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Linda Suydam, D.P.A. - ISPE Annual Meeting, New Orleans, LA

Remarks by:

Linda Suydam, D.P.A.

Senior Associate Commissioner

Food and Drug Administration

for

ISPE Annual Meeting, New Orleans, LA

November 1, 1999

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Good morning. I am pleased and honored to be here, and to bring you the greetings of FDA Commissioner, Dr. Henney. And also, her thanks. Dr. Henney asked me to express her appreciation for all the work you have done in collaboration with our agency -- such as your help with the baseline guides, the SUPAC equipment addenda, and the planning for SUPAC training workshops. The Commissioner is also very pleased that your members around the world emphasize the importance of good manufacturing practices and high engineering and product standards for the production of safe and effective drugs and devices.

At FDA, we are reminded almost daily that in today's world of highly mobile people and goods, effective public health protection must begin far beyond our borders. And of course, our workload never lets us forget that the job of managing public health risks, which is the core of our mission, cannot be done by FDA alone -- that, as a task force reported to Dr. Henney earlier this year, all of us in the health-care community must contribute to that cause.

So it is truly gratifying to have such a partner as ISPE, an organization that understands this need, that cares, and whose work throughout the globe contributes to the quality of public health protection in the United States.

Earlier I mentioned FDA's workload. A major part of my job -- and in fact of our agency's -- over the last year has been the implementation of the FDA Modernization Act of 1997. FDAMA --I believe you heard in June from my colleague Sharon Holston -- is not only affecting everything we do, but also helps us measure how successful we are in doing it. And so I thought I would use this opportunity to give you an overview of FDA's performance for fiscal year 1999, which ended a month ago.

Essentially, the picture that emerges from the fiscal year's statistics is of an agency that is in good health, that has worked as hard at modernizing its processes, and only needs additional sustenance to be ready for the challenges of the 21st century.

To start with two vital signs, our Centers for drugs and biologics once again met practically every review goal under the Prescription Drug User Fee Act which was reauthorized in FDAMA, as we call the Modernization Act.

As you know, the user fee act enables FDA to collect fees for new product reviews and other services rendered to manufacturers. In the past year the Center for drugs approved in the last fiscal year 77 new drugs, including 27 New Molecular Entities, and FDA's Center for biologics approved 30 new medications. The median time for the approval of drugs was just under 12 months, and for biologics a little over 12 and a half months. Many of the products were reviewed in record time.

Our medical device Center also had a good year. It approved 44 new devices, many of which represent the cutting edge of high technology.

Two of our Centers won Hammer Awards from the Vice President's National Partnership for Reinventing Government for "building a government that works better and costs less." One of the awards honored the drug Center's generic program for its recent streamlining and managerial reforms, which have greatly increased the efficiency of the Office of Generic Drugs. Last year, this office issued 269 approvals and tentative approvals. Just think of it! That represents more than one drug approval for evey business day in the year.

The other Hammer Award went to our Center for Veterinary drugs, for measures that have helped protect the United States from the bovine spongiform encephalopathy -- the "mad cow" disease that recently devastated meat production in Europe.

Our Center for food did a great deal of work as one of the leading partners in the President's Food Safety Initiative, a high-priority, multi-agency, comprehensive program designed to increase the already high standard of food safety in our country. The Food Safety Initiative is focused on research and education, on speeding up the reporting and tracking of outbreaks of foodborne illness, and on strengthening the safety of domestic and imported produce and seafood.

Last but by no means least, FDA has begun reaping the first benefits of Commissioner Henney's emphasis on scientific excellence as the basis for sound regulatory decisions.

To give you just two examples: Earlier in the year, our scientists identified a functional domain that mediates the cellular and viral effects of a protein that's involved in the progression of HIV, the virus that causes AIDS. The next step in this research is to find how to neutralize this protein, and thereby slow down the HIV progression.

The other, more recent example, is a preliminary study performed at FDA's National Center for Toxicological Research that produced biochemical and genetic evidence that mothers of children with Down's syndrome have impaired folate metabolism. The finding indicates that the FDA-required fortification of some grain products with folic acid may help prevent not only spina bifida, but also other serious diseases.

Looking at last year's record, one might assume that FDA is what it has always been: a reliable and highly competent agency dedicated to the protection of public health. This picture is true -- we're proud of FDA's traditional qualities, and are determined to keep them -- but it is not the entire picture. The full story of the last fiscal year includes two significant signs that our agency is responding to new circumstances by developing new approaches and new ways of thinking that will substantially change the way FDA carries out its mission.

The new circumstances -- and they have been emerging with increased clarity in recent years -- are primarily related to FDA's severe budgetary constraints, the challenging scientific innovations by the regulated industries, and the appearance of new viruses and harmful bacteria that pose severe public health risks. At the same time, the American public, our consumers have ever-higher expectations of public health protection, as reflected in new congressional mandates for our agency.

The new approach we are adopting in response to these challenges may seem familiar: it is increased use of cooperation based on our recognition that we can no longer deal with all of these developments single-handedly.

Now, cooperation -- as the joint ISPE-FDA projects in recent years demonstrate -- is by no means new to our agency. Our collaborative activities are so far-reaching that currently, we are implementing two agreements for the exchange of inspectional documents with 15 countries of the European Union. And our partnerships and joint activities are so many that in the last five years, FDA has earned more than 60 Vice President's Hammer Awards, most of them for working closely with organizations such as yours, state authorities, and other members of the health care community.

What is new is our effort to place this cooperative and collaborative approach to our mission on a well-thought-out, clearly defined, and systematic basis -- to make collective actions an integral part of the operations of our agency.

The first indicator of this new direction is the report on "Managing the Risks of Medical Product Use" that was produced last May by Commissioner Henney's special task force headed by the directors of our centers for drugs, biologics and medical devices. The task force found that FDA's central risk management functions -- the approval or non-approval of products, and a careful and complete product labeling -- have in the last several decades kept drug withdrawals for safety reasons to relatively unchanged rates of 1 - 3.5 percent.

The report said that this record, although good, could be improved upon, and suggested some ways to accomplish that. But the report also added that once the medical products reach the market, the safety of their use becomes principally the responsibility of health care providers and patients. The fact that FDA's postmarketing surveillance programs could be strengthened -- given sufficient resources -- does not change the need for other members of the health care community to do their share.

The second sign of FDA's new course is the establishment of a special group of senior FDA staff and managers who began meeting in September to examine all aspects of leveraging -- the process of using resources outside FDA to help us accomplish a mission that's vital for all of us, but that FDA no longer can accomplish alone.

We're trying to develop a system that would enable FDA to identify projects suitable for collaborative action; find appropriate partners who would share FDA's interest in performing the necessary work; and then, by combining FDA's and the partner's efforts, achieve synergy toward reaching the public health objectives.

I can't give you the final conclusion of our leveraging think tank because we've only met three times and still have a lot of ground to cover.

But I can mention some of the principles, aims, means and obstacles we are considering in order to make leveraging a growing and reliable part of FDA's operations and resources.

One basic principle we need to follow is that leveraging is not the means of last resort, but a primary strategy. It has to focus on public health aims rather than mere resource-savings or economies of work, and preferably, it has to target areas that offer multiple benefits.

Another challenging aspect of leveraging is that we'll have to learn how to function effectively as regulators and partners at the same time. Leveraging may mean sharing responsibility and control as well as finding new ways of communicating.

Leveraging will probably always involve some degree of uncertainty or risk, but this should not become an excuse for ignoring potential collaboration.

Finally, we anticipate that leveraging will require a deliberate effort focused on building effective partnerships through planning, development, administrative flexibility, and understanding the motivation of the potential partners.

In short, we are charting a novel course toward our unchanged goal of protecting consumers and promoting the public health. And we're not just planning. Only a month ago, FDA took the first step on this road by launching a new training program conducted together with the regulated industries and focused on emerging technologies of relevance to FDA.

The object of the program, which was developed at Dr. Henney's request, is to increase FDA's science base by introducing our specialists to new technologies used in the manufacture of products regulated by FDA. The expected benefits are more timely reviews of state-of-the-art products -- which will enable the firm to market them sooner -- while making sure that they are adequately validated.

The course brought more than 30 FDA field investigators, Center scientists and field lab analysts to a Merck manufacturing plant in Pennsylvania for a discussion on the latest in barrier isolation sterilization methodology, and a tour of the facility. Our participants in the course reported that it met all of their objectives, and that they and their hosts gained better understanding of each other's perspectives on barrier isolators, especially in the validation area.

We're already preparing a second course, this time on new technology in the food industry. The subject of the course will be regulatory applications of rapid screening methods for allergens and microbiological hazards, and it will be held in January at a General Mills facility in Minnesota. In addition, we are planning similar advanced course in the device, drugs and biotechnology areas.

I am running out of time, but I want to say a few words about one critical aspect of the changes taking place at our agency. It has to do with their limits.

While our methods, processes and approaches to issues and problems will continue to evolve, adjust and modify, there are certain fundamentals about FDA that we shall not abandon.

One of them is our dedication to the cause of public health and the protection of consumers, which are the only justifications for FDA's existence.

And the other basic quality to which we'll remain true is FDA's traditional pursuit of excellence. Aristotle wrote, "we are what we repeatedly do. Excellence, then, is not an act, but a habit."

After 93 years of striving to meet the highest standards, the quest for excellence is our strongest and most enduring mainspring.

Once again, thank you, and best wishes for the remainder of your conference.