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Good morning. I am Sharon Smith Holston, FDA's Deputy Commissioner for International and Constituent Relations, and it is a pleasure to welcome you to our Seminar for the International Community. This is the second time that our agency has brought together members of the international community for a seminar of this kind, and we hope you will find the program informative and helpful to you in carrying out your responsibilities.
The agenda for today and tomorrow generally falls into two groups. This morning's program includes an FDA overview and four presentations on FDA's international programs. The remainder of the seminar is designed to bring you up-to-date on important subjects such as product standards, jurisdiction, approval processes, laws and regulations, foreign inspections, import procedures, and provisions for food safety.
I know that taking two days out of your busy schedules is a considerable investment of time. However, we hope that this seminar will add to your understanding of FDA on three levels: technical -- the way we go about our business; ideological -- our historic experience, and how it has affected the FDA spirit and culture; and, finally, international -- how we perceive our responsibilities for public health protection in a global setting.
As our program suggests, most of our presentations will be focused on the technical side of FDA -- a lot of basic information we hope will contribute to making your job easier. We'll devote much time to FDA's standards, processes and requirements because they are the strands of our strong safety net that's designed to protect the public health and consumers while imposing the minimum of red tape on regulated industries, and allowing international trade to move as freely and fast as possible.
This seminar also should tell you something about the nature of FDA -- and by that I don't mean merely the breadth of FDA's mission, which, as you know, includes consumer protection against health hazards in drugs, medical devices, veterinary products, cosmetics, and 75 percent of our food supply. What I hope will come across from my colleagues' presentations, and from their answers to your questions, is the dedication to vigorous and rigorously science-based public health protection that has been characteristic of our agency for many decades.
When it comes to protection against health hazards, our public expects excellence, and that's what FDA is committed to deliver. To give you an example of what I mean, last year, the very prestigious Pew Research Center conducted a nation-wide poll about constituent attitudes toward five federal agencies, including FDA. Asked whether they "trust FDA to do what is right," 85% of the responding medical professionals; 78% of consumer advocates; 74% of industry officials; and 72% patients answered, "Yes." Asked whether "FDA's decisions use good science," the same approval was expressed by 87% of medical professionals, 80% of patients, and 74% of industry officials and consumer representatives.
We're very proud of this hard-earned confidence in our agency, which comes from two sources. One of them is the strong legal foundation which goes back as far as nearly 100 years; the other is knowledge that FDA will act upon these laws, which are only as effective as we are in carrying them out. It is a responsibility we take very seriously, and I believe our public recognizes that and takes comfort from it.
Last but far from least, I hope that this seminar will give you a sense of how FDA sees its mission on the world scene. During the first five decades of our existence, we were an entirely self-sufficient, typical domestic agency that hardly ever looked beyond the U.S. border. We began recognizing the need to change in the 1960s when our imports of food and other regulated products began to overwhelm our inspection resources.
Faced with the fact that we could no longer fulfill our mission by relying on our own resources, our agency came up with two answers: participating in the development of sound international food safety standards, and negotiating bilateral memoranda of understanding in which our trading partners agreed to ensure that their exports to this country complied with U.S. public health standards.
These two approaches -- international standard-setting and bilateral agreements generally met our needs for many years. By the end of the 1980s, however, the globalization of production, trade and consumption -- plus the rapid worldwide spread of the HIV/AIDS -- clearly required more far-reaching regulatory responses. In 1990, therefore we joined in efforts to harmonize technical requirements and guidelines -- so that regulated products developed in one country could be more easily introduced elsewhere. That concept, as you know, has been embraced all over the world, and it is now being applied to human drugs, medical devices, and veterinary products.
The harmonization efforts, however, still left FDA, and many of our counterparts, with the insupportably expensive and frequently duplicative task of inspecting foreign export facilities. In 1995, again out of necessity, we took another unprecedented step by entering into negotiations to provide for exchanges of inspection documents for pharmaceutical and medical device facilities, and for exchanges of third-party reviews of low-risk medical devices, between the U.S. and the European Union. The Mutual Recognition Agreement that contains these two annexes was signed in 1998, and we are now in the transition period when our EU counterparts and we assess each other's equivalence.
The question you might ask -- and we're asking it frequently -- is, where do we go from here? The answer, I think, is implied in the course we've followed since the 1960s. Our first obligation, obviously, is to make sure that the effort and resources we are devoting to international programs accomplish their goals -- and by that I mean, provide benefits for us and for our partners abroad in the form of resource savings, public health protections, high international standards, and other advantages for which they were designed.
That's what's expected not only by us, but also by our public and Congress. When it comes to the mutual recognition, for example, our legislature has such faith in it that three years ago, it passed a law directing our agency to work toward developing similar recognition agreements with the EU for all products FDA regulates, except cosmetics. But in the long run, the greatest pressure for comprehensive collaboration among regulatory authorities will come again -- as it has in the past -- from new, and more demanding circumstances.
The astonishing technological revolution, which is already upon us, will produce a great variety of products of unprecedented complexity. It will be up to us and our regulatory counterparts to collaborate in judging the fitness of these scientific marvels for the world's consumers and patients. In addition to this emerging, and extremely challenging new public health reality, continuing growth in trade, dramatic increases in Internet usage and the aging population around the world will multiply our workload and add to the pressures on our resources -- and I know from many conversations with regulatory colleagues abroad that our capabilities are already strained to the limit.
Based on the experience of the past 40 years, we at FDA believe that the answers to these new, world-wide tasks will have to be found in even closer cross-border collaboration than we've achieved so far. I would like this seminar be a small step in that direction. I thank you for joining us, and we'll start our program.