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Jane E. Henney, M.D. - GLOBAL HARMONIZATION TASK FORCE

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 delivery.

Remarks by:

Jane E. Henney, M.D.

Commissioner of Food and Drugs

GLOBAL HARMONIZATION TASK FORCE

KEYNOTE ADDRESS

Jane E. Henney, M.D.

Bethesda, Maryland

June 29, 1999

________________________________________________________________

Good morning. It is a pleasure to join with Dr. Jacobson in welcoming you to this the seventh meeting of the Global Harmonization Task Force. We are very grateful for and honored by your presence. As many of you know, I began my career in government here at the National Institutes of Health, and have often seen successful public health innovations and public policy consensus come from discussions on this campus. I have no doubt that this week's session will lead to a similar outcome.

I would like to acknowledge the many officials who have made a great effort to be here. Today, we must reach across boundaries of language, culture, and national borders to harmonize regulatory practices. The importance of doing so should not be minimized. International harmonization can not only promote, but enhance the public health when countries are able to agree on the essential principles for safety, effectiveness, and quality. When we engage in interactive discussions regarding our individual countries' requirements and more thoroughly understand and appreciate why they are required, agreement can emerge that adopts the best practices of each participant and results in the best approach to health protection. This is to everyone's gain.

Harmonization efforts can also help governments operate more efficiently--for we are making use of one another's expertise and experience. Such discussion, deliberation, and decision-making also helps to establish trust-- critical element that must be present if we are to use one another's inspection reports and other assessments. By effective harmonization, we in governments are spared the task of each inventing an approach to a common problem.

This increased harmonization is not only beneficial to public health and government efficiency, but can be effectively translated into lower health care costs. Through our development of agreements on standards, Good Manufacturing Practices/quality assurance, and pre-market approval dossiers, companies or sponsors will not have to face different requirements from different governments as they participate in today's global economy. International harmonization contributes to the rapid entry of medical technology in health care facilities around the world. This is a plus for patients everywhere.

The Global Harmonization Task Force has enjoyed many successes in its first seven years. By sharing individual and collective experiences in managing device regulatory systems, new light has been shed on ways we can work together and do our jobs more effectively. The GHTF has become an invaluable forum for the exchange of innovative ideas and for reaching international consensus on approaches to assuring medical device safety and quality.

Thanks to the work of the GHTF, the world has a harmonized approach to several important areas: quality systems/GMPs, medical device experience reporting, and inspection audits. A great deal of progress has been and will be made during the next week in the area of essential requirements for devices. We also look forward to continued work on other issues relating to device classification, premarket approval, and standards.

Our collaboration enables other nations beyond those represented here to pattern their regulatory programs on harmonized approaches that have been shown to be successful. This outcome is critical to control international proliferation of device regulatory systems that differ from each other.

We have experienced success but, many challenges lie ahead. The Global Harmonization Task Force is a relatively young organization, but at a point in its development where procedures need to be adopted. During this week's meeting, efforts will be made to finalize document procedures in GHTF, and continued discussion of other procedural issues.

At FDA, we have been working on many different aspects of recognition of standards and premarket approval decisions. The Center for Devices and Radiological Health has engaged in bilateral exchange of device program specialists in an effort to broaden the participating agencies' understandings of the processes and policies of the other.

In 1995, the Agency began a three-year pilot program in which established and appropriately credentialed notified bodies can substitute for FDA review staff in conducting premarket evaluations. This pilot initiative has focused on products of lower risk, and leaves final market clearance decisions to FDA. The U.S. Congress embraced this FDA initiative--"codifying" it and expanding it in the Food and Drug Administration Modernization Act--a major piece of legislation enacted in 1997 that transformed many FDA programs. This new law has already helped us recognize more than 400 high-quality voluntary consensus standards for medical devices.

The changes we've made reflect a desire to adopt more efficient and effective ways to protect public health, and to work more with others to efficiently use our own resources. These examples also serve to illustrate that the strong commitment of the Food and Drug Administration to harmonize our regulatory practices.

I would like to take a moment to recognize the extremely valuable contribution on the part of industry. Over the past several years, medical device companies have been sending their experts to GHTF study group meetings around the world where, along with government's experts, they have collaborated in the creation of the excellent documents before us today.

While it is the responsibility of various governments to decide which GHTF documents will ultimately be adopted as regulations or guidance, there is no way that this harmonization forum could function without the support and insights of industry. We at the Agency also continue to welcome input from our other stakeholders, including patient, consumer, and health professional groups to these deliberations.

I would like to thank the many people throughout FDA who have devoted long hours to preparing for this week. I'm sure your meeting will benefit from all their efforts.

Again, I would like to extend a warm welcome to the many delegates from other countries--government officials and industry alike. I am sure you will have a productive week of work, but I also hope that you have some time to enjoy our nation's capitol. Thank you very much.