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Jane E. Henney, Ph.D - FOOD AND DRUG LAW INSTITUTE

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

Remarks by:

Jane E. Henney, Ph.D

Commissioner of Food and Drugs

U.S. Food and Drug Administration

for

FOOD AND DRUG LAW INSTITUTE

Washington, D.C.

December 16, 1999

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It is always a privilege to be invited to address this group. But, it is a unique one this year, at the eve of the new century, as we all enjoy the opportunity to reflect on past accomplishments as well as shortcomings, and look forward to the challenges that lie ahead. Last year, I outlined my five priorities for the coming year. A great deal of the Agency's time, energy, and attention has been dedicated to those five areas: full and complete implementation of the Food and Drug Administration Modernization Act of 1997, consistent with both the letter and spirit of the law; strengthening of our science base, thereby ensuring that all of our review, regulatory, and policy decisions are grounded in science; the protection of our nation's food supply and blood supply, and implementation of the Administration's initiative on tobacco.

Linda Suydam will provide you with full details of our activities and achievements related to the Modernization Act. Strengthening science has had an equal amount of our attention and energy. For it will be only if we work from a position of scientific strength that we will be able to make correct decisions that relate to to assure that all of our decisions can best assure safety--that critical balance of benefits and risks, whether with food, blood or a medical product. This matter of the management of medical risk has been given renewed attention with the recent Institute of Medicine report, "To Err is Human." This document frequently references a report issued by the Agency last May, entitled, "Managing the Risks from Medical Product Use: Creating a Risk Management Framework." Both reports assert that a great number of people die unnecessarily each year from medical mistakes--the IOM report asserts that up to 98,000 people--which is more than that from breast cancer, AIDS, or highway accidents.

We know that all medical products have inherent risks associated with them. We at FDA cannot make these risks go away--and we should not imply that we can. Instead, we need to make clear what the risks associated with a given product are, and communicate that information as effectively as possible to all involved. One of the greatest areas of concentration at FDA has been--and will continue to be--ensuring that we maintain a proper approach to risk-based decision-making.

It is important to note--and the IOM study also underscores this point--that the majority of injuries and deaths in this country from medical products are from known side effects, not from the unexpected ones. Therefore, although it is imperative that we maintain FDA's high standards in its premarket decision-making, it is equally important to look at whether risks are managed throughout the health care delivery system and whether the entire system has adequate safeguards in place. Clearly, there is more that we all could be doing to minimize the risks of injuries and deaths associated with medical products, due to both known risks and medication errors.

Both reports emphasize that all participants in the medical product development and health care delivery system have a role to play in safeguarding the public health by making sure that products are developed, tested, manufactured, labeled, prescribed, dispensed, and used in a way that maximizes benefit and minimizes risk.

FDA is responsible for the approval decision--ultimately deciding whether a product's benefits outweigh its risks. However, once a product is approved, although the manufacturer and FDA continue to monitor carefully for unexpected adverse events, management of the risks of the product in use is primarily in the hands of health care professionals and the patients themselves.

When adverse events do occur, we need to assure that there are feedback loops throughout the system so that these events can be effectively communicated and acted upon. Doctors, pharmacists, and patients can report serious adverse events to the agency through our MedWatch system, or they can make a report to the manufacturer. "Dear Health Professional" letters may be used to inform doctors, pharmacists, and other practitioners of a new safety issue. And, if the new issue alters the risk-benefit ratio, we must consider certain actions, such as revising the labeling by, for example, adding black box information, or in rare instances, requiring the drug's removal from the market.

Everyone involved in the health care delivery system must help to ensure that patients and consumers are aware of the risks associated with medical products. Effective reporting of adverse events will also be extremely critical as we work together in the protection of the public health.

In addition to our efforts devoted to the Agency's priority areas, I would also mention that the Agency is devoting a great deal of energy to several other high-profile matters--such as the development of a regulatory framework for dietary supplements, the internet marketing and sales of medical products, foods that have been produced using the tools of modern biotechnology, and reuse of a single use device. It takes talent, energy, commitment--and, yes--resources to meet the challenges of today--but are we prepared for what is next in this rapidly changing world?

As I considered the answer to this question, I reflected not just on this past year--or on the one that lies ahead--but this past century of challenge and change. The agency has always had to be prepared for change and the unexpected. Who would have guessed what was to come as Harvey Wiley assumed the leadership of the Bureau of Chemistry. The country didn't have a Federal Food, Drug and Cosmetic Act--let alone the Food and Drug Administration Modernization Act. Although Dr. Wiley firmly believed that science is the best means for grounding our decisionmaking, this was quite counter to the thinking of the time. Today, we accept this as fact. At the turn of the century, our nation's food supply was largely unregulated. There was no apparent need for the regulation of blood, for the science of transfusion had yet to come into full flower. And tobacco was a topic discussed only in terms of its recreational use--and not yet recognized as a threat to public health.

But, we need to assess both our attitudes and our readiness for further change as we encounter shifting demographics, emerging new diseases, global markets, free and open travel, and increased knowledge that comes from the nation's tremendous investment in research. Yes, a regulatory agency must be prepared to change and adapt, but it also must be equally firm in what must be maintained and preserved. Therefore, let us consider those items that need to endure in the years ahead.

What are the hallmarks of a strong, high-performance regulatory agency that serves the public well? First, the highest of standards for ourselves and our work must be expected. Regulated products must also meet high standards of review before entering into the marketplace. The Agency's actions, whether in review or compliance, should be both timely and predictable. A strong and credible regulatory agency should utilize open and transparent processes permit all to be heard and actions understood. While there may be a disagreement about a specific process or outcome, it is important to know that consumers and industry have had the opportunity to participate.

A public health regulatory agency like FDA must define and maintain "true north" values in order to sustain consumer confidence in the agency's commitment to protect and promote the public health. There are three such values that have been and should continue to be the agency's bedrocks: credibility, integrity, and independence. Credibility--both our scientific skills and knowledge, as well as our commitment to meeting society's needs in protecting the public health must be sound. Integrity--people working at FDA and those who serve on its behalf must act and take actions that are above reproach. We can ill-afford to have any questions raised regarding our intent, or any assertions about potential or real conflicts. Independence--a strong regulatory agency must be able to exhibit and exert independence free from political overtones or conflicts of interest by any parties involved.

These values help to guide the agency in the right direction, and help shape the culture of an organization. Thus, the workforce of FDA, at any point in its almost 100-year history, has been committed to the protection of the public health, using scientifically rigorous methodology to underpin its decisions.

As we approach the next century, there is no need to change what the Agency is expected to do. But, we intend to increase the opportunities to expand our ability to do our work effectively, while also making efficient use of our resources. This is not a means to shirk our responsibilities, but expand our capabilities--using our intellect, time, money and resources in a manner that maximizes their value.

Such initiatives are not new to the Agency. In the early 1970's, under Commissioner Edwards, FDA expanded its use of outside advisory committees--harnassing the intellectual capabilities of others to assist in our product reviews.

During the 1990's, we have seen several examples of partnerships that leverage outside resources:--the Moffett Center--a government/academia/industry collaboration has proven to be a crucial asset providing critical information regarding our material quest for improved methods, particularly in the protecting and enhancing of the safety of food. JIFSAN--a partnership with the University of Maryland involving work in the areas of risk assessment and education in the Food Safety Initiative--working with states and state contracts to develop the highest of standards. Implementation of the Mammography Quality Standards Act--the MQSA program--working with private and state accreditation bodies to ensure that mammography facilities meet the quality standards FDA has developed. The agency approves those private and state bodies for accreditation activities, and also contracts with state health agencies to carry out required inspections of local mammography facilities. The Center for Drug Evaluation and Research's Product Quality Research Institute--or PQRI program--a non-profit corporation whose mission is to conduct research to support science-based regulatory policy regarding product quality information. Our National Center for Toxicological Research has also developed many programs that foster collaboration and leverage outside scientific expertise--including risk assessment research projects involving study of the carcinogenicity of several types of products.

These types of collaborative work, tapping the expertise of those outside the Agency, permit FDA's limited resources to go further, and affords the Agency opportunities to reap the benefits of a wide range of experience, expertise and energy from the greater scientific community, while maintaining appropriate oversight of our legal and regulatory obligations.

In coming years, we intend to explore additional areas that would expand our initial collaborative efforts. We welcome ideas and opportunities to further develop our capabilities.

As we look forward to the promise and opportunities of the years ahead, I am reminded of an inscription at a cathedral in Surrey, England, which states, "A vision without a task is but a dream, a task without a vision is but drudgery, a task and a vision is the hope of the world." I look forward to working together with you as we all do what we can and should to provide hope and health to the public.