Food, Drugs, Medical Devices and the Public Interest

GUEST: Dr. Margaret Hamburg
AIR DATE: 05/01/10

I’m Richard Heffner, your host on The Open Mind.

And in a nation whose major political mantra has for too many years now been “Deregulate, Deregulate, Deregulate”, the brilliant, balanced and articulate physician who is my guest today is also in her way America’s chief regulator.

For as our new Commissioner of the Food and Drug Administration, Dr. Margaret Hamburg now presides over an often besieged federal agency that regulates products reportedly representing as much as a quarter of all the consumer dollars spent in America.

Which may well mean that now, or later, my rational, reasonable – yet tough! – guest is going to have to stand up to as much as a quarter of the enormous economic and political pressures that this great nation of ours can — and frequently does — summon up for one major vested interest or another. And stand up to them, I’m sure she shall.

Which leads me to ask Dr. Hamburg a question I haven’t put to an Open Mind guest since Dr. David Kessler, her intrepid predecessor as Commissioner of the Food and Drug Administration was here a generation ago: namely, what does she most want to be asked, so that in her responses we’ll best learn her priorities in this regulatory position so vital to the health and well-being of every one of our viewers. What questions would you most appreciate?

HAMBURG: (Laughter) Well, I guess the question of why is FDA so important? It’s a very special, very unique and very important agency for the health of all Americans, yet I think it truly is underappreciated, has been dramatically under-resourced for many years and I think this is a crucial moment, to make sure that this agency is well equipped and fully functional for the 21st century.

HEFFNER: How well resourced is it now?

HAMBURG: Well, it’s gotten better. You know, over many years it’s had its ups and downs and as you say, its sometimes been the victim of strong political pressures, anti-government feelings, etc.

It also tends to be an agency that … when we’re doing our job well, people don’t notice because there aren’t problems and then when there are problems, everyone likes to jump down our throats, bash us and, and then abandon us. So I think this is really an important time to help people understand what we do, how we do it, why it’s important.

I want to restore full trust and confidence in the FDA. I want to make sure that we’re equipped, scientifically, to meet the challenges of this century. And to function in what is now a very globalized world.

HEFFNER: What do you do? How do you go about dealing with a quarter … if that figure is accurate … 25% of what consumers …

HAMBURG: MmmHmm.

HEFFNER: … in this country spend their money on.

HAMBURG: Well, FDA is responsible for a vast array of product … food, drugs, medical devices, dietary supplements, animal drugs and animal feed, certain products that emit radiation and now, as of this past summer, we have the responsibility for regulating tobacco products as well.

So we’re responsible for a vast array of things. Products that people count on every day, whether it’s the toothpaste that you use in the morning and at night. The medicines you take, the sunscreen you put on, the food you eat. We really do make a difference every day to so many people. And so it’s, it’s a huge, huge job. And it really means that we have to be operating on a number of levels in order to be successful, in order to earn the trust and confidence of the American people.

HEFFNER: Should I feel safe and secure in knowing that Peggy Hamburg is there …

HAMBURG: (Laughter)

HEFFNER: … at the FDA?

HAMBURG: Well, of course, it’s not Peggy Hamburg, it’s not the FDA Commissioner. It’s the extraordinary group of, of employees at the FDA that make the important difference and make the FDA function in ways that, that … as I said … you know, really matter to people.

We’ve got an extraordinary array of doctors, scientists, public health specialists, lawyers, inspectors, policy analysts. And, of course, the support staff that actually are the glue that hold us all together.

But one of things I’ve been really impressed with since I’ve been there, and it’s been almost a year that I’ve been in this role … and, you know, I would say the secret resource of the FDA is its dedicated staff.

HEFFNER: Is the feeling of frustration on the part of that staff, which has been reported on, whether accurately or not, I can’t judge … but you can … is that feeling diminished now?

HAMBURG: Well, I would like to think so.

HEFFNER: Should it be?

HAMBURG: I think that it’s true that there’s been low morale in the agency. It’s been in recent years an agency that has been the target of a lot of scrutiny. You know, yes there have been some incidents … drug safety concerns … food borne outbreaks and other things that have, have caused the media and policy makers to pile on at times.

But I think if you look at the day-to-day work of the agency, it really has been extraordinary and the track record of, of safety and commitment to making important products available to people while undertaking important science based review of new medical products and, and inspecting facilities that produce foods, drugs, medical devices, whatever … you know, it, it really impresses me what people have been able to do.

But I recognize that they have been the target of a lot of … of barbs and arrows and that that led for a period, I think, to sort of circling the wagons, not wanting to stick their necks out, reluctance to take risks in certain instances.

And I think that, that now they know that they do have a leader who believes in the mission, believes in them and that will, will speak out for what the agency needs. And I think that’s key.

HEFFNER: Well, neither you nor your colleagues function in a vacuum. You’re in Washington, all of those pressures that come from Washington …

HAMBURG: Right.

HEFFNER: … and from parts of Wall Street and everywhere else in this country. How do you … what’s the criterion, essential criterion that you use as you stand up to them, or …

HAMBURG: Right.

HEFFNER: … go along?

HAMBURG: Well, it’s, it’s a very good question and certainly I think in a job like this you have to have a compass, an internal compass that guides you.

And for me that’s public health. I’m trained as a physician, but most of my career has been in public health and my commitment is to do everything I can through my professional work to enhance the health of the public. To protect the health of the public, to prevent disease and to promote health.

And FDA is a science based, science driven regulatory agency with a public health mission. And that is my guide.

HEFFNER: You mentioned a few minutes ago … tobacco …

HAMBURG: MmmHmm.

HEFFNER: … as coming under your rubric or egis … why not ban the damn stuff.

HAMBURG: (Laughter) Well, that’s a decision that Congress has to make. And they debated it. We all understand, I think, that tobacco products represent a huge public health challenge. Tobacco and smoking represents, you know, really the leading cause of, of disease and death in this country. And it’s a global problem as well.

So it’s very important that we move forward to address that concern. The law gives us new authority, really it’s a historic step forward to oversee and regulate aspects of, of tobacco product manufacturing. What can be in tobacco products. The distribution of tobacco products. The marketing of tobacco products.

And with those new tools and authority we will make a difference in terms of reducing existing smoking and, importantly, helping to prevent youth from taking up this addictive and deadly habit.

So I, I, I’m very excited about this public health opportunity that we have. We’ve been moving swiftly to put this new program into place. The law was passed this, this last summer, in June, and we have geared up and begun to implement different components of the law.

And what we do is very, very important. It’s a piece of a bigger puzzle in terms of, of other actions. Educational and treatment that needs to go forward to really address the problem of, of tobacco and its deadly impact.

HEFFNER: What, what differences will we see because of your new authority over tobacco?

HAMBURG: Well, for the first time we will really be learning a lot about the content of cigarettes and what’s done to make cigarettes more addictive and, and to also make tobacco less noxious to potential new smokers.

Because tobacco itself is pretty abrasive as a substance. So things are added to the tobacco and to, to cigarettes in order to make it easier to smoke and then become addicted to the nicotine.

So already we’ve banned fruit flavored and, and spice flavored cigarettes.

HEFFNER: As being too attractive.

HAMBURG: Because we know that it’s attractive to, to young people. And if you start smoking as a, as a child or early adult, you’re much more likely to smoke for a lifetime with all of the attendant medical complications of that. So we want to stop kids from taking up the habit in the first place. And then we also want, of course, to provide more information and opportunity for people who are already smoking and addicted to stop the habit.

HEFFNER: Does this mean that you’re faced with an industry that is doing everything in its power to lure kids into the addiction of smoking?

HAMBURG: Well, I think the industry has been very entrepreneurial in how it addresses (laugh) tobacco products. And we have seen a series of new products that are quite worrisome … lozenges that are packaged and look almost like candies and are flavored accordingly. Fruit flavored cigarettes, as I mentioned. Small packages that are cheaper, that can, can be more accessible to young people.

So we’ve certainly seen a number of ways in which the industry is sort of reaching out to young people and that’s a worrisome trend.

And this new authority that we have in terms of our regulatory powers will enable us to address that and hopefully, really limit how tobacco products are both manufactured and marketed in terms of, of trying to stem the epidemic amongst children.

HEFFNER: Do you expect that new authority to be challenged?

HAMBURG: We’re already been sued three times. Yes, we expect that as, as this program goes forward we will have to deal with litigation. But we are implementing the law of the land. We will do it as responsibly as we possibly can and as openly as we possibly can and we will defend our actions in a court of law if we need to.

HEFFNER: Do you have any concern that even with a Congressional mandate your authority won’t stand up?

HAMBURG: Well, already we have been reinforced by the courts in, in actions that we’ve taken and so that, of course, is encouraging.

You know, as I said, we have a responsibility to enforce the law. And that’s what we’re doing and will continue to do that. And I hope that, that we won’t have to fight every issue in the courts.

We’re trying to work with industry. We have a scientific advisory board that has industry membership on it, they’re non-voting members. But we want to hear their perspective. We’ve done listening sessions with different key stakeholders, including industry.

But this is an issue that has a huge impact on health. We have a legal mandate to act and so we are, of course, pursuing that.

HEFFNER: This isn’t a legal mandate that has been pressed upon you, is it? It’s one that you welcomed.

HAMBURG: I welcome it and I think that the FDA is the right agency to be in the lead. At the time that I was first nominated, it wasn’t yet law, Congress was starting to debate it and of course, it’s been an issue that’s been around for quite a while.

David Kessler, a former FDA Commissioner, started some of the early discussion about FDA’s role in regulating tobacco products. And was a real pioneer.

But, you know, there were concerns raised. The FDA already has such a huge array of responsibilities, is already cash strapped in key areas.

People said, should we give this new responsibility to the FDA? Can they possibly take it on? Can they possibly successfully implement new mandates?
And, you know, my response, when asked, was that this was such an important public health priority and this is a regulatory issue with huge public health implications.

FDA is a science based regulatory agency with a public health mission. There is no other agency like us. I think the regulation of tobacco belongs with FDA and so far I think we’re doing an excellent job implementing this new law.

HEFFNER: You have several times used the phrase “science based” …

HAMBURG: Yes.

HEFFNER: Why?

HAMBURG: Why science based?

HEFFNER: No. No. Why do you emphasize that ..

HAMBURG: Emphasize it?

HEFFNER: … so much.

HAMBURG: Well, because it’s true, number one. Because we sit in a very, very critical position where we are responsible for reviewing and approving or disapproving new medical products, an array of other products that have the potential to really benefit the public.

We have to assure safety and efficacy of, of medical product. We have to help … be a gateway … for discovery and innovation as the result of advances in science and technology to the public. We can’t do that job well if we don’t have strong science within FDA in order to review those products, in order to help define what are the studies, what’s the evidence base, in order to approve or disapprove a new product. So it’s absolutely essential that we be science based.

It also, I think, is very, very important that we be a data driven agency. Some of our decisions are very, very tough. There isn’t always an absolute “yes” or “no” answer. And politics and social values and economics all are swirling around the decision making and again, you have to have a compass to guide you through sometimes turbulent waters when making important decisions for the health of the American people.

And for me, it’s public health, how is it going to affect real people in the real world and the best way to make those decisions is to be data driven with a strong foundation in science and to ensure that we have the data we need and the scientific expertise, internally and working with external partners, to make the best decisions possible.

HEFFNER: You say your, your mandate obviously includes, not just protecting, but helping innovate …

HAMBURG: MmmHmm.

HEFFNER: … opening up, not just establishing …

HAMBURG: Right.

HEFFNER: … gates against the wrong things.

HAMBURG: Right.

HEFFNER: How do you make that bet? How do you make those decisions …

HAMBURG: Yeah.

HEFFNER: … that take safety in numbers and the whole matter of innovation …

HAMBURG: Yeah.

HEFFNER: … of making a bet on something?

HAMBURG: Well, you know, throughout a lot of the history of FDA I think people have sort of looked at it as either you support innovation or you support safety.

HEFFNER: MmmHmm.

HAMBURG: But I think that we have to find a way to merge the two. It’s critically important that we harness and take advantage of all of the advances in biomedical and life sciences research today in science and technology to benefit the public.

But we also want to make sure that new products are safe. And of course, that they’re actually effective. And so we do sit in this, this, this pivotal position. We also sit in a pivotal position in terms of … we can look out on one side and see what’s in the pipeline, see what’s happening in terms of discovery and innovation or we can look out on the other side and see what’s happening in terms of unmet public health need.

And I think we have a responsibility to try to marry those two issues, to try to move innovation and product development to help address some of those unmet public health needs. And I think we’re trying to do that as well.

It’s been a very exciting time and a very exciting role in that regard.

HEFFNER: And the guess the buck stops right here.

HAMBURG: Well, you know, as I said, I stand on the shoulders of many and it is really remarkable the dedication and the expertise of the FDA staff. It’s also been very heartwarming to me on the outside how many people want to help. You know, I thought when I took this job that it might be the kind of job where everyday I’d go to work and be beat up for the things we were doing wrong and the, the problems we hadn’t fixed.

But instead, you know, what I have really found is that across the whole range of stakeholders in the work of the FDA that, that people really want to help.

I think people have come to appreciate the fact that as a nation we really need a strong, fully functional FDA. That we’re a unique and important agency and that if we can’t do our job and do it well, that there isn’t any other part of government or private sector entity that’s going to step up and back stop behind us.

And so, I, I’ve really felt a lot of support and a lot of eagerness to help. Whether it’s patient groups and consumer groups or the scientific and public health community, or industry.

HEFFNER: Talking about industry. I asked to begin with, what questions you wanted me to ask. This didn’t come among them, but it’s something that concerns me. And I remember it entered into my discussion with Dr. Kessler so many, many years ago. What about drug advertising?

HAMBURG: Well, that’s a complicated challenge. And I have to say I was surprised to learn that we are only one of two nations in the world that do direct to consumer prescription drug advertising.

HEFFNER: What’s the other one?

HAMBURG: New Zealand.

HEFFNER: New Zealand.

HAMBURG: Yeah. You know I think we can do better. And I think it’s an important challenge to industry to find ways to, to take advantage of the opportunity of direct to consumer advertising to actually educate the public about some of these diseases and the disease condition and not just try to sell a product.

And I think that, you know, it can be a slippery slope in terms of when you go out there to, to sell a product you, you … even though, yes, they list all the complications and everything, there also is, obviously an effort to recruit people into wanting to use the product and, and making them believe that perhaps the product will actually do more for them. And so I think it’s an area we have to monitor closely. It’s an area where, again, we haven’t really had all the resources that we need to be as proactive as we should be …

HEFFNER: What do you mean?

HAMBURG: You know, we have a very limited number of people that are reviewing the, the advertisements …

HEFFNER: I see.

HAMBURG: … and, and we, we can’t move as quickly as we should in terms of when there’s problems to identify them and work with the companies.

You know it’s my hope that over time, you know, we’ll be able to have some really good conversations with the industry about where we are and where we need to be going. Because I think we all recognize that the current situation is, is, is really almost embarrassing in some ways.

The products that are chosen to be advertised and how they’re advertised and, you know, I think that, as I said, there is an opportunity to do a better job using the resources of industry not just to advertise a product, but to also educate the public and I hope we can move a bit more in that direction.

HEFFNER: There’s going to be a long silence because I don’t know what to say with that. I wonder, indeed, if I were asking you as a physician … you are a physician …what you think about prescription drugs being advertised on the air. I wonder what your response would be?

HAMBURG: Well, it’s been a while since I’ve been in practice, but I think it’s a plus and a minus. It does alert physicians to new drugs that might be on the market that they haven’t encountered, etc.

But it also means that patients are coming to them wanting drugs that they’ve seen advertised that may not, in fact, be the right products for them. And frankly it’s not just the direct to consumer advertising, it’s the Internet as well. Which is a mixed blessing. You know, it gives consumers an opportunity to get access to a lot of important information that can help them do a better job making important choices for individuals and their families concerning their own health.

On the other hand, there’s a lot of unscreened information that’s available that is of varying degrees of accuracy. And so, physicians and health care providers are now in the position of having to try to stay a step ahead of patients in terms of, of knowing what all is out there and really having to address a lot of mis-information as well as the benefits of patients being able to access good information, as well.

HEFFNER: As far as you can tell in the year you’ve been in this position, which way is it going? Do drug commercials, prescription drug commercials, in your estimation … the estimation of people who work with you … someone’s waving a flag at me that says we have one minute … do they look as though they’re going more in the direction that you think they should go in?

HAMBURG: I think it’s an area, you know, that we still need to work on together.

HEFFNER: The … you and the industry?

HAMBURG: Right. I mean I think that we need to, to really try to develop a strategy that one, I think FDA continues to me to build its capacity to monitor and review advertisements. I think the industry needs to step up to the plate a bit more in terms of, of its responsibilities more broadly.

And I think we have to address the growing challenge of Internet advertising, which is very, very hard to regulate and control.

HEFFNER: I’d love to address that with you and the next time you’ll do a program with me, now or at some other point, I hope we will talk about that.

Thank you for joining me today, Dr. Hamburg.

HAMBURG: Terrific. My pleasure.

HEFFNER: And thanks, too, to you in the audience. I hope you join us again next time. Meanwhile, as an old friend used to say, “Good night and good luck.”

N.B. Every effort has been made to ensure the accuracy of this transcript. It may not, however, be a verbatim copy of the program.