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Mark B McClellan, M.D., Ph.D. - Speech before FDLI

This text contains Dr. McClellan's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Speech before FDLI
Remarks by
Mark B McClellan, M.D., Ph.D.
Commissioner, Food and Drug Administration

Tuesday, April 1, 2003
First of all, my Chief Council Dan Troy and I wish to welcome our distinguished guest from Capitol Hill. Congressman Waxman, it’s a privilege to be here today with you, and on behalf of the agency I’d like to thank you for your strong commitment to many of the difficult issues facing the agency. I also want to recognize Jerry Halperin and Mike Hacker for their long-time leadership and support of FDA’s mission. Thank you all for having me here today.


It’s often been said in FDA circles that the speaking slot I’m filling today is the ”State of the FDA” address.

It is a rewarding and exciting time to be at the agency for two reasons that bear directly on the state of the FDA. First, the challenges we face in promoting and protecting the public health are greater than ever. Second, thanks to the professional dedication, creativity, and expertise of our professional staff – combined with legislation that has given us new authorities and resources for carrying out these missions – our ability to meet these challenges has never been greater.

These new challenges and opportunities underscore how important your organization is to our mission at this critical time. Yours is the premier forum for discussing and debating the FDA’s mission and for providing valuable opportunities to bridge FDA to the communities we work with, and especially to help bring in new ideas. And I’m sure everyone at FDA joins me when I say that we appreciate the important role you play. This is especially important as we work together to help FDA rise to our new challenges in the 21st Century.

The volume and complexity of activities for which the agency is charged with regulating has been increasing, and is likely to continue to do so. There are more drugs and medical devices available to save and improve lives, and even more to come. There are more and more diverse food products than ever before – giving consumers more food options to meet their needs more productively than ever. And we are adding to these choices by importing a larger volume and greater diversity of foods than ever before. There are also broader choices in cosmetics. As a result, Americans have more opportunities to improve and enjoy their lives.

These are generally good things for all Americans. But at the same time, they present unprecedented challenges in meeting our regulatory responsibilities. Even as the complexity of these products increases, we must continue our commitment to making sure safe and effective new food and drug products reach consumers in a timely fashion. We’ve been given some authorities for limited regulation over dietary supplements, which are increasing in popularity. Direct to consumer advertising is way up. We have responsibilities over 20% of the consumer economy – an amount that’s growing every year. All of this has immensely complicated FDA’s mission.

There are two serious areas of heightened concern that weigh on our daily work especially heavily.

First, we must respond to heightened threats of terrorism at home, and critical new support roles for our troops abroad. I am sure that your thoughts and prayers, like mine, are with our military personnel who are today in harm’s way. Their service is protecting us here at home, and FDA is doing all we can to support them and to support their mission of protecting America from terrorist states and terrorist groups.

Second, FDA and all of us involved in public policy must do more to control health care costs without sacrificing the great potential of medical innovation in the 21st century. With unprecedented medical treatments worth literally many trillions of dollars in better health have also come concerns about rising medical spending, and in particular rising spending on prescription drugs. This includes concerns about rising drug prices – “list” prices for drugs have been rising faster than inflation, though most people with health insurance get significant price discounts. This is especially true for many seniors, who often have the greatest medical needs but limited incomes, who often lack modern prescription drug coverage, and who too often pay the highest drug prices of anyone in the world. And there is no question in my mind that these cost pressures are going to increase, as more treatment options continue to become available in the years ahead and as our population continues to age.

For the sake of the public health, FDA must find fundamentally better ways to address both of these new threats. With the tremendous and growing volume and complexity of our responsibilities, matched against our limited resources, we must prioritize. We can't do everything. And so, we must think critically and carefully about how we can do the most good for the public health with those resources.

In some cases, this is requiring a reexamination and an updating of the way FDA does its job. We are not here just to check boxes on an inspection list just because that's the way we've been doing it for the past 20 years. We are here to implement the best possible approaches to reduce risks to the public health, using the budget and the authority that Congress has given us. This requires expert knowledge, creative thinking, and dedicated effort, day in and day out.

To bring all this together – our new challenges, our new opportunities, and the most creative thinking from inside and around the agency to prioritize and address them – we have undertaken a major strategic action plan within the agency. This planning started with a retreat involving all of our center directors and senior staff around the time I took office, and has continued at a steady pace to move from defining performance goals, to laying out the strategic objectives required to meet them, to transforming these objectives into specific action plans and performance measures.

That process identified five top priorities for the agency, including three specific areas of major new initiatives and two general approaches that we are reinforcing in order to achieve all of our mission objectives. Right after taking office, I committed to new agency action in all of these areas And thanks to our agency’s experts working together on these priorities, we’ve been able to accomplish much, and much lies ahead. Today, I’d like to give you an update on our progress, and highlight some of the challenges and next steps ahead.

I’d like to begin with the two parts of our strategic efforts that help us accomplish all of our activities as effectively as possible.


One aspect of FDA's work has remained, and will remain, unchanged: the critical importance of the FDA's professional workforce for the success of the agency and for its ability to maintain the high level of public trust in its activities. FDA’s most proprietary and valuable resource comes through the door each morning. There are almost 1,500 people with PhDs at FDA and well over 400 with medical degrees – and that’s without double-counting. The money we’re appropriated each year doesn’t pass through our hands in the form of grants. It gets spent at FDA to carry out our complicated mission. Two-thirds of our budget is spent on our highly-skilled workforce. Our contributions are primarily a reflection of our professional services.

A clear sense of our critical mission at FDA is important for FDA’s professional success -- but a clear sense of mission is not enough to attract and keep the best and brightest, highly motivated employees who are essential to meeting the challenges that the FDA faces in the 21st century. An organization that can keep up with the rapid changes in the industries that it regulates, and that is capable of developing and implementing effective and innovative public health measures, requires a very special workforce. So our mission depends more than ever on a solid cadre of experienced physicians, toxicologists, chemists, statisticians, mathematicians and other highly qualified and dedicated professionals. Their expertise is essential for making our regulatory decisions balanced and fair, and for keeping us on the cutting edge of the technology and sciences used by industry.

Consequently, as FDA Commissioner, it is one of my foremost goals to make sure that the FDA's working environment encourages creativity, efficiency, and superior performance - an environment which attracts and retains top-quality scientists, and enables them to do top-quality work as part of an effective team.

To attract and keep high-caliber employees who are responsive to the changing needs of the agency, we need to be responsive to their diverse needs. FDA is leading the way with many such workforce initiatives already. Our employees can take advantage of flexible work schedules, including an "any-80" program that can fit the difficult schedules of two working parents, sick kids and sick parents, and other outside commitments. About one-fifth of our employees take advantage of our flexi-placing program, which permits telecommuting. And we support employees with child care, elder care, and other distinctive needs.

In a recent survey conducted by OPM to gauge how federal employees feel about their jobs, FDA did very well compared to other government agencies and the private sector, especially in how our employees feel that their individual work here relates to Agency’s core mission. About 73% said that they found FDA a friendly place to work, 82% said their supervisor supports their need to balance work and family issues, and 65% said they would recommend the FDA as a place to work. We’re doing well. We want to do better.

We must reward employees who distinguish themselves and who remain committed to our agency despite attractive outside job offers. On the one hand, I'm glad that so many of our employees have other good options. That tells me that we are attracting very talented people. On the other hand, I don't want to lose them. We therefore offer a range of programs to help recruit and retain talented staff, including expansions of retention bonuses for employees in fields with a particularly high turnover. In collaboration with the National Treasury Employees Union, we are also working to provide additional financial rewards for high performing workers.

But FDA must encourage fresh perspectives and plan for transitions as well. For some of our workers, spending time here as well as in academics or industry is the most rewarding career path, because it is the best way to keep up with rapid scientific change. And more than 30 percent of our workforce will be eligible for retirement in less than five years. So we are working to develop succession plans and career development plans. And we are expanding career options, such as new fellowships and part-time appointments at our devices center, to support combining work at FDA with work in an academic job.

We will continue to find better ways to support our work environment. My first official act as FDA commissioner was the groundbreaking of our new drug center building at the new FDA campus at White Oak, a building that will house 1,700 FDA staff in 2005. There are four additional projects moving forward simultaneously at the White Oak campus, which together will house 7,000 FDA employees in modern office and lab space. And I’m pleased to say that the first employees will be arriving at White Oak this fall. We have a commitment from GSA Administrator Steven Perry to make FDA’s new campus the number one non-security-related priority for the 2005 fiscal budget. We are exploring every possible avenue to expedite completion of White Oak, including innovative public-private partnerships.

The enormity of our job also compels us to seek other new ways to augment our available resources. Jerry Halperin has alluded to one such opportunity: using the technical and scientific expertise and the accumulated experience of FDA alumni. I’m very pleased that people like John Villforth, Burton Love and scores of alumni from around the country have come together to establish the FDA Alumni Association. The FDAAA can offer much to help us meet our new challenges.


A second central theme in our strategic planning is efficient risk management. That’s a mouthful, but it’s a familiar one to FDA experts. Risk management is one of the many areas of regulatory science where FDA has long led the way, in assessing risks to public health and finding the best science for managing them. This is more important than ever, given the expanding complexity of our challenges and the need to reduce the health risks facing the public at the lowest possible cost to society. The principal objective of our strategic action plan is to do as much as possible to improve the health outcomes of the American public.

A lot of people ask me how my background in economics is relevant to this task. Is FDA going to start doing cost-benefit analysis of the products we regulate? The answer is no. That’s not our statutory mandate. Our mandate is to make sure new medical products are safe and effective, and to assure the safety of the food supply. But health care purchasers are increasingly demanding high value in the treatments they pay for, and consumers want a diversity of safe food choices available at the lowest possible costs. So anything we can do in our activities to reduce the cost of developing and using the products we regulate will help. Only by becoming consistently more productive at what we do – always working to get the most public health bang for our regulatory buck - only this way can we have any chance of fulfilling our increasingly complex public health mission. And for this reason, we’re strengthening our economics team and improving our ability to apply cost-benefit analysis in our regulations and our regulatory processes.

I want to illustrate what I mean by “efficient risk management” to fulfill our mission while lowering costs through our work on new pharmaceuticals and other medical technologies.

As many of you know, the approval of new drugs and biologics is now at the lowest level since the Prescription Drug User Fee Act was implemented over a decade ago. The process of bringing a truly new drug to the public is getting steadily more expensive, now costing more than $800 million according to Tufts University studies – more than twice what it cost just a decade ago. Nor has the process become any more certain. Only a small fraction of drugs that undergo the initial stages of development reach early-stage trials, and only a small fraction of those result in new drug applications to FDA. The percentage of drugs that make it through this process has been largely flat over the last decade, and recently, has actually declined.

These challenges are not confined to drugs, but are common to all medical technologies. Concern about dwindling resources at our medical devices center is contributing to fears that U.S. patients may not be benefiting from medical technology as quickly as those in other countries. Staff levels at CDRH have dropped by 8% since 1995, and the average total review time for a major new device (a PMA) is now almost 14 months.

So, one possibility for the future is that the costs and uncertainty of developing medical technologies keeps rising. It’s easy to see how this could happen: there aren’t many relatively easy receptor targets to exploit for creating new drugs; and developing genomics-based therapies remains very costly. It can take a decade or longer now for a new scientific concept to move from the laboratory to the patient who will benefit from it. The additional complexity of assessing genomic and other information could just add to that. So it’s possible that, depending on the regulatory and policy choices that we make, we may not recover from this downturn in new product approvals.

I don’t think the future needs to be that way, or will be. But the fact that the future of medical care is uncertain highlights the need to find ways to help make sure we realize the great promise of better medical technologies ahead. This task isn’t easy - not for FDA, not for health policymakers, and not for the industries we regulate. But threats to the affordability of health care make this a critical challenge.

This is a critical time for health policy. Policymakers need to find ways to act together on creative but difficult health policy reforms, ones that make health care more affordable while still encouraging innovation. But under intense pressure to control costs, they may instead adopt approaches that seem to hold the promise of reducing costs in the short run, based on the experience of other governments. But because some of these “reforms” designed to provide short-term relief tread on the meaningful rewards for developing valuable intellectual property that has made the United States the world leader in many areas of high technology, such reforms could keep us from realizing the tremendous promise of new innovations. This would lead to higher long-term costs from failures to prevent more illnesses, and failure to achieve continuing improvements in our public health.

Instead, we need to find ways to realize more value in what we do to promote the availability of safe and effective treatments, both today and in the years ahead. And we need to do it now.

Along with new health policy initiatives in Congress, we need a lower-cost process for regulating new medical technologies – less costly, more rapid, and more predictable ways of determining that new drugs and other treatments meet FDA’s high standards of safety and effectiveness. Our approach of efficient risk management has implications for every aspect of the process of medical technology development and use. The resources given to us by the prescription drug user fee reauthorization will help. User fees on devices should yield about $225 million in much-needed increased resources over the next five years. And I’m hopeful that the strong bipartisan support for new animal drug user fees will translate into Congressional action very soon. As a result, FDA has unique opportunities at a critical time to improve our regulatory approaches.

Earlier this year, as part of our response to this challenge – to make sure we have regulatory processes that are as efficient and up-to-date as possible – FDA announced a major new medical technology development initiative with three main elements.

First, we are conducting a “root cause analysis” of recent “multiple cycle” product approvals – products that required two or more “rounds” of review before they could be approved. An extra round means at least an extra 10 months or more, which can add many millions to the cost of new products. It also delays availability to patients who might benefit. Often, multiple cycles do not appear to be FDA’s fault. But in our preliminary analysis, it appears that in some cases, early communication and more transparency in our regulatory requirements might help avoid multiple cycles. To that end, we are in the process of implementing two PDUFA pilot programs to evaluate the impact of extensive early communication and of reviewing pieces of an application for potential problems as they come in, rather than waiting for a complete application. These review processes require more agency time up front, but they may pay off in terms of avoiding multiple cycles and thus reducing the total cost of product development significantly.

Second, we are developing “quality systems” for our review procedures. The idea is to apply best management practices internally to our review processes, such as using peer review programs for reviewers to exchange ideas and use each others’ experience to learn about best practices – much as academic clinicians do on rounds. And we’ll be developing performance measures designed to make sure were approving safe and effective treatments as efficiently as possible. Applying such quality systems for technically complex enterprises in which every case has many unique features is a complicated task. But I have been impressed by the response to this initiative by many of our professional reviewers. They believe that clearer measures for evaluating the agency’s performance with respect to its mission goals can help them and therefore the agency do a better job.

The third part of our medical innovation initiative is to work to publish new guidance documents. I know, FDA has lots of guidances, but these will be in areas where we think the regulatory pathways could be improved or better defined, and we expect to learn something from outside experts in the open process of developing the guidances. They include new product guidances for obesity, diabetes, and cancer. In these critical areas, we think that new regulatory standards can reduce the time and cost of product development. That, in turn, should lead to more investment in much-needed new products. We’re working to publish similar guidance in critical new areas of product development, where clear regulatory pathways are not yet well defined – including pharmacogenomics, novel drug delivery systems, and cell and gene therapy.

For example, the guidances may consider the use of bio-imaging tools may help us to more quickly, and accurately, map drug distribution into difficult to reach areas like across the blood-brain barrier and into bone. And the use of validated biomarkers may be able to streamline clinical trials by shortening follow-up times, and enrollment of patients who are likely to respond based on a molecular signature could reduce the size of the studies, as well as make sure patients are getting a maximal benefit from every pill they buy. The FDA is going to be running joint workshops with groups like the American Society of Clinical Oncologists and the National Cancer Institute to help in the development of these biomarkers. The utility of having objective measures by which to measure drug response has appeal, because we know our existing methods are sometimes not exact. For other technologies, such as cell and gene based therapies, we intend to establish educational partnerships, including some with NIH, to help sponsors craft research programs that can lead to approval.

Another application of our principle of efficient risk management to reduce medical costs is overhaul of pharmaceutical good manufacturing practices. GMP policies haven’t been updated in 25 years. Meanwhile, best practices in manufacturing technologies and methods have undergone significant progress over that time. This broad-based program is developing new GMPs based on the latest science of risk management and quality assurance. The new standards are being designed to encourage innovation in manufacturing and technology; coordinate submission review and inspection programs; and ensure their consistent application by all three FDA centers that regulate pharmaceutical products. This includes new guidance from CBER on the manufacturing requirements for novel technologies such as cell processing and gene therapy operations. Last month, we provided a detailed update on this major effort, including the announcement of some preliminary reform steps, such as adjustments in part 11 regulations and inspection processes. Next week, we are holding a major conference with our Science Board to lay out and discuss key ideas that may be implemented in our final regulations. The medical device user fee act also significantly expands FDA’s informal policy of allowing third parties to conduct facility inspections under more closely supervised conditions, to give some manufacturers the flexibility to have their inspections carried out more quickly without sacrificing stringent safety standards.

Our approach to risk management also includes finding ways to help make sure that drugs we review are used safely once they’re approved. Too often, the drugs, devices, and other products we regulate are involved in preventable adverse events. As many as 20% of Americans have experienced some kind of medical error. Preventable errors and complications involving prescription drugs alone are responsible for thousands of deaths, millions of hospitalizations, and billions of dollars in additional health care costs each year, not to mention all of the unnecessary suffering. That money would be better spent on care that actually made people healthier – care that added value. At FDA, we think preventing adverse events and improving our post market activities is so important in reducing costs and improving value in health care that it’s one of the five key elements of our strategic plan.

Adverse events that I consider preventable aren’t just caused by human error. Even with the best available data, drugs are sometimes found to have adverse effects that couldn’t have been predicted or uncovered in any feasible clinical trial. Most of these subtle or rare problems such as liver toxicities or adverse interactions in certain patient groups occur with new products, and usually become apparent only after the product has been on the market in use with real-world patients for some period of time. It’s during this time that we have to be especially vigilant; if we don’t have effective systems in place to detect such problems, then preventable adverse events are occurring that should not, and that needs to be addressed.

So we are working on developing information technology tools that will allow us to link into the electronic medical records of large healthcare institutions and organizations, and automatically scan medical records for combinations of new drugs and clinical endpoints that might be harbingers of trouble. We recently announced a pilot collaboration with New York’s Columbia Presbyterian that does just this; a similar pilot project involving medical devices will hopefully expand to 200 institutions and to additional product types within the coming year. More collaborations are being negotiated. The idea is to have the capacity to acquire automatically, in real time or close to it, information that might be a red flag. We want to have systems in place that allow us to be proactive in collecting this safety information, rather than relying only on vigilant health professionals to send it to us. And this is a two-way street: our partners in these new activities will benefit fro early feedback from us, and improved, up-to-date electronic drug labels as part of our new DailyMed program.

Often adverse events are caused by metabolic interactions between drugs, dietary supplements and OTC products. In response, FDA and industry have together devised methods of investigating these interactions in “in vitro” models of liver cells that can predict whether or not drugs are going to interact with one another. These models are being used to help us work with sponsors to design trials that will generate the most information about whether drugs are going to interact badly with one another, and as you know, this is a critical question that comes up during every regulatory review.

In addition, FDA can encourage more effective, high-value use of prescription drugs by helping patients and health professionals get better information. For example, package inserts have become so laden with legal considerations that they are often unintelligible to the average consumer and ignored by many physicians. They’ve become liability avoidance tools rather than efficient risk communication tools. They should be written with a patient in mind, not a jury. How many patients and doctors ignore hard-to-read labels? How many of these patients then go on to have an adverse event that could have been avoided if they knew what to watch for?

We are also working on improving our regulation of DTC advertising. Evidence from studies by FDA as well as consumer groups and other entities consistently shows that DTC ads lead to more patients seeking care for undertreated conditions, often resulting a different treatment more appropriate for the patient than the advertised drug. But physicians and others are concerned that consumers may not always get a balanced view of the benefits and risks of a product. Consequently, we are working on new guidance to provide clearer brief summary information drawn from a drug’s label that is written in language consumers can understand and use. We are also making sure that our warning and untitled letters will stand up in court, to provide more effective deterrence to recurrent patterns of misleading advertising.

A final critical area where FDA has stepped up its efforts to improve the availability of low-cost, safe and effective medical care involves generic drugs.

Generic drug manufacturers produce medications that are just as safe and effective as their brand counterparts – in fact, part of the FDA's mission is to make sure that's the case. Yet the prices of generics are much lower: a generic version of a $72 average brand-name prescription costs about $17. And thanks to more brand-name medications coming off patent -- over 200 of them in the next few years -- as well as to the ever-improving scientific knowledge and public awareness about the benefits of generic drugs, the health and economic benefits of using generic drugs are growing. Encouraging rapid and fair access to generic medications after the expiration of appropriate patent protection is, therefore, a key part of providing lower-cost, safe and effective treatment options for patients.

We are doing more to reduce the time it takes to make generic drugs available. First, we are completing review of comments on our new proposed regulation to improve implementation of the Hatch-Waxman law. This regulation, which addresses problems in the use of the automatic 30-month stay and tightens the set of patents that qualify for protection, will be published in final form soon. Second, we are in the process of reforming the way we review generic drug applications. Today, it typically takes 20 months to approve a new generic drug, because generic drug applications generally take more than one review cycle. Only 7 percent of generic applications are approved on the first cycle, and only about a third are approved even by the second cycle. With our proposed expansion of our generic drug office – the $13 million increase proposed for the next fiscal year is the largest increase ever – we intend to do our part to change this. We will not only reduce our review times; we will also provide earlier feedback and guidance on generic applications. In return we will expect generic manufacturers to do their part to get it right the first time in their applications, so that all new generic drugs can be made available in less time and at a lower cost.


A third element of our strategic plan is reducing adverse events involving the products we regulate. I’ve already mentioned a number of the steps that we are taking toward bringing our systems up to date with the emerging capabilities of modern electronic health information systems.

But that’s not all FDA is doing. Last month, FDA made some additional major patient safety announcements. These included a proposed rule to require a universal barcoding system for prescription medications, to support the development of better systems to support health professionals. The proposed barcode rule would apply to all prescription drug products, including biological products and vaccines (except for physician samples), as well as over-the-counter drugs that are commonly used in hospitals. The rule may reduce by half or more the large number of medication errors that occur at the dispensing and administration stage, by helping to make sure that the right patient gets the right drug at the right time.

A second action the FDA recently announced -- the proposed revamping of our manufacturer reporting requirements for adverse events -- aims to enhance the agency's ability to effectively monitor and improve the safe use of medications including drugs and biologics. Among other things, the proposed rule would improve the quality and usefulness of safety reports submitted to the agency, by giving us more detailed information on serious actual and potential adverse events, especially those involving new products where toxicities are not yet thoroughly understood. It also uses standards that we have worked with regulatory agencies around the world to develop, so that manufacturers can submit one accurate and complete report rather than many. It will require the submission of all suspected serious reactions for blood and blood products, not just deaths. These steps would provide FDA with more useful, timely, and extensive information to support quicker, more effective actions by the agency to prevent adverse events.

FDA is also working to reduce adverse events associated with dietary supplements. On the basis of new evidence in the medical literature and in adverse event reports that there are reasons for heightened concern that dietary supplements containing ephedra, the FDA and HHS announced a series of steps recently to protect Americans from the potentially serious risks of these dietary supplements. The dietary supplement statute requires us to prove, scientifically and legally, that a supplement presents an unreasonable risk in order for us to take regulatory action. So, we are seeking rapid public comment on the new evidence on health risks associated with ephedra to establish an up-to-date record as quickly as possible, to support restrictions on ephedra-containing products and the need for a strong new warning label on any ephedra products that continue to be marketed. We are also executing a series of actions against ephedra products making unsubstantiated claims, for example about sports performance enhancement, and against manufacturers that in effect are marketing alternatives to street drugs.

To help consumers continue to get unadulterated dietary supplements, we also proposed a major new regulation to require good manufacturing processes in their production, packing, and holding. The proposed rule would, for the first time, establish standards to help ensure that dietary supplements and dietary ingredients are produced without contaminants or impurities.


For all that improving medical technology can do – and it can do a lot – it is much less than people can do through their own choices to improve their health. And so the fourth element of our strategic plan is improving consumer and patient information. From better patient labeling, to clearer guidance for direct to consumer advertising, to new enforcement initiatives against dietary supplement manufacturers who make health claims without scientific foundation, FDA is undertaking new efforts to help consumers make better-informed decisions. I’ve already talked about our interest in improving information about medical products.

The agency is also implementing a science-based process to review health claims by foods and dietary supplements where they are supported by the weight of scientific evidence – a “qualified claim” approach that has long been used by the Federal Trade Commission, and for which there is much evidence that consumer behavior will respond. These efforts include the appointment of a Better Information for Better Health Task Force to develop an appropriate paradigm for qualified health claims for food, and to identify a research agenda for improving our ability to help consumers understand those claims. These claims must be preapproved by the FDA before they can be used, to make sure they accurately reflect the latest scientific evidence on the claim and on how consumers will interpret it. Considerable evidence from the FTC and other independent sources indicates that these steps can inform consumers and change behavior in beneficial ways, by encouraging competition not just on portion size and ease of preparation, but on the health consequences of a consumer product. A new era in which FDA pre-review can improve competition that gets better health information to consumers is needed now more than ever, as the problem of obesity worsens and as millions of Americans suffer from heart disease, cancer, diabetes, and other illnesses that can be prevented by changes in their behavior.

Our Task Force also has a special subcommittee that's considering options for dealing with fraudulent claims on dietary supplements. To create an effective marketplace for health information, FDA must aggressively use its available authorities to ensure that health-related information available to consumers is truthful and not misleading. As consumers are getting more involved than ever in taking steps to promote their own health, I view it as a public health threat if they waste their money and time on ineffective treatments as a result of misleading information that does not reflect the scientific evidence. Consequently, we are strengthening enforcement against dietary supplement manufacturers and others who make health claims – claims about disease as well as structure-function – that are not supported by science.

Our new proposed rule on dietary supplement manufacturing practices will also help make sure that consumers get accurate label information about the actual amount of active ingredients in the dietary supplements they use.

We also need to improve the nutrition label, including appropriate guidance on trans-fat content in foods. And we need to make sure that our policies effectively address science-based concerns about whether any new bioengineered foods create risks of allergenicity, bioactivity, or toxicity. FDA is already doing much in these areas, but we need to do more.

Finally, in support of actions by the State Boards of Pharmacy in Arkansas and Oklahoma, FDA issued Warning Letters to a firm that is illegally importing prescription drugs. The letter notified the firm that the agency considers its operations to be a risk to the public health, and in clear violation of drug safety laws. Like the American Medical Association and the Canadian Medical Association, FDA is particularly concerned about companies like this one making misleading assurances to the public about the safety of their drugs – claiming that they have appropriate regulatory oversight and that they are FDA-approved, which they are not.

Improving product labels and promoting competition among products based on their health consequences are only some of our activities to help consumers make better-informed decisions about their health. We are, right now, developing a new communications strategy designed to reach out both more broadly and specifically to more precise segments of our consumer audience: young people, seniors, parents, Hispanics, African-Americans, student athletes, persons suffering from serious illnesses (to name only a few), as well as to our other “target audiences,” at home and abroad including professional organizations, trade associations, academia, consumer advocates, and think tanks. Our expanded external relations effort will use all of FDA’s assets, across competencies and centers to help advance our five key strategic goals. And we will start by making sure we are listening carefully to the groups affected by our actions.


I’ve saved our biggest new challenge for last: meeting FDA’s urgent responsibilities to make the country more secure is the fifth major component of FDA’s strategic plan.


We all know that, because attacks are possible on civilians here at home as well as on our troops abroad, we have new challenges in protecting our food supply. At our agency, we’ve been making fundamental changes in how we implement our public health mission. We no longer talk about “food safety” – focusing on protecting the food supply from what can go wrong. We must worry about food security – protecting our food supply from deliberate attack. You all know about the potential for agents of bioterrorism such as anthrax and botulinum toxin to be used to contaminate our food supply. You also know about the potential for contamination by chemical agents, as illustrated by past episodes of cyanide poisoning in imported grapes and by terrorist cells in Europe that were caught trying to make the potent poison ricin. Especially at a time of heightened national alert, the security of our food from deliberate attack by terrorists is a real concern. And in meeting these new food security challenges, we are improving the safety of our food supply as well.

Let me briefly recap what the FDA has done to safeguard food in the past year. We completed a threat assessment of different categories of food, determining the most serious risks of intentional contamination during various stages of food production and distribution. The results are classified, but we know that we need to work with state and local governments and with industry to address the challenges to food security. And so we are implementing new procedures to share relevant sensitive information with our partners who need to know.

We have participated with other agencies, most notably the Department of Agriculture, the White House Homeland Security Council, and now the new Department of Homeland Security, in numerous coordinated planning programs as well as internal and external counterterrorism exercises to evaluate the government’s emergency response capabilities in various simulated food borne outbreak scenarios. And we've discussed food security and rapid response and recovery procedures with more than 35 industry groups and trade associations.

We've also drawn on last year’s special appropriation of $151 million to hire more than 800 new employees, 655 of whom are earmarked for food safety activities in the field. And I’m pleased to report that, as a result of an aggressive hiring and training program at the agency, these new employees are on the job now to help make the food supply more secure. Our new employees are greatly increasing our presence in the United States ports of entry, as well as increasing our capacity to monitor both imported and domestic foods for evidence of inconsistencies and tampering that could indicate a security threat. And we are doing more food testing than ever. To support the training of the agency’s new hires as well as the estimated 50,000 state, local and tribal officials who are expected to cooperate in the nation’s enhanced security programs, our agency has developed new and retooled existing training procedures. Thanks to this intensive training, newly hired lab analysts and investigators start to work on their urgent mission just three months after they come on staff.

And we’re doing more. Two weeks ago, we announced a set of new food security measures as part of Operation Liberty Shield. Operation Liberty Shield is a comprehensive, multi-agency national plan designed to increase protections for America's citizens and infrastructure while maintaining the free flow of goods and people across our border with minimal disruption to our economy and way of life. The Department of Health and Human Services has many critical roles in this effort.

As part of Operation LibertyShield, we published common-sense food guidance documents on food security relevant to just about all firms involved in food production, ranging from the smallest mom-and-pop operations and county fairs to the largest food producers. They cover all major sectors of food production, distribution, and use.

Also as part of Operation Liberty Shield, we are increasing our food inspections and sampling for important agents of terrorism. We have recently invested over $1 million in emergency funds to purchase test kits that enable us to sample for these agents, and we are starting to use these kits more widely in our inspections and testing of both domestically produced and imported foods.

We’ll be undertaking further efforts to work with the food industry as we carry out investigations and import audits, and as we implement new procedures, to make sure the measures lead to the greatest benefits for food security without imposing unnecessary costs or regulatory burdens on food production, processing, and distribution. And we want to make sure firms remain aware of potential terrorist activities, especially as they relate to raw material shipments, inventory quarantine procedures, sourcing of foreign products or ingredients, and vulnerable operations.

Finally, we've been busy implementing the Public Health Security and Bioterror Preparedness and Response Act. This law substantially enhances our authority to ensure the security of food, with emphasis on import security, by requiring four major new food security regulations. Proposals for two of the regulations -- registration of facilities, and prior notice of imports -- were published early this year, and are coming to the end of 60-day comment periods. The other proposals, for record keeping and administrative detention, are in review and will be published in the next several months. We are committed to implementing these regulations on time, after taking account of constructive comments gathered from all interested parties, in conjunction with a major domestic and international outreach and education initiative.

Over the coming years, I believe the best solution will be the adoption of a risk-based import surveillance system to replace our current import program, which is fully linked with U.S. Customs entry processes – processes that have historically been designed to address revenue and trade issues, not public health issues. We're moving in the direction of a modern, risk-based system for food imports already. This includes shifting toward a "life cycle" approach. For example, for bulk imports, instead of a taking a snapshot at the border by examining and sampling a particular shipment, we're trying to get a broader picture that covers the product's history from raw materials, through production, transportation, storage, to the U.S. manufacturer/producer if there is one, and to the ultimate consumer. We are also factoring in the risk information in deciding how to manage the risk, whether by working with foreign countries and manufacturers to improve compliance, or by conducting detailed border checks of final products that present significant potential risks, or by facilitating entry of products that provide assurance that they meet our health and safety standards.


We’ve also been engaged in an accelerated, major new focus on helping to develop and make available better countermeasures for biological, chemical, and radiological attacks. I’m pleased to tell you that, in the last two months alone, we’ve taken major steps to make available safe and effective treatments for certain nerve gases and radiologic agents, and enhanced our stockpiles of vaccines and treatments for smallpox and other possible agents of biowarfare. FDA is going to be critically important in bringing these products to fruition.

At the same time, we realize that we can’t easily solve the problem of getting safe enough and effective countermeasures to the public with just grants and contracts, important as those are for promoting basic research. Our close work with the developers of these new products – which now requires the full-time effort of around 200 professional staff in our biologics program alone – has reminded us that “proof of concept” is still a very long way from large-scale production of effective countermeasures that pose acceptable safety risks. To bring badly needed, safer and more effective countermeasures to our nation’s defense, we are going to need to do more to encourage all parties – basic science researchers in government labs as well as major medical companies – to take up the cause of developing countermeasures.

While the countermeasures we’ve made available already have given us a deeper and more effective stockpile of treatments than ever, in many cases they are based on old technology. For example, monoclonal antibodies have changed the way we treat everything from heart disease to cancer, and in scientific circles it’s considered a mastered technology. Many researchers believe this technology can be effectively applied to developing countermeasures for everything from anthrax and botulinum toxins to the Ebola virus. Yet there is only limited research into the application of antibodies to bioterrorism countermeasures, and no product in advanced clinical development. Instead, currently-available antitoxin to botulism is based on a technology available when the FDA came into existence in 1906. This is a useful and needed treatment, but there’s strong reason to believe new technology can produce antidotes and vaccines that are even safer and more effective – and so more valuable – than what’s available to us now.

Research and development into new countermeasures has been slow, largely because there is no financial incentive. Many companies I have talked to know that the development of medical products is an uncertain process, and they are used to taking risks knowing they might fail. But they want to know that if they succeed, there’s the certainty of a reasonable financial reward. When it comes to countermeasures, there are plenty of risks, and few clear rewards. I’d point out here that this situation is what I want to avoid for naturally-occurring diseases. Without significant financial rewards for effective, high-value new treatments, with no surety of payments because reimbursement from the only major purchaser (the government) is based on the pressures of the appropriations process and not the value of the innovation, we end up in a situation where the incentives for developing better treatments are inadequate, and where the potential value of modern medical technology is not fully realized.

This is why the President has proposed Project Bioshield, a set of initiatives that has attracted bipartisan support. It includes new procurement authorities to provide a certainty of payment in advance for the delivery of effective new products. By creating conditions for a market that is reasonably predictable and consistent over time, the government will set the stage for the private sector to make the investments and problem-solving efforts required to develop more effective, next-generation countermeasures. We expected more antidotes and vaccines to flow out of Bioshield, and at FDA we’re ready to help facilitate their development and to make sure the best available treatments can be used effectively in an emergency.


We must all work to make sure 21st Century innovations in medical technology and in food production provide the greatest public health good to the greatest number of people. As Commissioner, I am committed to working with my colleagues at FDA to strengthen our workforce, to improve our agency, and to get our job done. Protecting and improving the public health provides daily opportunities for excellence and creativity in making our country a still better place to live.

I want to thank my fellow FDA workers for their dedication to the mission entrusted to us by our fellow citizens. And I want to thank you all again for all your efforts to make it possible to bring the agency's nearly century-old tradition of promoting the public health into the 21st century. We all need to work together to fulfill this mission under some challenging new circumstances. As we approach FDA’s century mark, it’s important to remember that FDA’s hallmark has been its ability to adapt, its diligent work to keep up with the best new science and the best new opportunities to fulfill its mission. That’s s in the best interest of the public health. And that is why I’m sure you’re enjoying your jobs as much as I’m enjoying mine. We’re in the right place at the right time to make a real difference in the health of all persons, today and in the future. I’m looking forward to continuing to work with all of you on these great challenges.