it's nothing new that the FDA has a major role in protecting the foods that Americans eat. For a long time, our mission had focused on food safety, how can we use the best sciences to reduce the risk of what can go wrong in food preparation and manufacturing and the like that could create illnesses, that could introduce toxic agents that could otherwise adversely affect the health of Americans. Now in light of recent developments in terrorism, we have to think about what might be deliberately done to our food supply to cause injury to Americans. And I'm sure some of your listeners have heard about reports of terror cells in Europe that were working on developing ricin and other threats related to agents like anthrax and the like that can be used in foods.

So we have responded to this new challenge, which is a top priority of Secretary Thompson's as well, by substantially expanding our work in the food security area. In fact, regulations that we're implementing this year, along with increased staffing, both of which resulted from legislation passed by Congress on bioterrorism last year, will amount to the biggest expansion in our food safety and security resources in at least 20 or 30 years. We are trying to implement this effectively. This is requiring a lot of new thinking, and we are at the forefront of the Administration's thinking about food security strategy, how can we get the most protection for the public against the new threats of terrorism. We're trying to do it in a way that's as least disruptive as possible on trade with other countries -- we're importing more foods than ever before -- and on production in this country not to impose any unnecessary costs or restrictions on the kinds of foods that people can get.

There are a lot of difficult questions here, but I think the good news is that if we do this right, we can not only protect the food supply against threats to our security, but also improve the level of food safety at the same time. We're doing this through such steps as developing ways of tracking back outbreaks of food-borne illness more quickly. We're doing it by increasing our inspections, especially at the border, but also involving food manufacturers in this country. And we're doing it through other steps to enable us to respond very quickly in the event of a food-borne outbreak, especially one that might be deliberately introduced.

Ms. Morin: One of the largest challenges facing the FDA is its drug approval process. How is the FDA dealing with this challenge?

Dr. McClellan: This is an important challenge, and it really I think couldn't be happening -- it's an important issue, especially today because of what's going on in the area of biomedical research. Today, we've recently sequenced the human genome in its entirety. There are new sciences being formed in genomics and proteomics that potentially give us the ability to understand why disease is occurring in a particular individual, and have a very targeted individualized set of therapies that can work effectively for that patient to prevent or hold back the disease. These are new kinds of ways of providing medical technologies, though, that haven't come along in the past. And it's our challenge, especially at FDA, to help make sure that we can translate these new insights into biomedical sciences, into safe and effective products for patients.

Right now, the level of spending in biomedical research and development is at the highest level ever, by far. The NIH has just completed a doubling of its budget to over $27 billion. A lot of people don't realize that there's even more private R&D spending going on now. The R&D spending by the pharmaceutical companies has doubled over the last 8 years, it's now over $50 billion worldwide; over $20 billion in R&D investment by biotech companies; and more R&D investment by device manufacturers than ever before. Yet in the past year, in 2002, we saw the lowest number of truly new drugs coming into our agency in more than a decade, and there's a disconnect there.

There is a tremendous amount of work going on in product development, but it's not yet showing up in safe and effective treatments for patients. And so a lot of our work is focusing not only on how can we reduce our review times while still assuring the safety and effectiveness of the products that we approve, but also on how can we use the knowledge that we have about what it takes to get a safe and effective product approved to make this development pathway go more quickly and smoothly. It costs over $800 million to develop a new drug today, and the success rates are extremely low. Even drugs that make it into advanced clinical trials, the so-called Phase III trials that are very costly, result in applications to us less than half the time. That's a very long and a very costly and a very uncertain process, and we need to do something about that. If we can find ways to bring down the cost and bring down the uncertainty of product development not only will it help patients, it will also help address the real challenges that we're facing in health care financing today.

Ms. Morin: So I guess, if I can summarize, the major challenge seems to be between speed, quality, and cost, and the goal is to maximize speed, maximize quality, and decrease cost. Is that safe to say?

Dr. McClellan: You know, a lot of people view the approval process as one that has to have tradeoffs where you can either do it more quickly, and that means that you know less about the products coming on the market and they might be potentially unsafe, or you can do it longer, have more extensive testing, and be more confident in safety and effectiveness, but because of the delays, that means many patients might not receive potentially lifesaving treatments. I don't think it has to be an either/or, and there's several reasons for that.

One is that last year, Congress passed new legislation, a reauthorization of our so-called Prescription Drug User Fee Program that gives us more resources to apply to each review that we do. That enables us to bring more manpower, more expertise in a more timely way to the product review process. In addition, we've been working hard to find ways to reduce the time to determine that a drug is safe and effective without changing our standards at all, and I want to emphasize that. The FDA has the world's gold standard for product approvals, and Americans can and should have confidence that the products that we approve are safe and effective. But there are ways to find faster mechanisms for doing that.

For example, we found a lot of cases where it took more than one so-called review cycle for a product to get approved. An application came into us, we found some problems, we sent it back to the product developer, they had to do some further work, come in again, and only at that point or later was the product actually approved. We're doing a root cause analysis of why those problems happened to see if we can avoid them in some cases. And one of the things that we found in at least some cases, if we can communicate early and clearly with product developers about what's needed to get a product approved, it can avoid those repeat cycles, and that reduces product development time and it reduces cost of product development without changing our standards at all.

We're also implementing new guidances through a collaborative process with outside experts to be clear about what the road map is and what the goal posts are for developing a new treatment in emerging areas of technology, like combination drugs and devices, and cell and gene therapy, and pharmacogenomics. And we're especially focusing on areas like obesity treatments, diabetes treatments, and cancer treatments, where our reviewers and our experts think there are a lot of potentially valuable treatments in the pipeline that are being formed or being developed using new technologies, and we want to be very clear about what it takes to get those new technologies approved.

So that's a way of reducing costs and reducing uncertainty in product development while still maintaining our very high standards. It's not either/or.

Ms. Morin: The responsibilities of the FDA do not end with the approval of the drug. The FDA continues to monitor the adverse impact of drugs once they're approved. How is the FDA planning to speed up the detection of adverse impact of drugs?

Dr. McClellan: Therese, we're doing a lot of things in that area as well. For all that we do to determine that a drug's safe and effective before it's approved, when the treatment gets out into the real world and patients that may have combinations of conditions or on combinations of medications, or the drug's being used and conditions of use that are just very hard to detect in any feasible clinical trial, new problems can be discovered, and we want to be able to find those quickly. We've started a new program at FDA with resources from that legislation passed last year, about $20 million per year or more, that enables us to enhance our post-market monitoring activities.

Earlier this year, we proposed a new regulation to enhance the reporting that comes into us from companies about adverse events. We did this in an international collaboration. The goal is to have one high-quality report on any significant adverse event or potential adverse event that involves a drug or biologic that we regulate worldwide rather than lots of different reports going to different regulatory agencies in a less timely fashion.

But I think the way for the future is not to depend just on our mandatory reporting systems with manufacturers. Good as those are, they're only as good as the reporting of increasingly harried health professionals, getting those adverse event reports into use. And according to the statistics I've seen, even the best systems were only getting about 10 to 15 percent of all the adverse events that actually occur. With modern medical technology and health information systems, I think it's possible to get, in real-time or close to it, automatic reports when an adverse event happens involving a product that we regulate. We've started implementing programs to do this on a pilot basis.

For example, we're collaborating with New York Presbyterian Hospital to work out the kinks in sending in information electronically about particular drugs and side effects that we're worried about, where we think there might be a problem. We've started a pilot program that involves now several hundred hospitals and health care organizations and our devices center that gives up information electronically over the Internet about potential problems involving the devices that we regulate.

And we intend for this to be a two-way street. We'll get the information in more quickly and reliably, and we can sift through it using data mining and other techniques to find potential problems, act on them more quickly, and send that information back out electronically. It's a much better way I think for the future to automatically and reliably and accurately detect problems with the products that we regulate and respond to those problems effectively.

Mr. Lawrence: Interesting. What does E-government mean in the context of the FDA? We'll ask Dr. Mark McClellan of the FDA to give us his perspective when The Business of Government Hour returns.

(Intermission)

Mr. Lawrence: Welcome back to The Business of Government Hour. I'm Paul Lawrence, and this morning's conversation is with Dr. Mark McClellan, commissioner of Food and Drugs.

And joining us in our conversation is Therese Morin.

Ms. Morin: Hi, Mark. The FDA also has plans to change the standards for making health claims for food. Can you tell us about that?

Dr. McClellan: Well, I can tell you that one of our top priorities in the agency is to get better, more accurate information to consumers about the health consequences of their food choices. We know more today than ever about the fact that people's dietary choices matter for their health. And recently, we've made some important announcements in this area. We announced a change in the Nutrition Facts section. This is something that's on the product labels of just about all the foods that you buy and tells you what the ingredients are. This was created about a decade ago, and this is the first significant change in Nutrition Facts. We're adding a line about the content of trans-fats in the foods that people eat. People should try to keep down the levels of cholesterol, saturated fats, and trans-fat in their diet. And giving consumers better information about the content of their foods is the best way to do that.

We also made a recent set of announcements about our process for encouraging companies to compete based on the health consequences of their foods. One of the first things that I did after coming to the agency was set up an internal task force that included our nutrition experts as well as experts from the Federal Trade Commission and the National Institutes of Health, to make recommendations to me about how we can encourage companies and better inform people to understand and compete on the basis of the health consequences of foods. And as a result of the report of this task force, we're going to make some significant changes at FDA.

We are setting up a process whereby we will review applications that come into us for putting a note on the product label about what the health consequence of a food is. And we're going to do this with expert advice not only internally, but also from the Agency for Health Care Research and Quality and other independent experts. And we're going to also conduct and continue to expand our work on consumer research on marketing studies for how people understand scientific information that's communicated to them about the health consequences of their foods. This will include a rating system where we make judgments about how strong the science is in support of a health claim. And it's all intended to give people an accurate place to get reliable information about what the latest science has to say about the health consequences of their dietary choices.

Let me give you a couple of specific examples. One that I think people will be seeing on their foods very soon is that eating a diet high in fruits and vegetables, at least five servings a day of fruits and vegetables, may lower your risk of some types of cancer and other chronic diseases. Others that we're reviewing in the coming months under this new process include the possibility that eating a diet high in omega-3 fatty acids, like is found in some kinds of fish, may reduce your risk of heart disease. And substituting foods that are high in unsaturated fats for foods that are high in trans- or saturated fats may reduce your risk of heart disease as well.

I think that food companies should be competing not just on taste and price and how easy a food is to prepare -- those are all things that consumers value -- I also think that consumers value the health consequences of food as part of an overall diet. And we want to get that information right on the label to make people more conscious about it and make companies more conscious about it as well.

Mr. Lawrence: Earlier, you mentioned the development of the strategic plan and its context at FDA. Could you tell us about the process and the results of that?

Dr. McClellan: I will. This is actually very important element of my approach to working at the agency. Before I even officially came on board, after my confirmation, I went on a retreat with the agency's senior professional leadership, the dedicated staff that had been there for many years and, in most cases, working on the difficult problems that FDA has to face. We spent a couple of days; we got together to figure out what our top priorities for the agency are. You know, what do we really want to get accomplished in the coming months and years? And through that process, we got to consensus on five key areas where the FDA, we believe, needs to focus its efforts.

First, from an internal standpoint, is having a strong FDA. We need investigators and reviewers and other staff who are well-trained and up to date in the best techniques for doing their job.

A second key priority is what we call efficient risk management. And that's kind of a mouthful, but again, as we talked about earlier, our main goal at the FDA is to reduce the risk that people face, both the safety risks in the products they use and the risks of diseases and other health problems that using new drugs or eating a good diet can help reduce as well. And we want to find the most efficient way to reduce these risks. So if we've got a regulatory challenge, what we're increasingly trying to do is go through a careful analysis of what the risks involved are, go through a risk management review of how we might manage those risks, and then ask the question about efficiency. What's the least-cost way of getting the risk facing the public down? Least cost to us because we have limited resources, but especially least cost to society. We don't want to impose any unnecessary costs on medical products or on foods because people are struggling today to afford these products. So that's a philosophy that we have applied in many of the things that we're doing at the agency now, from the improvements in our review processes for drugs and medical devices to our new strategy for food security in the country. In many, many areas, we need to apply the principles of efficient risk management.

And then we decided that there were three other areas where we particularly wanted to focus. One is in patient safety, reducing the adverse events that people may experience in using the products that we regulate, and we've already talked a little bit about that. I think adverse events are way too common. There are tremendous opportunities for reducing costs in health care and improving the public health by adopting new approaches to help make medical care and the other products that we regulate safer and easier to use.

A second key area is consumer information. For all that the medical technologies that we regulate can do and for all the regulatory protections we provide, the most important impacts on the public health, any public health expert can tell you this, come from people's own choices about their diet, their lifestyle. The choices that they make can have big impacts on the public health. And so the more that we can do to help make sure that consumers are making those choices based on good and up-to-date science-based information, the more we think we can promote our mission of protecting and improving the public health.

And finally, as we've already talked about as well, countering terrorism has got to be a top priority of just about all of the agencies in government today, especially for one like us that is so involved in food safety and food security and also so involved in getting more effective treatments to the population. We were way behind in medical technology for the agents of terrorism, and we're taking major new steps to bring that up to date.

By going through the strategic planning process and working from these large goals to some specific performance objectives, results-oriented objectives, I think it's helped us work together much more effectively, given our limited resources, on what people in the agency think as well as our constituents think are the most important public health problems for us to address.

Ms. Morin: Mark, as I recall, when you took on your role as commissioner, you indicated that one of your major focus areas would be human capital management.

Dr. McClellan: Yes.

Ms. Morin: What has the FDA done in this area?

Dr. McClellan: Well, the FDA is already starting from a fairly strong spot. The Washingtonian magazine last year rated FDA as one of the top government agencies for jobs and for lifestyle, and there are a lot of reasons for that. We've been leading the way, I think, in a number of innovative programs, like a flexible place workforce. About 20 percent of our workforce telecommutes for a significant part of their work effort. We also have a flexible hours program, an any-80 program that allows people to work their schedule around important outside constraints, young kids, parents that might need help, other challenges in other parts of their life. These kinds of steps help us attract some of the better and retain some of the better talent out there.

We've also tried to use flexible hiring procedures. There are so-called Title 42 approaches that enable us to offer performance rewards to some of our best scientists to help attract and retain them, steps like that to make this an attractive place to work. Recently, we've also tried to expand our training programs, our E-learning programs and the like. And we're taking a number of others steps, such as new surveys, performance-oriented surveys, by the Gallup organization and others to try to link workforce satisfaction, the satisfaction of our workers with their job, to job performance, because I think there's a tremendous amount that can be done there. If we have people who are working hard and are enjoying their work, we're going to get a lot more done.

Mr. Lawrence: What's FDA doing in the area of E-government?

Dr. McClellan: Well, we talked about a number of steps already. Many of the innovations in training programs and the like are happening over the Internet. And overall in fulfilling our mission, there are tremendous gains to be had from increased reliance on modern information technology; just as, for example, we're trying to move towards electronic submission of the product applications coming into the agency. Some of these product applications for new drugs may be literally 100,000 pages or longer in length. And getting those records on paper is both burdensome to our nation's forests and burdensome to our staff to be able to track down the documents. Not only that, there is a tremendous amount of information in these reports that can potentially be used by the agency to get insights into how to make the regulatory process work better. If we can compare across applications more easily, we can see patterns that might enable us to provide clearer guidance to industry and to product developers about how they might take steps to reduce the cost and the uncertainty in the development time. So we're trying to automate all of these processes.

I've already talked about some of the steps that we're taking on patient safety as well by relying on the electronic health information systems outside the agency in the nation that are increasingly becoming more and more sophisticated. We can learn more about medical practice and potential safety problems that ought to be influencing our decisions about product regulation. So there's a lot to be gained from E-government activities at FDA.

Mr. Lawrence: That's an interesting point, especially about all the paper.

So much of what the FDA does involves the work between government, industry, health, and education. What are the best practices coordinating and collaborating?

Dr. Mark McClellan of the FDA will give us his insights when The Business of Government Hour continues.

(Intermission)

Mr. Lawrence: Welcome back to The Business of Government Hour. I'm Paul Lawrence, and this morning's conversation is with Dr. Mark McClellan, commissioner of Food and Drugs.

And joining us in our conversation is Therese Morin.

Ms. Morin: A lot of the work FDA does relies on working with partners in government as well as in industry, health, professional, and education institutions. How difficult has it been coordinating these issues, and what steps has FDA taken to ensure cooperation?

Dr. McClellan: Therese, I found it not that difficult because it is so clear what the advantages of collaboration, both within government and outside government, are for many of our activities. What's very important is to be clear on the goal. And I found very little difficulty in working with other agencies in many of our goals.

For example, in one of our recent announcements on health claims on food labels, which we were just talking about, we have worked closely with the Federal Trade Commission, which has a lot of expertise in advertising regulation and in understanding how consumers interpret information that they get on products. We're working closely with the National Institutes of Health on that effort. They have a lot of expertise and are funding more studies on how consumers understand scientific information. That's one set of examples.

Another big area of coordination for us involves the development of new medical technologies. As the NIH budget has doubled, the NIH has become more concerned and interested in ways to make the clinical research process more efficient. And that intersects directly with our goal of reducing the time for development and approval of safe and effective medications. So for example, the director of the National Cancer Institute, Andy von Eschenbach, and I announced in May a new set of collaborations between the FDA and the NCI to speed the development of safe and effective cancer drugs. That includes coordination with us on adverse event reporting. It includes better support for FDA-mandated so-called Phase IV studies that are done after products are approved, to give us a better idea about the long-term risks and benefits to confirm that they're exactly as we suspected they would be when the product was approved. Steps like that I think are increasingly common across government agencies.

And also, following on this same issue of developing new medical technologies more efficiently, we are right now holding a series of public workshops and comment periods on ways in which we can make our approval standards perhaps more efficient and up to date in new and emerging areas of technology. For example, in cell and gene therapy, there have been a tremendous amount of research studies conducted, a lot of clinical trials underway; some that have had setbacks, but a lot of potential. As of yet, however, there are no products that have been approved for use in patients on general terms. So we're trying to work with outside experts in product development as well as with the experts at NIH in making sure that we've got the clearest, most efficient regulatory pathway laid out for product developers in these emerging areas.

Ms. Morin: The FDA also has involved stakeholders and a series of advisory committees. Can you tell us about the involvement of the stakeholders and the work of the advisory committees?

Dr. McClellan: Well, the advisory committees are extremely important in giving outside, independent, up-to-date scientific advice to the agency. We have well over 30 advisory committees, 300-plus members on them, and a number of other external advisors that work with our advisory committees on specific issues, literally in the thousands. So this kind of expert input is extremely important for us.

But as you all pointed out before and as we've discussed already, the things that we do touch the lives of Americans in just about all segments of society. I think something that we do is of interest to everyone in this country. And so we try very hard to have other outreach programs as well beyond our advisory committees to make sure that we're hearing from consumers about what they think we should focus on. We've got special programs for women's health groups, for minority health, and the like to make sure that we aren't failing to address the needs of specific populations appropriately. This kind of external interaction and input is extremely important for us doing our job effectively.

Mr. Lawrence: Well, FDA's part of the Department of Health & Human Services, and there's a move to create I guess it's called One-HHS. What does that mean to FDA?

Dr. McClellan: It means that we have some new opportunities to fulfill our public health mission more effectively. Secretary Thompson has been a strong proponent of the One-HHS idea because he believes, and I think he's right, that we can do our job more effectively if we're coordinating and leveraging off work in other agencies throughout the whole department. Just to give you a few examples of this, one of the top priorities department-wide now is patient safety. And so there are many things underway at CDC for better monitoring through the public health networks of potential safety problems; many programs underway at the Agency for Health Care Research Quality for improving the data and the data systems that we can use to understand patient safety issues. And those obviously have a lot of interest to us as well at FDA on how we can improve the public health.

So I think there are a lot of opportunities through the One-HHS approach for us to do our job more effectively rather than have, for example, one separate system that relies on electronic reporting and surveillance for CDC of events happening in emergency rooms that they need to know about for the occurrence of public health outbreaks. We ought to be interacting with them so that we can get information from the same kinds of systems about problems that might involve drugs or devices that we regulate or problems that may be reflections of a food-borne illness outbreak. Lots of opportunities to work together effectively.

Ms. Morin: What are the next major challenges on the horizon for the FDA?

Dr. McClellan: We have a huge number of challenges, and you all have touched on many of them already in our discussions. We need to keep improving our food security in this country. Our food supply is safer and more secure than it ever has been, but there are some real threats out there that we need to do more to address. The opportunities for improvements in biomedical technology are great. A lot of people think this may be the biotech century because of all the potential breakthroughs in genomics and nanotechnology and other technologies that may enable us to cure, at least hold off, serious chronic diseases, like cancer and Alzheimer's.

But again, we haven't seen those treatments demonstrated to be safe and effective for patients yet, despite all the promises. And it's getting extremely costly to develop and bring these new technologies to market, and we're facing some real problems in the affordability of health care. I thought those are some critical challenges that FDA can help address.

And I'd like to come back to the other element of our other specific key area in our strategic plan, which is consumer information. There is more today known about what consumers can do to improve their health than ever before. But there's so much information out there, some of it from unreliable sources, that I worry about consumers being able to get an accurate assessment of what the latest science has to say so that when we tell them that, you know, there are steps that they can take to improve their health and they go out and want to do it, they end up spending their time and effort and money in the right ways rather than on potentially wasteful products that make misleading claims, or potentially wasteful products that they've read about somewhere and it's just not accurate, reliable information.

So those are all areas where we're facing new challenges. And as we head into the FDA's second century, I can't think of a better and more interesting place to work to help improve the public health.

Ms. Morin: So based on all this, what is your vision for the FDA in the next 5 to 10 years?

Dr. McClellan: We are looking forward to playing I think even more of a role in promoting and protecting the health of the public. We have some new opportunities and new challenges in protecting the public health. Counterfeit drug technology is getting more advanced, for example, and we've touched on a number of other problems on the side of promoting the public health, on advancing the public health, the opportunities on both the food side of our mission and the medical side of our mission are greater than ever. I have a vision of the FDA that is using the best and most up-to-date science as efficiently as possible to help Americans make effective decisions, to help make sure that the products that they use are safe and effective, and I think there are more new opportunities to do that than ever before. It's a great place to work.

Mr. Lawrence: Mark, you have a very interesting background and you've been drawn to public service. I'm curious, what advice would you give to someone interested in a career in public service?

Dr. McClellan: Do it. It is a great time to be in public service. We are facing some real and difficult challenges in this country, some unprecedented challenges, and terrorism and new science and the like, and there are better tools out there to use to meet these challenges than ever before.

But I would like to emphasize that public service doesn't have to be a lifelong decision. Many of our staff have spent some time in industry, some time in the private sector before coming here. I was in academics up until just a couple years ago. And many people work for a while at the agency and then move on to other kinds of jobs in industry, doing consulting, and the like. And a lot of people have said, well, you know, some turnover at FDA isn't that bad, you know. Don't you want to retain people for a career? And I certainly would like to keep people who are doing a terrific job in public service as long as possible. But I don't think you need to view this as a lifelong decision.

I think there are a lot of interesting ways in which you can spend some time working for an agency like FDA, understanding how the government works, making a real contribution to the public health, doing the right thing, in addition to having a great career in the private sector at other parts of your life as well. It's not an either/or decision, and I would encourage people who are interested in science, who are interested in policy to think about an agency, spending at least some time at an agency like FDA in the course of their career development.

Mr. Lawrence: I'm afraid we're out of time today, Mark. Therese and I want to thank you for fitting us in your very busy schedule.

Dr. McClellan: Great. I'd like to just make one more plug for the agency. We have a very extensive website that can help you learn more about the many areas where we are engaged in new activities and also learn more about opportunities for working at the FDA. We're always hiring. It's www.fda.gov.

Mr. Lawrence: Thank you very much, Mark.

Dr. McClellan: Thank you.

Mr. Lawrence: This has been The Business of Government Hour, featuring a conversation with Dr. Mark McClellan, commissioner of Food and Drugs.

Be sure and visit us on the web at businessofgovernment.org. There, you can learn more about our programs and research and get a transcript of today's fascinating conversation. Again, that's businessofgovernment.org.

This is Paul Lawrence. Thank you for listening.

Dr. Mark McClellan interview
12/27/2003
Dr. Mark McClellan

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