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Jane E. Henney, Ph.D - USP 200 Quinquennial Meeting

"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, Ph.D
Commissioner of Food and Drugs
U.S. Food and Drug Administration
for

USP 200 Quinquennial Meeting

Washington, D.C.

April 15, 2000

Good morning. I'm pleased to have this opportunity to provide remarks on the 100th anniversary of the USP's Board of Trustees.

When I was elected President of the USP Convention five years ago, I would not have imagined that I'd be back here today in a very different role, and I doubt that the Convention members who elected me had in mind that I would leave to go to the FDA. Along those lines, I'd like to acknowledge Dr. Roger Williams, your new CEO. The bad news is that FDA lost a highly skilled scientist and administrator. The good news is that we lost him to an organization where he'll be able to continue to work with FDA...provide exceptional leadership to USP, and serve as a respected bridge between our two organizations.

The FDA and the USP have a long and colorful history of working side by side on public health issues--nearly 95 years. Our history together began in the earliest days of the 1906 Food and Drugs Act and 1938 Food, Drug and Cosmetic Act. It was then that the USP's standards and specifications were recognized, leading to our cooperative efforts on drug standards in the mid-70's, and our complex interactions of today on a multitude of public health issues.

Both the FDA and USP are committed to protecting and promoting the public health. We often pool our energy and expertise in many important activities but particularly in developing standards to assure the quality of therapeutic and nutritional products, and communicating accurate information related to therapeutics and nutrition to the health care community and the public.

Today we face new challenges and can expect many more in the coming years, with changing demographics, an increasingly global economy, changing health care programs and products, and the increased involvement of consumers in their own health care.

There will be continued demands for new standards, and for more and better information in areas such as botanicals and biological products. Over the next 20 years product development will change in ways we couldn't have imagined 10 years ago...forcing more rapid adaptations within--and between--our organizations to respond effectively to the issues of the day.

These challenges will demand that our scientific skills remain current and that we continue to bring the strongest science to bear on our decision-making. We share a vision that is founded upon good science and science-based standards, and these must remain at the forefront of whatever challenges come our way.

One of my highest priorities as Commissioner has been to enhance our science base at FDA-both our internal science capacity and our ability to leverage scientific resources outside of FDA. I believe these improvements will make us a more effective partner to USP.

It should be obvious that if we're to be individually and collectively successful, the FDA and USP must maintain a strong working relationship...being mindful of our separate missions but bound by the common goal of improving the public health.

It's FDA's desire to work cooperatively with USP on issues that are important to consumers, health professionals and the regulated industry. We've done so in the past, on issues ranging from veterinary drug monographs to our efforts to facilitate the transfer of private specifications into public standards that will then become a part of the USP-NF.

As to the present and the future...

We must continually improve and maintain regular and effective communication between our groups. As in any relationship, understanding each other's point of view is key. To this end we've proposed the establishment of an ongoing reciprocal program to orient and update FDA personnel on USP's policies, programs, procedures, and major programs, and vice versa for USP personnel.

In addition, we believe the Ad Hoc Reviewer Program should be maintained and enhanced.

We believe we share common strategic goals related to off-label use of drugs and can also identify collaborative initiatives in response to the IOM report on medical errors.

With regard to the more immediate work before you...FDA is strongly committed to the resolutions we have submitted, and that you will vote on today. Our proposed resolutions include (1) improving communication and sharing of information between USP and FDA in adopting public standards for FDA-regulated products, (2) working with us toward harmonization with major pharmacopeias in Europe, Great Britain and Japan, and (3) working with us to develop guidelines for prioritizing and conducting methods research on botanicals.

We know these are but a few of several resolutions you're considering during this convention. We hope that our resolutions become part of the workplan for the USP and the joint efforts between the FDA and the USP during this next five-year period.

FDA remains committed to our working relationship with USP. We know that a number of the resolutions you will consider deal with issues that require cooperation between our organizations in order to avoid duplication of efforts and to avoid the potential for developing conflicting guidelines.

In closing let me leave you with a challenge. The challenge is this...create an agenda that promotes not only cooperation, but synergy between the Food and Drug Administration and the United States Pharmacopeia. Make this an agenda worthy of the beginnings of a new century--bringing together the best of our past, and the greatest of our desires and dreams--and the energy and commitment to manage what lies ahead.

Having been a part of the USP in the past, I thank you for the opportunity to be here today and the privilege to work with the USP in the weeks, months and years ahead.