Full article reprinted from The RPM Report July 21, 2009
FDA is entering a new era of refined regulatory tools and an expanded regulatory umbrella that includes tobacco products. Drug manufacturers have witnessed a more activist FDA compared to the previous administration under the leadership team of Commissioner Margaret Hamburg and Deputy Commissioner Joshua Sharfstein.
Hamburg addressed a variety of issues during a press briefing including whether the agency will revisit drug safety decisions that left some riskier drugs on the market, the impact of tobacco regulation on drug and biotech regulatory operations, FDA’s drug marketing and promotion policy, and her working relationship with Sharfstein, among other issues. Read more...
Full article reprinted from The RPM Report July 21, 2009
The new commissioner, with just over a month on the job, believes providing strong leadership combined with demonstrating science-based decision-making are key to restoring the agency’s credibility and turning around its public image.
(The questions were posed by multiple media organizations including The RPM Report and were edited for clarification.)
Q: How do you make sure you have time for getting up to speed on the wide variety of issues under FDA’s regulatory umbrella while simultaneously dealing with the next crisis which is just around the corner?
Margaret Hamburg: I can tell you I don't have any time to eat lunch. I've really been in a mode of collecting information and learning, still asking the dumb questions, but really having the chance to be exposed to the really extraordinary range of activities here at the FDA. I didn't fully appreciate just the depth and breadth of both activities and expertise that resides here.
Q: What surprised you the most about the FDA, and perhaps what's been your biggest disappointment or frustration so far?
Hamburg: I have been very struck by both how complex an agency this is, but how it really is driven by a very clearly defined and central mission, which is to promote and protect public health. The mix of people is a very highly professional group—scientists, lawyers, public health professionals—and people work hard, and they really do care. And that's been very encouraging to me, and I've felt an enormous amount of support coming in, and a sense of real opportunity. But it's not an easy job.
Revisiting Drug Safety Decisions
Q: I was curious whether you're going to revisit previous agency decisions to keep drugs on the market despite a lot of public concern that their risks may outweigh their benefits, or are you planning to let those decisions stand as barring any significant new scientific information?
Hamburg: I hope that my leadership will be marked by a strong and clear emphasis on science-based decisionmaking, and that if there's a question about a drug on the market, I would be looking at it in terms of what is the available evidence—is it safe and is it effective—and if there are concerns about its safety I would have no hesitation about examining it more closely and taking action.
Q: First, on your past experience with Deputy Commissioner Sharfstein, have you ever crossed paths professionally? Second, what are your thoughts on the perception that FDA has lost a lot of institutional knowledge over the last several years?
Hamburg: I had not had the opportunity to work directly with Dr. Sharfstein, although we both share in common a couple of key features of personal and professional life. We both obviously were local health officers, and that's an important bond. We also are both the children of psychiatrists, for better or for worse. People have noted that, although I don't think it's highly influential in terms of how we ended up working together.
But I'd heard of him and his work, and I must say I've enjoyed working with him in this role, and he's been very helpful both in terms of being able and willing to come into the agency earlier than I, since I did have to go through the confirmation process. I think we are proving to be a pretty effective team.
With respect to the question of institutional expertise, I have to say I value that enormously and appreciate what people like Janet Woodcock and Bob Temple bring to bear. There are many others with that deep expertise and understanding of the institution over many years and many health commissioners. It's quite striking that people come and stay at the FDA.
But I think looking forward not only do we have to appreciate and support the institutional expertise, but we really have to build new expertise, as well. I see a very important part of my mission here as trying to strengthen the scientific and professional base of the agency, recognizing that as time goes by, there's a range of new challenges, new challenges that are brought on both because of the very dramatic and rapid advances that we're seeing in science and technology that really require us to make sure that we have expertise in certain key areas and strong understandings and partnership with both industry and research, the research community, and also globalization.
FDA needs to make some significant strides forward in terms of really being able to accomplish its mission in a globalized world, and I'm going to be putting a lot of time and attention into how to define strategically where our global footprint needs to be and how we're going to accomplish that.
Dealing with Tobacco
Q: In the few weeks that you have been at the agency there's been a great deal going on. There's new legislation moving through Congress for food oversight, and FDA will now regulate tobacco. I'm wondering if you feel that this is really overloading the agency's plate at a time when you have so many other challenges before you.
Hamburg: I don't think it's overloading the plate. I think that it is really providing us with the tools and authorities that we need to do in order to address really important public health problems. There is no doubt that tobacco and tobacco products represent a huge burden on health. It's been probably the number one killer in this country and around the world. And so I think it's very appropriate that FDA, which is a science-based public health regulatory agency, take on the challenge of regulating tobacco and doing what needs to be done to help reduce the enormous public health threat.
Clearly, FDA, from its earliest days, has had a responsibility for dealing with issues of food safety, and those challenges have only grown as the food production system has gotten larger and more complex and highly distributed and as we've entered the global era and we're talking about very large percentages of the American food supply being imported from overseas. So we absolutely need to take on those challenges in the case of food, to strengthen what we're doing.
But the drug and medical product area is core to our mission, as well, and I do not see us in any way stepping away from that important component of our activities. And I personally am looking forward to delving into those more. One of my earliest loves was biomedical research, and I did research in neuropharmacology before I started medical school and during medical school and some additional research in neuroscience later at Rockefeller University. So I'm eager to also really get more involved in addressing the issues of innovation. How can FDA be a real partner, not a hindrance, in terms of really maximizing all of the advances going on in life sciences research today and in biomedical technology?
My hope is that we will be able to have the resources we need. That's a key concern. But we will be able to have the resources to attract and retain the expertise we need and really build on good work that's going on but extend into new areas.
Q: With the advent of a new tobacco center, do you anticipate any major reorganizations in the agency? They're getting a lot of centers now, and there has been talk also about reorganization related to food safety.
Hamburg: We will clearly create a new center for tobacco, but it will be a discrete undertaking. I think it will benefit from work going on elsewhere in FDA in terms of strategies for regulation. But it, I don't think, signals that we're going to suddenly be spinning off all kinds of other centers and activities. We remain rather streamlined compared to our sister agency, the National Institutes of Health, with all of its institutes and centers.
FDA’s Next Challenges
Q: FDA has been referred to as an agency in crisis. What do you consider as FDA's challenges overall?
Hamburg: We don't lack for challenges. It's a complex agency working in a complex arena at a complex time. In terms of challenges—and I don't mean this to be in priority order, necessarily—but I think clearly strengthening food safety is a very high priority where we have a number of critical actions that need to be taken in order both to strengthen food safety domestically and also really take on the international challenge.
The international challenge looms very large with respect to drugs and medical products, as well, so I guess I would say that a second major challenge is really moving FDA into the 21st century and addressing the global issues, and defining strategically what our global footprint needs to be.
We have a historic opportunity with respect to all that's going on in life sciences research and really a responsibility to make sure that we are mobilizing the advances in science and technology as effectively as possible in how we do our job in terms of regulation, review and oversight, and also working in partnership with innovators to enable important new discoveries to actually be developed into promising new products and efficiently and swiftly reviewed so they can get out to the people who need them.
We cannot ignore the priority that tobacco will become in terms of the FDA activities. Standing up a new center and taking on these new responsibilities is very key. It will be looked at as a measure of FDA's leadership, and so I take that very seriously, as well.
So there's no doubt that I will be juggling. But I think that we are uniquely positioned to address really important public health problems that affect people's lives every single day. And I think that there's a level of support for the FDA which, frankly, even surprised me.
I took on this job knowing that there was a lot to worry about and that it was probably going to be the most difficult professional challenge that I'd ever taken on. But I was very, very heartened once the announcement was made by the number of people in the scientific community and in the public health community that reached out to me and said, "FDA is a unique and important agency. Anything I can do to help."
When I did my visits up on Capitol Hill as part of the confirmation process, I thought I was going to hear a lot of FDA bashing, but instead what I heard over and over again is: “I really care deeply about FDA. It hasn't gotten the resources and attention that it needs. I want to work with you. I want to support you. Please know that my door is open.”
And I think that the general sense within the agency, as well, is one of really feeling very deeply the importance of the mission of FDA and that their work makes a difference. And so I feel it's complicated and there are lots of daunting challenges, but enormous opportunity to do some good.
Q: How many FTEs would the new tobacco center take to staff and how do you address the industry's concerns that it will drain people away from some of the other centers, particularly the drug center, and might further impact on the speed of drug reviews?
Hamburg: We're still developing the staffing plans and the rollout in terms of creating this new center. But I am very, very pleased that the legislation was written with the resource issues in mind, and we do not anticipate that there is going to be a need to take resources from other areas. We do not think that it will be taking away in any sense from the other critical missions of the FDA.
Q: You don't expect people to be moving from one center to the other?
Hamburg: I think that we will be hiring on a lot of new staff. There may be some people that move from one area or another, and in fact there's a lot of opportunity for some synergy, because there are lessons to be learned from how we do review and regulation in other parts of FDA for how we go about approaching tobacco regulation. But there's not going to be brain drain. There's not going to be a mass movement that will shift the agency and lurch us in new directions because of starting up the TB center.
Q: You've mentioned a couple of times now that you'd like to better establish what FDA's global footprint will be. Do you expect to expand the number of FDA's offices overseas?
Hamburg: I think that clearly having overseas offices and potentially expanding beyond the initial commitment is an important part, but I think that's only one element of what has to be a much more comprehensive and strategic approach. Those offices can serve as a hub, can enable us to have a more on-the-ground understanding of what's going on and a nimbleness in a crisis that can be very important. But we really need to build partnerships with other nations and sister regulatory agencies to help us expand our reach in terms of this broad array of facilities both on the food and the medical products side.
And we need to really work on harmonization of approaches, and where there are countries with less developed regulatory frameworks provide assistance and capacity building to help raise their framework for regulations up to the model that comports with how we approach it and how the European Union and others approach it so that we can really share responsibility for safety both on the food and the medical products side.
I met with Dr. Margaret Chan of the World Health Organization, and we talked about the importance of this work and our eagerness to work together. And there are a number of other very important global health issues of concern. H1N1 is obviously one that is very much on our minds, but also issues where global partnership is key, such as counterfeit drugs, antimicrobial resistance, and a number of other areas of concern, including, in fact, tobacco, which we were just talking about before.
Partnering with Industry, Government
Q: Could you expand on your plans to partner with industry? How do you walk the political line while still trying to partner with industry?
Hamburg: I think it would be foolhardy to be too prescriptive right now as I'm just getting my feet on the ground and haven't yet had an opportunity to sit down with various components of industry—I'm just beginning to on the food side and on the pharmaceutical side. But I see industry as an absolutely key partner, critical stakeholder, in what we do. And I think that, like everything, it's a balance. But I'm very eager to learn more about some of the concerns of industry in terms of their work with the FDA, and I'm eager to talk about some of my interests, as well.
I do believe, for example, that this is a good time to really take a look at the Critical Path Initiative, which was put forward a few years ago and I think represents a very important vision about how working in partnership with both industry and academe to really examine how can we leverage existing and emerging science and technology to improve how the FDA does its product reviews.
How we can use advances in genomics and understandings of biomarkers and other expanding insights to improve our review process? And how can we use advances in IT and pharmacoepidemiology to strengthen how we do postmarketing surveillance? How can we work together to improve even some of the most fundamental aspects of communication about understanding appropriate use and the most effective ways to enhance safety of medical products once they're approved?
So I think that there are a number of ways that the conversation with industry will enhance how FDA does business, will enhance the ability of innovators to move products through the system, and ultimately will enhance the health of the American people.
Q: You also mentioned about collaborating, or doing more with your sister agencies. Is there partnering with CMS that you are looking at, so far as helping speed up not just approval but also reimbursement?
Hamburg: I think that FDA can and should do more in terms of working with CMS. There is an opportunity to begin discussions much earlier on about new products moving out of the review process and into the marketplace and helping CMS understand what those products are, and that will, I think, potentially streamline their own procedures for review and reimbursement.
We talked about this just a little bit in The New England Journal of Medicine article that Dr. Sharfstein and I wrote that went up on the website my first official day as commissioner. But we mentioned that as an important aspect of collaboration within the Department of Health and Human Services.
Q: There have been a lot of questions about what FDA's policy is in regard to the Internet and other sort of new promotional venues. Is it your sense that the policy is fulfilling its public health role adequately? Does it need to be refined or just cut back, or should it be expanded? How do you approach promotion and public health for medical products?
Hamburg: I, as a public health professional, care deeply about making sure that consumers get access to appropriate and adequate information about the choices they need to make and that medical providers also get accurate and appropriate information about the medical products that they will be prescribing or recommending for their patients. So I think that that sort of public health principle certainly influences all of my thinking about these issues.
I do worry that in this very complicated media world that we find ourselves in, with blogs and the Internet and 24-hour cable TV and a huge array of other media outlets, that it's very easy for confusing and inaccurate information to get out there, and that worries me.
Obviously, FDA has a more limited role in that, but we have a real responsibility to make sure that where we have authority and opportunity that we provide the clearest and most accessible public health messages possible.
And I would like to work more with drug companies in their advertising to make sure that in addition to whatever message goes out about a particular product that there also is some broader and useful information to the consumer about the medical condition for which that product might be used, and, of course, that any information that goes out as part of advertising is accurate and reliable and reflects the available scientific data.
FDA’s Chief Messaging Tool
Q: What do you view as the FDA's now chief messaging tool going forward, to start turning around the agency’s negative public image? Is it the approval of a drug? Is it the rejection of a drug? Is it withdrawal of a product from the market? Is it your enforcement abilities?
Hamburg: I think leadership is important, and part of why I decided to take on this challenge was that I thought that I could bring some meaningful leadership to an agency that was demoralized and was being buffeted about in the press and had lost some of the trust and confidence of the American people.
When I was New York City's Health Commissioner I came into an agency that was demoralized and cash strapped, and it had once represented the premier health department in the country, and I do feel that through my leadership and a number of important public health activities that we took on and succeeded at that we were able to turn around that image and restore the New York City Department of Health to its rightful place as a leader among public health agencies in this country and the world.
And FDA, similarly, has been the gold standard for a science-based regulatory agency, and it's been important to the people of this country, and it's been important to people around the world. And I think that we need to restore that image. Part of it is, I think, by really making it clear that our mission is to promote and protect the health of the people, and we will pursue that aggressively, using the best available science. We will do it in a way that's as transparent as possible with as much integrity as possible, but across a number of domains of activity that are essential to the health and wellbeing of the public.
We represent a unique and essential agency, and that—we have a really sacred responsibility to fulfill the trust and confidence that the American people need to place in us.
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