Remarks by:
Jane E. Henney, Ph.D
Commissioner of Food and Drugs
U.S. Food and Drug Administration
Washington, D.C.
December 12, 2000
Good afternoon. I appreciate the opportunity to be with you today to discuss some of the challenges FDA faces in the new century.
I don't believe I need to introduce you to the world of the FDA. It seems we're always in the news. Americans know who we are and what we do. In the spring of 1999, the group Research!America queried Americans about the name of the government agency that reviews new drugs and devices before they reach the U.S. market. Seventy percent of respondents correctly identified FDA as that agency.
Given this level of awareness, it should come as no surprise that Americans have very high expectations of our work and of the products that reach the U.S. marketplace. Their expectations are uniformly high, whether the product in question is manufactured at home or abroad, in Geneva, Switzerland, or Geneva, New York.
To meet such high expectations, FDA must earn the trust of consumers. Day-in and day-out, this proud agency must prove that it is up to the daunting challenges it faces.
A recent survey of five Federal regulatory agencies was conducted by the Pew Research Center and Princeton Research Survey Associates and showed that FDA is doing just that. The survey found widespread skepticism about the performance of government in general. Only 28% of consumers, 26% of physicians, and 26% of surveyed industry officials said they trusted the federal government to do what is right. Sixty to 70% of them considered it "usually inefficient and wasteful."
In contrast, from 72 to 85 percent of consumers, health professionals, patients, and industry representatives said that they trusted FDA to make the right decisions. The results placed FDA at the top of the charts, with an overall favorable rating above 80%, more than twice the approval rate of the entire government.
How has FDA earned these high marks from the public it serves? How will we continue to maintain this confidence in our rapidly changing world? These are the questions I want to explore briefly with you this afternoon.
Forty-two years ago, India's Prime Minister Nehru noted that "The basic fact of today is the tremendous pace of change in human life." Looking back with the benefit of hindsight, all we can say is that change represents an even greater fact of life today.
It's fair to say that the new century presents FDA with major changes and unprecedented challenges. These include:
This afternoon, I'd like to discuss four fundamental principles that, I believe, will assure that FDA maintains the trust of the American public and the respect of our counterparts worldwide.
First, Ground Decisions in Science. FDA is held in such high regard because we ground our decision-making on scientific evidence and on assessing risk, whether we're reviewing a new drug, deciding about the safety of a food additive, deliberating about public health policy, or taking an enforcement action.
FDA is expected to stand in judgment of the products that result from traditional development in the areas of pharmaceuticals to therapeutics developed as a result of modern biotechnology, such as gene therapy. The mapping of the human genome and exploiting the knowledge to develop new therapeutics and diagnostics has already spawned the burgeoning fields of genomics and proteomics.
The ability to miniaturize has brought nanotechnology. Artificial intelligence. Robotics. Products on the near horizon will no doubt meld all three: nano-robots that can enter the circulatory system, delivering just the right amount of drug or gene product to the right place.
Those who make decisions at the FDA about such traditional or complex high tech products must be scientifically equal to the intellectual cognitive development that has invented these advanced technologies as we judge which products are ready for the marketplace. If we are not scientifically strong, our decision-making will become risk averse, or - what is worse - simply wrong.
The Pew survey I mentioned earlier revealed that three out of four respondents overall agreed that FDA bases its decisions on good science. That is the key. Trust and confidence are earned by relying on science, not whim.
Our continued credibility with the public depends in large part on our scientific and medical expertise to make the right calls in a timely fashion.
The second principle for maintaining trust is to increase our openness and transparency. The FDA enjoys a worldwide reputation for using processes that are open and transparent. Some thirty years ago, FDA pioneered the use of open, public advisory committee meetings, where technical exerts as well as ordinary citizens could discuss crucial matters of science and policy in a public forum. We had one of the first formal consumer affairs offices in government. Through notices published in the Federal Register, and in notice-and-comment rulemaking, our everyday business is a matter of public record.
FDA's website, launched in 1995, provides another essential way of opening up the agency to the public we serve. The FDA site now comprises more than 110,000 documents and receives more than 60,000 visits daily. Perhaps even more impressive is the fact that last month, more than 800,000 visited the site, with one out of five visiting more than once.
Our website has received numerous awards from such quarters as Popular Science magazine, the Dow Jones Business Director, and Tufts University's Nutrition Navigator. Moreover, it is linked to by 8,000 other health, consumer, medical, and educational websites.
In this spirit of openness, FDA is posting on our website materials to be discussed at upcoming advisory committees, so that all interested parties can see, in advance, detailed information on--not just the agenda--about the issues to be discussed. We are moving aggressively to make available even more information once a product is approved. Our goal is to provide as much information as possible concerning the basis for our decisions, and to put that information on the web for all to view. In addition, we are constantly adding new types of documents to our electronic reading room, including transcripts of advisory committee meetings, as well as enforcement actions such as warning letters.
The third principle--Increase Effectiveness by Leveraging. As elder statesman and presidential advisor Bernard Baruch said, "The highest and best form of efficiency is spontaneous cooperation of a free people." In the context of FDA's public health mission, this means working with partners who share our commitment to public health, at every step along the way to ensure consumer protection.
Leveraging allows FDA to bring a wider range of scientific thinking to bear on public health issues. It is not only a smart way to do business, it is critical to our ability to protect and promote the public health. I mentioned earlier that our commitment to assuring safe products rests squarely on our ability to keep pace with the explosion in scientific advances - and then to use that knowledge to assure safe products. This means that we must apply and expand our intellectual capital at every point in the process. Because when consumers buy food items, drugs, or medical devices, they're purchasing not only the product itself, but FDA's assurance that the product is safe.
We intend to increase our ability to do our work as effectively and efficiently as possible. Leveraging is not a means to shirk our responsibilities, but to expand our capabilities.
One example of a leveraging initiative is the collaboration among industry, academia and the FDA is the Moffett Center. The Moffett Center has focused on collaborative studies emphasizing the safety of food processing and packaging technologies and related outreach. Moffett research projects have made significant contributions to the public health by developing processing techniques to prevent contaminants in sprouts and fresh apple juice, as well as a special type of irradiation that is particularly effective in eliminating pathogens in pre-packaged meats.
Another example involves FDA's implementation of the Mammography Quality Standards Act. Working with private and state accreditation bodies to ensure that mammography facilities meet the FDA quality standards, FDA approves private and state bodies for accreditation activities, and also contracts with state health agencies to carry out required inspections of local mammography facilities. The result: a high quality standard for mammograms for American women, and an efficient use of public health resources.
Finally, the fourth principle in maintaining trust is to expand the traditional mission of domestic consumer protection. For nearly 100 years, FDA's mandate has been to provide consumer protection within our own national borders, but our work has long had worldwide implications.
We have had an international presence from the agency's origin during the early twentieth century. FDA led the way in the techniques of analytical chemistry needed to detect contaminants and bacteria in food. FDA has long provided the public health gold standard for the world, whether in reviewing drug products for safety after scores of children died from poisonous formulation of a sulfa drug in the 1930's, or later, in reviewing drugs for effectiveness after the thalidomide tragedy in Europe.
More recently, FDA streamlined drug review processes under the terms of the Prescription Drug User Fee Act of 1992 - a statute whose mandate was renewed in 1997. With the user fees provided by this legislation, FDA has been able to hire new drug reviewers and support staff. The result is that we now make decisions more quickly and more predictably, while maintaining the same high standards for product safety and effectiveness.
In the past eight years, the average time from submission to approval for new drug products has dropped from about 30 months to 12 months, decreasing by 18 percent the total time to market for new drugs. U.S. drug firms nearly doubled the rate of introduction of new molecular entities - shorthand for the drugs that are truly novel - and the U.S. has become the preferred country for the introduction of new pharmaceuticals. In 1998, approximately 75 percent of these new molecular entities developed worldwide were first launched in this country.
FDA is also the world model for food safety regulation. In the wake of recent European food crises, BSE or "mad cow disease" in cattle and dioxin in meat and dairy products, European Commission President Romano Prodi advised the European Parliament that one way to prevent more food crises in the future would be to establish a European agency modeled on the FDA. Numerous delegations have visited FDA over the past year on this very matter.
FDA has also worked closely with international organizations to harmonize requirements and standards for the products we regulate. This work recognizes not only the international reach of our regulated industry but also our collective need to share expertise concerning new products in both the pre- and post-marketing phases alike.
In the area of drugs and biologicals, we now have more than 50 agreed-upon guidelines covering very specific topics. We have created standards to facilitate the electronic transfer of information among companies and regulatory agencies around the world.
Recently, we reached agreement on a "Common Technical Document" that will standardize marketing applications across several countries. With such a core document, a pharmaceutical firm seeking approval of a product in one or more of the participating countries will be able to submit essentially the same document to each country.
While the original participants in these endeavors included the countries of the European Union, Japan, and the United States, the influence of the International Conference on Harmonization (ICH) is spreading far beyond these regions as other nations build their regulatory infrastructures.
ICH member countries have developed a common international medical dictionary - MedDRA. Developing a common medical terminology for use by all three regions may not seem difficult, but in reality it was no small feat. Different medical phrases such as "heart failure," "heart attack," and "cardiac seizure" may seem almost identical, but they convey subtly different meanings. Now that we have standardized definitions for adverse events around the world, we have taken a major step forward in our ability to monitor unintended and possibly unexpected medical outcomes of drug therapies.
The next major thrust will involve harmonizing the submission of postmarket data. The periodic safety report, now being developed, will be a common core document that will in essence allow a company to create one adverse event report and submit it to all participating countries.
These kinds of activities prepare us for a far different future of cooperation, permitting us to successfully bridge differences in government, language, and culture. In short, they prepare us for what is to come by providing a blueprint for harmonization around the world.
We've made progress in the medical device arena as well. Along with our counterparts from the EU, Japan, Canada, and Australia, we are developing protocols that will permit harmonization among these five entities and their regulation of medical devices.
Our work and impact have been greatly magnified because of the nation's aggressive trade policy. This globalization of trade further highlights the need for a strong and robust FDA. As trade agreements and policies are negotiated, it's essential that a scientifically strong regulatory agency have a strong voice on matters that will affect the health of the public. This is most important at three critical junctures:
In short, FDA must speak with a strong and credible scientific voice at the negotiating table or at the time of dispute resolution.
The message I'd like to leave with you is this: as a worldwide leader in public health, and at a time when science and technology are advancing at an astonishing rate, the need for strong science at the FDA has never been greater.
It's not just that FDA must promote and protect the public health within our borders, as we have done so well for nearly a century. The crucial role that we now must play extends all the way around the world.
Our global leadership role means we have enormous potential for improving the public health worldwide. It also means our decision making has enormous economic ramifications for the global industries we regulate.
Investments must be made to keep this agency strong. But the returns on that investment will be an agency equal to the challenges it faces and able to keep the most important vote-that of confidence and trust from the American consumer.
Thank you for your invitation and attention.
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