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Jane E. Henney, M.D. - Purdue University

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

Remarks by:
Jane E. Henney, M.D.
Commissioner of Food and Drugs
U.S. Food and Drug Administration

Purdue University School of Pharmacy and Pharmacal Sciences
Varro Tyler Lecture Series
FDA and Public Health: Putting Science to Work

West Lafayette, IN
October 2, 2000

Good morning. It's a pleasure to be back in the state of Indiana and an even greater honor to be at Purdue today to present the Tyler Lecture.

As students and faculty of Purdue, you may know this, but FDA's connection to Purdue goes back more than 125 years. The first FDA Commissioner, Harvey Washington Wiley, accepted a faculty position in chemistry at Purdue when the university first opened its doors in 1874. Several years later, history tells us, he was passed over for the position of university president--more than once, in fact-- because he was considered to be "too young and jovial," "not orthodox in religion," and "a bachelor to boot." Apparently his riding around campus on a bicycle wearing knee breeches and playing baseball with the students was not looked upon favorably. After his colorful 9-year association with Purdue, Dr. Wiley landed in Washington, D.C., having gained international recognition as a food chemist.

Harvey Wiley was a man with a mission. From 1902 until 1906, he was intent on proving that preservatives and coloring agents in foods were harmful to people. To support his theory he maintained a "poison squad" of human volunteers. This brave crew was fed a strictly controlled diet, to which Dr. Wiley added small amounts of adulterants--like boric acid, which was used as a preservative in those days--to their diets until the volunteers showed symptoms such as headaches, depression...or worse.

The results of Dr. Wiley's studies helped pursuade Congress to act on his proposals to safeguard the public health. Harvey Wiley devoted the rest of his career to food safety and is today considered to be the "father of the Pure Food and Drug Act" of 1906, a law which led eventually to the establishment of the Food and Drug Administration. Fortunately for our staff, we've advanced far beyond the methods Dr. Wiley employed with his poison squad.

Incidentally, Harvey Wiley didn't leave his pioneering transportation methods behind at Purdue. He was the second person in Washington to own a car and the first to be involved in a car accident.

As the FDA commissioner, I am frequently asked...what is the biggest challenge facing the agency? It seems to me that FDA's greatest challenge lies in maintaining scientific strength. The public's trust and confidence in FDA are tightly linked to our ability to make decisions that are independent, objective and grounded in science. This is true when the FDA decides whether to approve a new drug or vaccine, whether to recall a food product, or whether to issue a warning about how a medical device can fail.

Most Americans aren't scientists, but they know intuitively how important science is in making regulatory decisions. They trust FDA to employ scientific principles, methods and data to drive its policy-making as well as the tough decisions on the relative risk and benefits of products under its jurisdiction.

FDA has earned the trust of those it serves. An April survey of federal regulatory agencies, conducted by the Pew Charitable Trust, asked the medical profession, patient advocates, the chronically ill, and those business regulatory officers with whom we interact, their opinions about the FDA and its decision-making.

The survey showed that, first and foremost, these highly varied groups have confidence in the agency. Seventy-two to eighty-five percent of these groups trust FDA to make the right decisions, and seventy-four to eighty-seven believe that FDA uses good science in its decision-making. The message is simple and it came across loud and clear. Trust and confidence are earned by relying on science, not whim.

Assessing the safety and efficacy of these increasingly complex products we regulate requires that--as I said a moment ago--our decisions be objective and based on scientific evidence. Our actions need to meet our very high standards, and be timely and predictable. Finally, and very importantly, our decision-making processes must be open and transparent to the public. It's essential that scientists, health professionals, patients and the regulated industry understand our decision-making processes and have the opportunity to provide comment and feedback.

These are the principles and values that have enabled FDA to earn the trust of those it serves.

Maintaining the public's trust and confidence is essential as we wrestle with issues and decisions that directly impact people's lives and way of life.

Today I'd like to touch on some issues that are now in front of FDA, to emphasize how science is key to making the decisions we make at FDA.

While many people think of FDA as the agency that reviews and approves medical products, this is only part of FDA's mandate. FDA oversees an immense range of products, including food, cosmetics, veterinary drugs and feeds, vaccines, the nation's blood supply, drugs and medical devices from the very simple to the most complex. In fact, twenty-five percent of the U.S. Gross Domestic Product is under the purview of the FDA.

When we do engage in product review FDA's responsibility does not end once a product is approved. FDA is committed to the lifetime of the product-not just from the early stages of product development, and product review and approval, but after they reach the marketplace and are used by health professionals and consumers. We continue monitoring the safety issues of a product as it is used in practice to make sure that the benefits always outweigh the risks.

The types of decisions we make are wide-ranging, and all rely on science-from the approval of drugs, medical devices and biologics, to writing guidance documents for industry, to responding to public health crises. We use science in making policy decisions on issues such as how to regulate genetically engineered foods, or the products that will emanate from the Human Genome Project. We conduct science-based inspections of manufacturers to make sure they're using adequate quality control procedures. And we use science to support a wide range of enforcement actions to prevent unsafe products from reaching consumers. These actions may range from preventing the entry into this country of illegally imported foods or drugs, to conducting product recalls or seizures, to criminal prosecution of illegal activities.

FDA is well supplied with issues and interesting questions. How do we manage this diversity of issues? We do so by first attending to those problems or concerns that pose the greatest risk. At the same time we must use our scientific expertise and be agile enough to meet the unexpected challenges that arise, and they seem to...nearly every day.

Having a scientifically strong cadre of medical officers and scientific professionals ensures that we can fulfill our mission of promoting and protecting the public health. To be strong as an agency we need to continue to attract and retain an enormous wealth of scientific talent at all levels and in all parts of the agency.

We must also train, retrain, and provide continued learning for all of those in the agency who rely on science to ground their decision-making. Our scientists must be up-to-date in their areas of expertise, quick learners in new areas, and willing to adapt to the rapidly changing technologies facing them. FDA's need for scientific expertise extends well beyond the review function. Our scientific team encompasses a surprising diversity of expertise--physicians, pharmacists and toxicologists, veterinarians, chemists, engineers and computer scientists, statisticians and epidemiologists ...all have critical roles to play, both individually and collaboratively. By putting the best scientific information and thinking to work we can make scientifically sound decisions in all the areas I've mentioned, in an informed, efficient and fair manner.

With scientific strength comes the capability to provide guidance to industry in their efforts to develop and market high-quality products as efficiently as possible. Let me give you an example.

We have a well-trained and well-prepared emergency response team that allows FDA to respond quickly to public health crises--for example, to identify and resolve problems involving illnesses caused by food-borne pathogens or contaminants in the food supply. You've probably heard about the illnesses caused by E. coli in juice and sprouts. In addition to our emergency team issuing public health warnings, recalls, and undertaking the necessary epidemidogically driven traceback work - we also engage in looking for way these products can be safer for consumers. At FDA's National Center for Food Safety and Technology, together with our academic partners from the University of Technology Institute and members of the industry, we're defining ways to treat both sprouts and apple juice so these products will be safe for consumers. For sprouts, the FDA has issued guidance recommending seed disinfection (with solutions such as calcium hypochlorite) combined with microbial testing of used irrigation water to determine whether the pathogens Salmonella and E. coli O157:H7 are present. Clearly, pathogens in apple juice can be eliminated by pasteurization, and FDA has initiated educational programs for consumers, and is requiring warning statements on the labels of unpasteurized juice.

Another example of this type of scientific collaboration with the outside scientific community comes from the drug area...the drug interaction between terfenadine, and ketoconazole. You're probably aware of the possibility of drug interactions involving terfenidine, but you may not realize that FDA played a major role in the research to describe these interactions. This work occurred during my first tour of duty at the FDA and involved a collaboration between FDA, clinical pharmacologists at Bethesda Naval Hospital, and researchers at both the Uniformed Services University of Health Sciences and Georgetown University. A patient presented to Bethesda Naval Hospital with dizziness, loss of consciousness, and a form of polymorphic ventricular tachycardia, known as torsades de pointes. This condition is most often drug-induced. This case was the first reported incident of symptomatic polymorphic ventricular tachycardia (other than an overdose) occurring with the use of terfenidine in a patient. This patient was taking the recommended dose of terfenadine in addition to cefaclor, ketoconazole, and medroxyprogesterone. At Bethesda Naval Hospital, astute pharmacologists recognized a potentially serious drug interaction.

FDA grants to Georgetown University made it possible for Georgetown faculty to work with scientists at FDA and the Uniformed Services University to collaborate on studies to document these interactions. Mechanistic studies performed at Georgetown allowed the FDA to predict other drugs capable of causing the same problem. Eventually, terfenadine, astemizole, mebefradil and cisapride were taken off the market because of actions and interactions that were identified.

Another example of the benefit of having a skilled scientific team occurred this past year when concern arose about a biological product that was being used in a human study to treat children for neuroblastoma at St. Jude's Hospital in Memphis. The product, an adenovirus vector engineered to carry the complementary DNA for interleukin-2 and used to introduce interleukin-2 (IL-2) coding sequences into children's autologous neuroblastoma cells, had not been adequately tested for HIV or the Hepatitis C Virus and was highly suspected of being contaminated with these viruses. St. Jude's had initial tests conducted by a contract laboratory using PCR-based assays detected HIV and Hepatitis C Virus viral sequences. Children had already been treated with this material that had tested positive when FDA's Center for Biologics Evaluation and Research (CBER) was notified of the situation. CBER quickly pulled together a team of research scientists with appropriate expertise to tackle the problem, and asked for samples of the product so it could conduct its own tests. They then used a test called RT-PCR (or reverse transcriptase polymerase chain reaction) for detection of HIV and Hepatitis C Virus RNA, and another test, DNA PCR, for detection of HIV. Within 7 days of receiving samples--and there were only scant amounts left-- of the product, the team was able to determine that the product was not, in fact, contaminated with either HIV or the Hepatitis C virus, relieving the anxiety of the patients and their families that had been caused by the initial false positive results.

Science is also critical to standard-setting, an integral part of FDA's mission. Standard-setting is a major focus of activity for FDA's Center for Devices and Radiological Health, or CDRH, which regulates medical devices from wheelchairs to cardiac catheters, and radiological devices from mammography equipment to microwave ovens and cell phones.

An interesting example of the importance of standards occurred a few years ago when infrared night vision goggles were being shipped to the U.S. from the former Soviet Union. The goggles were stopped at the border and FDA was notified because some of the goggles were equipped with lasers for targeting, and the lasers didn't meet laser standards, which FDA sets. Scientists at CDRH happened to recall that the 25-year old technology for night vision goggles produced X-rays, and decided to test these goggles to see whether that was a problem. As it turns out, half of the goggles tested did produce X-rays, which would be reflected back into the eyes of the user. FDA then contacted the manufacturers and worked with them to change the manufacturing process to eliminate the problem.

We are a science agency but we're also a regulatory and law enforcement agency, and good science must support our enforcement actions. Occasionally these may result in removing unsafe and/or illegal products from the marketplace. Gamma hydroxybutyric acid, or GHB, and gamma butyrolactone (GLB), or 1,4 butanediol (BD) were distributed as dietary supplements. The kinds of effects that were seen included slow respiratory rate, unconsciousness, coma, vomiting, seizures, bradycardia and even death. Although FDA banned the use of GHB in 1990, some companies switched ingredients to GBL, and then to BD. These are all similar chemicals that are metabolized to GHB. They were being marketed as dietary supplements for bodybuilding, weight loss and sleep aids, and as "party drugs." They're often advertised in muscle-building magazines and sold at the gym or in health food stores. These products have been used as "date rape" drugs. FDA has emphatically warned consumers and health professionals about the dangers of taking these products masquerading as dietary supplements that are in fact drugs or pro-drugs. Several manufacturers have agreed to voluntarily destroy their products. FDA has issued warning letters to other companies, seized a number of these products, and taken criminal action against those who market and distribute them.

From an international perspective, FDA's scientific strength is imperative as our country pursues aggressive foreign trade policies, sets standards, and settles disputes that will inevitably arise. Science provides the context for public health and safety issues. Our high bar--the gold standard for product review-- can thus have an impact not only for our citizens but improve product review and public health worldwide.

Let me give you some examples of what we are doing in this area. The International Conference on Harmonization, or ICH, is an ongoing 10-year effort involving the U.S., Japan and the European Union that is leading to the standardization of approval requirements among our countries so we can simplify the regulatory process for companies seeking product approval in two or more of these countries at the same time. Through the ICH we're streamlining the drug approval process by standardizing test guidelines, requirements and applications to create a level playing field across our countries' borders, and at the same time, continuing to ensure the safety of regulated products. Companies may soon have the ability to submit one application that can be reviewed around the world.

Let me spend just a few moments discussing the part of the agency that is often the most visible but is also highly dependent on our having first rate scientific talents to apply to the task.

Before 1992 - the agency had far too few reviewers to manage the ever increasing number of applications that were coming in from industry. The result was a back log--and ever increasing review times. A situation frustrating for an agency that wanted to respond but was poorly resourced. Frustrating for the industry, for delays in drug review meant real dollars as the patent lives of their drugs were eaten up on the agency clock. And particularly frustrating for patients who wanted access to treatments for their often desperate conditions - particularly AIDS and cancer.

In 1992 the Prescription Drug User Fee Actor, or PDUFA, was passed and has since been reauthorized by Congress. The user fees collected from industry provide FDA with resources--allowing us to hire more reviewers and streamline our management systems. This same statute set very stringent performance goals for shortening the time it takes FDA to review new product applications for drugs and biologics. We were still expected and keep a very high standard for approval.

The average time from submission of a drug application to approval has dropped from about 30 months to less than 12 months. This is significant considering that the number of new products we review each year has increased from approximately 70 applications to 97 applications. The time to market for new drugs has dropped by 18 percent. Because our reviews are more timely, nearly 18 months have been shaved off industry drug development time - resulting in a savings to industry of nearly 2 billion dollars per year.

There are other benefits to having a strong science-driven regulatory agency. A regulatory agency that sets and expects high standards coupled with strong performance stimulates innovation by providing a predictable and level playing field for industry. It has enhanced U.S. competitiveness in global markets and has strengthened the domestic economy as a whole by inviting increased foreign investment in this country.

It should go without saying that the risks of not having a strong scientific foundation supporting our day-to-day decisions are considerable... and far-reaching.

These are just a few examples of how FDA puts science and its scientists to work to solve critically important public health problems. But I'd also like to address a topic where we at the agency need to work more closely with the health care community. That subject is the science of managing risk. This is fundamental to FDA's business and as pharmacists, no matter what direction your career takes, you're likely to be key players in managing the risks of medical product use.

The public expects FDA to assure the safety and efficacy of the medical products that are on the market. In doing so, the FDA spends a great deal of its time and effort balancing the risks and benefits of the medical products it reviews--in other words--considering whether the risks associated with a particular product are reasonable, given the product's expected benefits. In weighing the risks and benefits it's important to realize that safety is not an innate property of any product. While we do assess the safety and efficacy of a product before it reaches the market, and monitor its use once it's on the market, much of the risk management associated with the product once it's approved is primarily in the hands of health care professionals and the patient.

So FDA considers the ability of users to understand the risks and act in ways that minimize them, and the ability of the health care system to effectively communicate both risk information and risk management steps to the public.

A vital part of the post-approval process is adverse event reporting--a process that allows us to discover previously undetected, and unexpected, adverse reactions to products after marketing. As you can imagine, it's simply not feasible for the agency to identify every potential risk associated with the use, and abuse, of a product during the premarket review. Sometimes adverse reactions appear only after the drug is on the market, because the product will be used in numbers of people far greater than were used in the clinical trials, potentially revealing side effects not previously seen. In practice, a drug may be used for indications other than those for which it was approved. No longer in a controlled study, it may used in conjunction with a variety of other drugs, foods, or dietary supplements that could interact with the drug. So we must be alert to new findings after a product is on the market, or in the "post-approval stage."

Doctors, pharmacists, and patients can report serious adverse events to the FDA through our MEDWATCH system, or they can report effects to the manufacturer who, in turn, must report the incidents to the FDA. The agency frequently sends "Dear Health Professional" letters to inform doctors, pharmacists, and others of new safety issues. Sometimes the new information warrants a change in the product's labeling, more careful monitoring of the product on the market, or more rarely, the product's withdrawal from the market.

Communication, feedback and correction--throughout the entire system--about the benefits and risks of a drug or other product for a particular use, is critical to the health care system's effort to reduce the incidence of medical errors. This two-way communication must take place between drug companies and physicians, between physicians and patients, between pharmacists and patients, on the product label and package insert and in any advertisements for a particular product.

Pharmacists have always had a critical role to play here. While physicians often get the credit...and the blame...when it comes to prescribing drugs for patients, we recognize and appreciate the frontline contributions that pharmacists make in interacting with the public and helping FDA do its job.

In closing let me say a word about public service. It's important to keep in mind the very essence of FDA's mission--allowing our consumers to have faith in the safety and quality of the products they buy, receive, and give to their families. We're charged with safeguarding the public health so that Americans can focus on other important parts of their lives. We must continue to work diligently to ensure that the science base of the Food and Drug Administration is strong to provide the kinds of product and policy decisions that Americans both expect and deserve.

As Americans, we're fortunate to live in a society that presents us with countless privileges and opportunities. I like to think that our debts to society can be paid back not only in taxes, but in public service as well. I feel fortunate to have had the education and training, most of it completed here in Indiana, which has allowed me to contribute in a meaningful, and personally very rewarding, way. FDA is one of the few places where one can use science related to regulatory work--assuring the safety and efficacy of products and shepherding needed products to market...serving the American people and touching their lives in many ways every day.

If any of you choose to pursue a career at FDA, you'll find the kinds of rewards I'm talking about. And I assure you...you'll be scientifically challenged, intellectually stimulated, and providing a critical service to the public.

Thank you for inviting me here to share my thoughts with you.