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Lester M. Crawford, D.V.M., Ph.D. - National Press Club

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

Speech before
Newsmaker Luncheon
National Press Club
Washington, DC

Remarks by

Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner of the FDA

August 2, 2004

First, let me thank the National Press Club for inviting me here to speak today. These historic rooms have been the scene of many important announcements. Today's announcements will affect the health and well-being of much of the American population.

The Food and Drug Administration (FDA) regulates approximately 25% of the gross national product of the United States. These categories of products – biologics, drugs, foods, medical devices and veterinary medicines – are integral to public health as well as the fundamental economy upon which this great nation is based.

The FDA of today accepts the responsibility of ensuring the suitability of these products but we now likewise accept the responsibility of seeking solutions to the critical public health challenges of today. For example, we know that in the interest of absolute safety, FDA can become an impediment to the development of products essential to medical progress. We likewise understand that in order for FDA to effectively interact with the publics we serve, we must continuously improve our personnel and procedures.

During this Administration, FDA has effectuated some of its most impressive regulatory accomplishments in the nearly 100 year history of the Agency. We have enhanced consumer protection through comprehensive food safety activities and through landmark regulation of harmful dietary supplements. We have materially improved access to safe and affordable medicines through our generic drug program and innovation initiative by improving the efficiency of internal product reviews at FDA. Novel safety standards, innovative technologies and improved surveillance systems have begun to insulate patients from preventable errors. And we have empowered consumers to improve their own health through better information about the foods they eat and the medicines they consume. Understanding the role FDA must play in ensuring that better information must flow to consumers so that they can be a vital part of preventing diseases and improving their basic health profiles has propelled the Agency to the forefront of modern medicine.

The work of the past 3.5 years has produced a set of extremely useful legislative developments, more than at any time in our history. This could not have been done without the cooperation and leadership of Congress and the White House. The Bioterrorism Preparedness Act gave us an algorithm for dealing with the clear and present danger posed to this nation by terrorism. Project Bioshield will enable FDA to stimulate development of safe and effective products designed to ameliorate the effects of terrorism and conventional warfare. The reauthorization of the Prescription Drug User Fee Act in an improved form coupled with the passage of the Medical Device User Fee Act and the Animal Drug User Fee Act have brought well-defined goals and increased resources to 3 key areas. The more recent enactment of the Food Allergen and Minor Use, Minor Species Acts have provided FDA with the wherewithal to bring long awaited improvements to 2 vital Agency responsibilities. No less important was the passage of the Best Pharmaceuticals for Children Act which has provided authority for the Agency to mandate that drugs intended to be given to children should be tested specifically for use in children as well as providing incentives for companies to do this testing on a voluntary basis. The generic drug reforms made possible by the Medicare Modernization Act created new provisions to stimulate generic competition and curb abusive practices which had been aimed at extending patent life.

The purpose of this event is to lay out the DHHS/FDA agenda for the next 6 months. FDA's mission of protecting and advancing the public health requires constant vigilance and continuing effort. There are a number of initiatives that must be finalized and events of the past 3.5 years have dictated some new public health imperatives that must be addressed.

Technology Development and Innovation
Like much of the architecture of health care in America, health information technology has greatly benefited from the leadership of Secretary Tommy Thompson. Thanks to his and the President's leadership, all of DHHS are in close collaboration as we move forward to the realization of the e-healthcare vision.

Personalized medicine, prevention of medical errors, electronic surveillance of counterfeit drugs represent a few of the facets of this revolution in care that will involve FDA. Secretary Thompson recently named me to chair a special department-wide taskforce on medical technology innovation. The idea behind this taskforce is to look for opportunities across DHHS to streamline and promote speedier access to new innovative medical technologies that can improve people's health and save lives. This effort dovetails nicely with FDA's “Innovation Initiative.” That Initiative has met some important milestones: a root cause analysis of multiple cycle reviews; a pilot program to test earlier communication with product manufacturers; a cementing of our partnership with the National Cancer Institute; the establishment of an Oncology Office within FDA to foster innovation in the treatment of cancer.

Over the next 6 months, we will be launching the Agency's framework for “quality systems.” This is a series of recommendations regarding best management practices for FDA's drug review process which will help us place much needed treatments in the hands of patients faster.

Whereas the “Innovation Initiative” looks inward, FDA's “Critical Path Initiative” gazes outward and attempts to address some of the larger challenges confronting the biomedical community. The essence of Critical Path is that the process of medical product development has become costlier, lengthier and more uncertain than ever before. There's a growing chasm between bench and bedside, and it is threatening the very promise of biomedical innovation as the research and development community begins to focus on a group of incurable diseases such as Alzheimer's, multiple sclerosis, lupus and cystic fibrosis.

In response to this serious problem, FDA is developing a versatile applied science toolkit containing powerful scientific and technical methods such as animal and computer based predictive models, biomarkers for safety and effectiveness and new clinical evaluation techniques. The goal is to help predict eventual product failures early during clinical trials and to reduce developmental uncertainties in 3 critical product areas: product safety, medical utility and manufacturing potential. Critical Path will, we are convinced, improve predictability and efficiency and get much needed treatments to patients faster.

In late Fall, FDA will announce the National Critical Path Opportunities List which will pinpoint those areas of product development that could benefit most from innovative approaches and emerging technologies. This will enable us to rally our partners in government, industry and academia to build the path to innovation in these key areas.

Later this year, FDA intends to issue guidance regarding new requirements for screening and proof of concept Investigational New Drug studies. This will help facilitate the identification of the most promising drug candidates to develop.

Modernizing the Health Care System through GMPs
Cutting-edge applied science and a cross-cutting approach are essential to fostering a more modern health care system. Equally important to modernizing this system is the introduction of best practices in product manufacturing.

Good manufacturing practices are not only vital to business success; they are also essential to FDA and they are essential to the public health. It is impossible to inspect every prescription drug pill, every diagnostic testing kit, every animal vaccine, and every food parcel that is manufactured or processed. However, by ensuring the best possible manufacturing practices through tested quality improvement modalities, the Agency can assure products of high quality. Simply put, the use of modernized Good Manufacturing Practices will help eliminate both production inefficiencies and undue risks for consumers.

And yet, in spite of these clear benefits, GMPs in the medical product arena have not incorporated modern quality thinking. And in the case of the food industry they have not been refreshed in nearly two decades.

FDA is turning this around.

We are outlining the latest, scientific practices in manufacturing across the health care spectrum – from pharmaceutical plant operations to food processing to dietary supplement manufacturing.

This month will mark the 2 nd anniversary of our Drug GMP initiative. We have been hard at work these past 2 years overhauling and upgrading the pharmaceutical GMPs, and I am pleased to report that this project will be completed by this Fall.

On the food side, we have a longer road ahead of us. Since the last revision of food GMPs in 1986, we have greatly expanded our understanding of food-borne illness and there have been rapid advances in food processing techniques. To formulate the most effective response to these changes, FDA's Food GMP Modernization Working Group has been undertaking an important series of public meetings this Summer to obtain stakeholder input on ways in which the food GMPs should be updated. With these meetings well underway, we are setting an aggressive timeline to proceed with rulemaking. Later this Fall, the Agency intends to synthesize the data and information received from these public meetings to issue a much-awaited draft guidance to industry.

In concert with the modernization of food GMPs, FDA is also finalizing the first-ever GMP guidelines for dietary supplement manufacturers. A completed set of dietary supplement GMPs will help protect consumers from dietary supplements that contain impurities or contaminants as a result of how they are manufactured or handled.

FDA has, over the past three years, aggressively pursued violations of the Dietary Supplement and Health Education Act, but GMPs in this area will enable us to systematize enforcement and set standards in the rapidly growing supplements industry.

Patient and Consumer Protection
Let us now turn to the subject of patient and consumer protection. As I mentioned earlier, the turn of the century has brought unprecedented new challenges to patient and consumer safety, and we are aggressively moving ahead on a number of important protections and regulations, old and new.

First, I'd like to mention the success of our Generic Drug program in making lower-cost, high-quality medications available to all Americans in need. With the Secretary's leadership and direction, FDA has made this program a top priority and we will continue to do so in the months ahead. In fact, we are approving one new generic every day.

Next, we're moving ahead on a proposed rule regarding the treatment use of investigational drugs. Specifically, this rule proposes expanding access for patients facing terminal conditions to drugs that are still in the investigational (IND) process. This is an important step forward for the Agency, and one that will provide greater access to potential treatments for patients who are suffering the most.

In addition, we're expediting global access to treatments for HIV/AIDS. As Secretary Thompson announced a few months back, we have created an expedited review process to ensure that the United States is providing safe, effective drugs to developing countries under the President's $15 billion Emergency Plan for AIDS Relief. It is our firm belief that these steps will make a huge difference in the lives of millions of people in Africa, Asia, and the Caribbean, who are suffering from this terrible illness by assuring that the drugs they get under this program indeed will be quality products that will offer the treatment they seek. I am delighted to report that two fixed dose combination products have just been approved. These will enable a one pill per day regimen which will have special utility for patients in remote areas.

In addition to these therapeutic access initiatives, the Agency is also moving aggressively to finalize our proposed changes to prescription drug labeling to facilitate the safe and effective use of these products. The idea is to make the label less dense, less cluttered, and more user-friendly, by reordering certain sections, setting minimum graphical requirements, and including both “highlights” of prescribing information and a table of contents. These revisions will make it easier for health care practitioners to access, read, and use information in prescription drug labeling. The revisions will also help reduce the number of adverse reactions resulting from medication errors due to misunderstood or wrongly applied directions and will be a great assist toward the day electronic labeling will be fully accomplished.

Food Safety
In terms of food safety, FDA-CFSAN will be announcing very soon the Pregnant Woman Education Drive. This initiative will target the entire health care community. This program will educate all about what pregnant women should be eating and what they should be avoiding. Cogent, current information about the bacterium Listeria, the parasite Toxoplasma and contaminants such as mercury will be featured.

Importantly, FDA is continuing to bolster safeguards against BSE. This past month, we announced some new regulations from our Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine to better address concerns regarding human food and animal food. In the coming months, we will work to finalize our rules on human food, complete regulations on medical products, and consider additional safeguards for animal feed, particularly imposing a ban on the use of specified risk material in all animal feed. Such new steps will complement the existing BSE firewalls the U.S. government has put in place, and will provide an added assurance of safety for our food supply and other products we all use that are manufactured with bovine derived materials.

We will also be completing in the next few months a landmark regulation to stop the spread of Salmonella enteritidis through shell eggs. The disease caused by this organism kills 87 people and makes 213,000 seriously ill each year. This proposed rule will set up all new risk management procedures to dramatically reduce the risk of transmission of this disease through shell eggs, and in turn prevent thousands of cases of these illnesses.

Empowering Consumers
I would also like to touch on 2 of our priorities to empower consumers through better health information.

You are all aware by now of our efforts to battle obesity. Earlier this year, Secretary Thompson announced a comprehensive set of steps on how to combat this growing epidemic. These were based on FDA's Obesity Working Group recommendations. We have already begun acting on these proposals – we are reviewing ways to enhance the food label; we are kicking off new consumer education campaigns; we are talking with the restaurant industry about how they can provide better nutritional information to their patrons; and we are increasing our research focus on therapeutic treatments for obesity. FDA recently signed a contract with the Keystone Center to convene and facilitate a national dialogue on obesity. Through this dialogue, FDA will finalize the restaurant and consumer education recommendations from the Calories Count Report. Later this Fall, we are going to take another important step forward by helping to demystify carbohydrates. Consumers are confused when they see the terms “low carb” and “net carb”, so FDA will be publishing a proposed rule and providing guidance regarding claims on the carbohydrate content of foods.

FDA also intends to move forward on the recommendation to give prominence to calories and serving size on the food label including proposing to increase the font size and provide a daily value percentage for calories.

We will also be forging ahead in assuring that medical product advertising and other promotion is properly regulated. Today I am announcing the establishment of a new inter-center coordinating group to facilitate the development and implementation of appropriate policies and procedures relating to the promotion of medical products within FDA's jurisdiction. This issue is a top priority for the Agency because of the important role that high-quality information plays in ensuring that medical products are used safely and effectively. This new group will help to rationalize FDA policy and procedures, coordinate enforcement efforts, and establish a unitary means of communicating with the public concerning medical product promotion-related policy issues.

We recognize that there are a number of issues in promotion that have been of concern – for example, the status of outdoor advertising, comparative claims, and implied claims. In the months ahead, look to FDA to provide clarity through guidance on these and other related areas.

Conclusion
I cannot close without thanking Secretary Thompson for his inspired leadership and gratefully acknowledging the manifold contributions of Mark McClellan during his time at FDA.

A physiologist of the 19 th century described the brain as a “fantastic weaving shuttle”, a term of amazement. One could describe the FDA of today as just that. As the work of the Centers and other field force come together to provide a protective tapestry for the American people, we fully realize that tomorrow will present new hazards that we will need to urgently address. And we know that this can only be accomplished through the sedulous application of science, reason and diligence. Ours is no small task and we did not become known throughout the world for what we do except by rising to each occasion and knowing the real and relative risks of each problem before us.

I am thinking now about all we have learned about bioterrorism and how much effort we have expended in that area and how much safer this country is as a result of those efforts. Late last week FDA issued an advisory about two particularly troubling counterfeit drugs that are being smuggled across the border. FDA must thoroughly prepare for products that are legally in commerce and for those that are not. The prospect of any and all of the products we regulate being a vehicle for terrorism is a constant concern. FDA's good relationships with the Department of Homeland Security and other relevant Agencies is rapidly providing a bulwark against these threats.

This is the 4 th time I have been at FDA and the 2 nd time I have been at the helm, all over a 30 year period. I have been proud of all those stints but I do believe the present FDA thoroughly understands its mission to protect as well as prevent and I am more than confident that we are equal to the public health imperatives of this day and this time.

Thank you very much.