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Jane E. Henney, M.D. - Kansas State 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
for

ASSURING SAFETY IN A RISKY WORLD

Kansas State University

March 9, 2000

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Good evening. Thank you for the opportunity to be here tonight. I appreciate having a chance to return to the midwest-and be among friends and colleagues. We have forged a friendship that has lasted for years. We've sweated through grant getting and celebrated success as we watched many post docs and graduate students participate in a multi-center project.

Dr. Terry Johnson--"Wizard"--has done so many things for this community. Watch him for what is coming. You had your own Harry Potter before Harry Potter was cool. Just watch out if he gets a Nimbus 2000 and starts zooming the skies.

I was asked to share with you some of the challenges facing the FDA today in the area of product safety. It is FDA's fundamental responsibility to assure the safety of the many products it regulates-everything from drugs for humans; drugs and feed for animals--those you consume or those that you adore; biologics such as gene therapy, blood and vaccines; medical devices from tongue blades to pacemakers; to foods and food additives; cosmetics, diagnostics; and some things you may not realize, like microwave ovens and other radiation-emitting devices. In assuring the safety of medical products, the agency is always in the business of weighing their benefits against their risks. And there are inherent risks associated with nearly all of the products we regulate.

You probably go about your day-buying and preparing food, undergoing medical diagnosis and treatment, filling a drug prescription or checking out the latest over-the-counter remedy for baldness, trying out a new shade of lipstick, or using a laser pointer in your latest lecture. Whether you are aware of it or not, your day-to-day lack of worry regarding the safety of products we regulate hopefully reflects confidence that the FDA is doing its job on your behalf.

Throughout its nearly 100 year history, the FDA has enjoyed a high level of trust by the American people, which continues to the present. But trust is a fragile thing and we do all we can and should to assure that we have your vote of confidence in the future. For trust once lost is difficult to regain, as our counterpart regulatory bodies in Europe have experienced in recent years.

Our uniquely American way of representative government has society's expectations--for matters ranging from national defense to public health and safety--reflected in law. A regulatory body is then expected to make these laws operative.

The benefits of a strong regulatory agency such as the FDA are many. The most important benefits are enjoyed by patients and consumers who need safe and effective products. But benefits are also realized from an economic standpoint, for a high-quality, science-based regulatory agency attains credibility and respect on a global scale, stimulating innovation, enhancing U.S. competitiveness abroad, providing a predictable and level playing field for industry, and encouraging increased foreign investment in this country.

What are some of the challenges we face? First and foremost are the tremendous advancements in science and technology. Both government and the private sector have invested enormous resources in biomedical research and biotechnology. The result of this investment is, and will continue to be, a wealth of new products and technologies that will be presented to the FDA for our review and approval before they are introduced into the marketplace.

In order to make these judgements, it is essential that the FDA have the scientific talent to adequately assess the safety and effectiveness of these novel products and technologies. Our scientists must be current in their fields of expertise, quick learners in new areas, and have the creativity and ability to collaborate with other scientists in the FDA and outside the agency. When Wayne Gretzky, of ice hockey fame, was asked what made him a successful player, he said, "I skate to where the puck will be." FDA is in a similar position. We must be able to anticipate and access the cutting-edge science that will be needed to regulate the products of future technology.

Our scientists help to establish standards for product performance and potency, provide data to support regulatory decisions on product safety and information to consumers for the safe use of products, and provide the basis for science-based regulatory policies. The safety of vaccines, acceptable levels of mycotoxins such as fumonisin B1 in corn products, more rapid methods of detecting pathogens in food, better understanding of the significance of antibiotic resistance, are all examples of the products of research from within FDA laboratories. A high quality staff and robust regulatory research program are critical for supporting, in a scientifically sound fashion, the review and regulatory decisions we make every day.

The interaction between our researchers and our regulatory, review and enforcement scientists is becoming increasingly critical given the rapid pace of advancements in science and medicine.

Enhancing the agency's science base has been one of my highest priorities since I became the Commissioner almost one and a half years ago. We at the FDA continue to work tirelessly to make this happen-ensuring that the FDA has the strongest possible scientific acumen-the most capable scientists and the most current and reliable scientific information to support our decisions. Clearly, having a less than excellent scientific capability at the FDA is not an option. Our scientific component includes field investigators, laboratory researchers, reviewers in all areas of FDA's product responsibilities, and all other employees involved in scientific and policy decision-making.

While we must be scientifically sound, consistent, and predictable in our review of products and issues that surround product approvals, it is equally vital to maintaining credibility that our decision-making be open and transparent to the lay public, health professionals, the regulated industry, and any party who depends on the outcome of FDA's decisions. All should have access and the ability to provide input and feedback to us.

Let's talk just for a moment about the judgements that are rendered as we make decisions about which products are safe and effective and ready to move to the market place.

Calling a product "safe" does not mean that there is no risk associated with its use. In reviewing drugs, biologics, and devices, the FDA spends a considerable part of the review weighing the benefits of a particular product against its risks. There is a continuum of uncertainty that is tolerated, depending on the seriousness of the illness. For a drug that is intended to treat a life-threatening illness, and for which there is no other available treatment, more uncertainty would be tolerated. As a medical oncologist, I am well aware that patients faced with grave diseases are willing to assume great risks.

On the other end of the spectrum, little or no uncertainty would be tolerated for remedies for alleviating minor symptoms of the common cold.

I want to assure you that uncertainties about risk do not prevent us from making decisions. An increasing number of drugs, biologics, and devices are being approved every year, many of which are new molecular entities and represent significant advances over those that were available previously. The U.S. now leads the world in terms of timeliness of review of new drugs and biologics without compromising a very high standard of safety. The average review time for drugs is less than 12 months and for drugs for serious and life-threatening conditions less than 6 months.

Cancer is an area where research is paying off in an important way. Just this past year, eight drugs were approved for the diagnosis or treatment of several types of cancer, including early stage breast cancer, relapsed anaplastic astrocytoma, and non-small lung cancer that does not respond to cisplatin-based chemotherapy. The FDA also approved a new biologic for treatment of patients with advanced or recurrent cutaneous T-cell lymphoma, and a new drug-device combination for the treatment of certain precancerous skin lesions.

We approved many treatments for non-cancerous diseases, too, including treatment for HIV infections in children and adults, a new drug for epilepsy, a plasma-derived biologic for von Willebrand's disease-a bleeding disorder, and an antibacterial drug to treat infections associated with vancomycin-resistant Enterococcus aecium. Also on our list of approvals this past year is an immunosuppressant drug to prevent acute organ rejection in patients receiving kidney transplants, a new treatment for osteoarthritis, menstrual pain, and other acute pain in adults, and a new lipase inhibitor to treat obesity.

Other approvals include a variety of diagnostic test kits, drugs for the flu, new products for managing diabetes, new technologies for breast cancer screening, new cardiac devices for treating aortic aneurysms in the abdomen without major abdominal surgery, and for removing blood clots from cardiac arteries or bypass grafts prior to angioplasty.

New ophthalmic devices have also been approved in the past year-implants to correct mild nearsightedness, and an eye laser for correcting myopia in adults. Every one of these newly approved products underwent an extensive evaluation of its safety and effectiveness, and the risks associated with its use.

But at the time of the review it is not feasible, indeed, possible, for the agency to identify every potential risk associated with the use-and abuse-of a medical product. A key question is how extensively drugs should be studied to uncover adverse reactions before approval of a product. It should be obvious that there is less certainty with a study of 500 people than one with 5,000 or 50,000 people. Still, there are risks that we don't discover during clinical trials because some adverse events are very rare or may be only associated with a subset of the population that is unusually sensitive compared to everyone else.

Determining the risk in a population does not necessarily predict the risk for the next individual. And from a practical standpoint, having to include 150,000 human subjects in a study would often be a major obstacle to getting drugs on the market in a timely fashion, especially for rare diseases.

A less obvious reason that risks unseen in clinical trials appear when the drugs are used in the real world is that in clinical trials, the drugs are only studied for the condition for which the drug was developed, and with all other factors carefully controlled. Once the drug is on the market, it may be prescribed for a condition other than that for which it was approved, may be given using a different dosing regimen, or it may be used in conjunction with a variety of other drugs, foods or dietary supplements that could interact with the drug. And the product will be used in numbers of people much greater than were used in the clinical trials, potentially uncovering side effects not previously seen.

These factors must all be taken into account as we work with sponsors of new products to make sure they are safe and effective, and available to patients in a timely manner...yet be alert to new findings after a product is on the market.

The FDA monitors the adverse reactions of drugs for both predictable and unexpected side effects. This requires effort on the part of scientists and medical officers in FDA; physicians and other healthcare professionals in the community; drug manufacturers; and the patients themselves to report any side effects, particularly previously unknown side effects associated with the use of a product.

The recent report from the Institute of Medicine entitled "To Err is Human" has brought renewed attention to the issue of risk management by all of us in the health care delivery system. This IOM report indicates that medical mistakes are responsible for the deaths of about 98,000 people every year.

An important point made in the IOM report is that the majority of injuries and deaths in the U.S. that are attributable to medical products are from known side effects, and not from unexpected ones.

The findings of this study confirmed what the FDA said in its earlier report issued last May, "Managing the Risks from Medical Product Use: Creating a Risk Management Framework".

Since most medical products have some inherent risks associated with their use, some greater than others, as these products enter or are in the market place it remains our responsibility to identify the risks, and communicate that information effectively to physicians, nurses, pharmacists, patients, consumers, and anyone else who may be affected by those risks or their management. Risks involving specific subpopulations of people, for example, children or pregnant women, must be clearly conveyed.

FDA cannot and should not do this work along. The entire health care delivery system must have adequate safeguards in place. This begins with the development, manufacture, and approval of a product, and continues with physician prescribing practices, pharmacy dispensing, and proper administration of the product to patients in a hospital setting, or at home by the patients themselves.

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. Communication, feedback and correction needs to 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 promoting a particular product.

The agency is now committing considerably more resources to post-market surveillance of FDA-regulated products than it ever has in the past. 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, or more rarely, the product's withdrawal from the market.

In other words, products must be developed, tested, manufactured, labeled, prescribed, dispensed, and used in a way that maximizes benefit and minimizes risk.

Managing risks also extends to venues that never existed before. We now have an issue of enormous promise, but also substantial concern-the Internet. In the health care area alone, the explosion of products and services available to consumers with a few clicks of a mouse and a credit card number is truly mind-boggling.

The Internet presents unique challenges to state license boards, health professional organizations, and state and Federal law enforcement agencies.

The sale of drugs and other medical products over the Internet is growing at an astonishing rate. Online prescription drug sales by reputable pharmacists is one area with clear benefits to consumers. Patients can order new and refills of prescriptions, and obtain information on how to use a medication properly, 24 hours a day. This is a real boon for those patients who live in rural areas, those who are clearly disabled or for whatever reason have found that a trip to the corner drug store is not easy. This convenience, access and privacy are very strong and important attributes of this means of transaction.

But, not all Internet purveyors of medical products and advice are as scrupulous as the reputable pharmacist in your corner drug store, for the Internet purchase can bypass all of the public health safeguards set in place for you, the consumer.

This detour around the standard safeguards creates an enormous potential for increased side effects, drug interactions, exposure to impure or unknown ingredients in unapproved drugs, and drugs that are simply not efficacious.

It is not unusual to see web sites that offer drug prescriptions on the basis of a questionnaire alone. Lost are the doctor-patient interaction, the history of the patient, and the physical examination, an accurate diagnosis, and the joint decision-making process to determine the best treatment for a particular individual. Inherent in this is the risk that a person will unknowingly buy a product that is inappropriate for the condition, or is actually contraindicated for that person because of a misdiagnosis or an underlying condition. Hence, the risk increases for serious side effects, drug interactions, and failure to treat the disease.

The sale of illegal prescription drugs is not a new phenomenon in this country by any means. Unfortunately, though, the Internet offers an alarmingly efficient medium for these illegal practices.

What is the FDA doing about this problem?

First, we have expanded our public education efforts to warn consumers about dangerous practices involving Internet sales of drugs that are not FDA-approved, or sites that offer prescription drugs with little or no involvement or interaction with a health care professional. It is critical that we get this message out so that consumers become more "internet-savvy" and less likely to be taken in by erroneous health information-better able to evaluate the credibility of the source, and learn to spot illegal or unethical drug sales practices. Our FDA Home Page is an important resource for the public to gain information about online drug sales. [Buying Medical Products Online--Shop Smart!]

We are expanding our enforcement activities against illegal online sales of drugs through collaboration with other interested parties. We have developed partnerships with the State Boards of Pharmacy, Boards of Health, and State Attorneys General in order to take swift action against the illegal sales of prescription drugs in the U.S. The Attorneys General in both Kansas and Missouri have been very active in this area. But as you may know, state jurisdictions end at the state line, opening up the opportunity for illegal practices to be carried on across state lines. So when the pharmacy is in one state, the pharmacist in another, the doctor in a third, and the patient in the fourth, a Federal presence, whose jurisdiction can span these boundaries, can stop this illegal activity wherever it occurs.

We are optimistic that with this dual approach of using educational and enforcement tools, you will be better protected from some of the dangers associated with online prescription drug sales.

Let's leave the medical area for a moment and talk about risk in the edible world. The FDA is also responsible for ensuring that foods for humans and animals are safe and truthfully labeled. In the case of food additives, safety means that there is a reasonable certainty, in the minds of competent scientists, that the substance is not harmful under the intended conditions of use. Our current laws prohibit the use of food additives that are carcinogenic in animals or humans.

Testing every chemical that may contact foods, for example, in food wrap substances, for its potential to cause cancer in humans or animals would be prohibitive. Instead, risk assessment principles are used to determine if animal carcinogenesis tests are needed. For example, using a procedure known as the "threshold of regulation", a chemical whose use in food contact articles results in a dietary concentration of one half part per billion or less would be exempt from the process for a food additive petition approval. Under another procedure known as the "constituents policy", a carcinogenic contaminant of a non-carcinogenic food additive is permitted if the lifetime cancer risk is negligible.

Thus, the rule of "reasonable certainty of no harm" assures the safety of food without unreasonably restricting the use of chemical substances that may contribute to the safety of foods.

The presence of microbiological organisms such as Salmonella or E. coli 0157H7 in food has received considerable attention in recent years. The FDA has a major effort under way, working jointly with other federal and state agencies, to improve our ability to detect food-borne illnesses rapidly, and to track contaminated foods to the source as fast as possible to prevent further illness. The process for determining safety and risk for chemical contaminants also applies to microorganisms in products. Considerable research is being done to determine the concentration of pathogens in food or other products that represents risk of infection to the consumer.

Finally, I would like to say a few words about dietary supplements. The dietary supplement industry is booming, and while there are likely benefits from some of these products, the potential for exaggerated claims, unpredictable composition, and toxicity are of considerable concern to the agency. There is also a real and growing concern about interactions between dietary supplements and medications.

Dietary supplements represent just one more area where the strongest possible science must be brought to bear on our decisions.

I would like to conclude with a few final thoughts about the importance of strengthening FDA science for a safe and healthy world. It is important to keep the agency's mission uppermost in our minds-allowing consumers to have confidence in the safety, quality, and effectiveness of the FDA-regulated products they buy and use. It is our responsibility to safeguard the health of Americans, recognizing that in today's marketplace, a decision by the FDA truly has global implications.

For each of the issues that I've mentioned tonight that relate to product safety and risk considerations-food, safe use of medical products, predictiveness of clinical trials, the sale of drugs over the Internet, dietary supplements and others that I simply did not have time to cover--each represents its own challenge but all must have the best science brought to bear for decision-making.

We will do our best so that all of you can feel safe in a risky world.

Thank you for the opportunity to speak to you tonight.