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David A. Kessler, M.D. - FDLI Annual Meeting

NOTE: THIS TEXT IS THE BASIS FOR COMMISSIONER KESSLER'S ORAL REMARKS. IT SHOULD BE USED WITH THE UNDERSTANDING THAT SOME MATERIAL MAY HAVE BEEN ADDED OR OMITTED DURING THE PRESENTATION

Remarks by

David A. Kessler, M.D.

Commissioner of Food and Drugs

FDLI Annual Meeting

Washington, D.C.

December 13, 1994

Good morning.

I'm here today to focus on the workings of FDA. I'm going to focus on things that I believe are vital to the Agency's future but which, for the most part, often haven't received widespread visibility.

I am going to give you a lot of details, show you a lot of numbers, a lot of slides. At the risk of being a little long, I hope the information I convey this morning leads to a better understanding of this vitally important Agency.

Five FDLI speeches ago I stood before you and set forth my initial agenda for the Food and Drug Administration.

On that cold December morning, I acknowledged that my first priority was the most difficult to discuss. It was difficult because I knew then, as I know now, that the commitment of FDA employees to their Agency is unmatched anywhere.

My first priority upon arriving at the FDA in December 1990 was to rebuild the Agency's credibility after the generic drug scandal.

This is what I said: "The most important thing we can do to rebuild the credibility of the Agency is to ensure the integrity of its processes."

Today I want to take a moment to tell you something about the integrity of this Agency and its employees.

Over the past two years, six FDA field staff have been offered bribes for special treatment. The products involved ranged from spices and seafood to surgical instruments and foodstuffs.

Six attempted bribes. Six different FDA field employees. One attempt on the West coast, five on the East coast.

In every case, the FDA people did what our bribery awareness training had taught them: They reported the criminal activity to the appropriate authorities and cooperated with the Inspector General's Office.

In subsequent meetings with those who offered the bribes, each employee pretended to accept the bribe. As a result, I can tell you today that seven arrests have been made. Three of those arrested have pleaded guilty, the other four cases are still pending.

The exemplary performance of these six employees speaks for itself. Make no mistake, these individuals, who put their own safety at risk, are heroes in the eyes of this Agency.

Let me move on to the focus of my remarks today: some of the work we have done over the last year, and some of what we plan to do in 1995. And I need to underscore that I am going to be talking about only some, not all.

A good place to begin is the Prescription Drug User Fee Act of 1992 -- what has come to be known as PDUFA. As many of you know, the Act authorizes the Agency to use fees collected from the pharmaceutical industry to expedite review of applications for new drugs and biologics. There has been a tremendous push at FDA to get this program up and running. Today I want to show you some of the progress we have seen so far.

Perhaps the most important early goal of PDUFA is elimination of the user-fee defined backlog.

The Agency committed to clearing a backlog of 696 overdue drug and biologic submissions by July 2, 1995 -- about six and a half months from today. As of November 30, 1994, only 9 of those 696 remain. We are way ahead of schedule. We will meet this goal.

When it comes to new applications for NDAs, PLAs and ELAs, or applications for manufacturing supplements, the performance goals are set for twelve months or six months respectively after the submissions are received and filed by FDA. As a result, we cannot yet accurately measure our review performance for applications received in fiscal year 1994.

However, we now have performance figures for new applications and manufacturing supplements filed in fiscal year 1993.

A second PDUFA goal is to have 55% of NDAs, PLAs, and ELAs received in fiscal year 1994 reviewed in 12 months. We won't be able to analyze how we've done on the FY 94 cohort until 12 months after the last application is submitted -- probably Fall 1995. So the FY 1994 cohort is still work in progress.

But as you can see on this slide, if you look at the applications that came in during fiscal year 1993, we exceeded our 55% goal set for the fiscal year 1994 cohort with the 1993 cohort. So that, too, is good news. This slide also shows the improvement in on-time actions over 1990-91 when no user fee program was in place.

As the next graph shows, our performance in reviewing the 1,252 manufacturing supplements received in fiscal year '93 also represents substantial improvement over previous years. Our goal for manufacturing supplements that is set for applications received during fiscal year 1994 is to have 55% reviewed within six months.

Final analysis is going to have to wait until six months after the last supplement in that cohort is submitted. Yet I can announce today, that as of November 30, 1994, -- two weeks ago -- we already reached the 55% goal for the fiscal year 1994 cohort. The final percentage of supplements completed within six months in the 1994 cohort can only be higher, and in all likelihood will be somewhere between 55 and 70%.

The final PDUFA graph illustrates another important achievement: substantial improvement in approval times. In the FY '93 cohort, 20 NDAs and PLAs were approved within 14 months compared to only 12 in the years preceding PDUFA. Six of these faster approvals followed the second review cycle, and the sponsor turnaround time between review cycles averaged less than 60 days. FDA review time on these second cycles averaged less than three months.

This confirms a basic assumption of the user fee program; cutting review times means quicker approval times for approvable applications.

These improvements in the drug approval process are very important and very heartening and I am enormously proud of the FDA staff who have worked so hard to make them happen. Safe and effective products are getting to market sooner. But a lot of hard work remains to fully realize the goals of the program. We aren't fooling ourselves. We aren't resting on our laurels. It will take an enormous, sustained effort to reach performance levels mandated in upcoming fiscal years.

I want to move on to medical devices where an efficient review process is also a high priority. And today I want to show you some significant progress in the area of medical devices, too.

This slide shows that we have reduced the backlog of 510(k) applications by 75% percent from its peak of 2,000 just one year ago. We are also concentrating our resources on 510(k) devices requiring the most intensive review.

Last week -- on December 7 -- we published a final rule exempting an additional 148 generic types of class I "low risk" devices from 510(k) premarket notification requirements. This makes a total of 441 or 65% of all class I devices that are now exempt from review. We expect this to decrease the number of 510(k) applications by about 600 a year.

In the coming year, we plan to propose additional low-risk products for exemption. This enables industry to market devices more quickly and FDA to use its resources more efficiently.

With the reduction of our 510(k) backlog, we are now intensifying our efforts to improve review times on PMAs.

We have also been successful in cutting our time to process certificates for exports and export permits, as these next slides show.

In calendar year 1993 the average time required for a permit to export unapproved devices was 65 days. In 1994, it was only 16 days.

We have made similar gains with export certificates for approved products -- a drop from an average of 52 days in 1993 to only 10 days in 1994.

And most importantly, the improvements that you've seen in drugs, biologics and medical devices have been accomplished without lowering the high standards that the American people have come to expect.

This is welcome news, but I would be remiss if I didn't also add a note of caution. The progress I have shown you results from management improvements and shifts in resources. However, these internal improvements can take us only so far.

The number of applications and their complexity continue to increase at a phenomenal rate, pushing our resources beyond their limits. To achieve the kind of expedient, effective review process that all of us want, I continue to believe that we need a user fee program for medical devices.

Another very important initiative out of the Center for Devices and Radiological Health is, of course, implementation of the Mammography Quality Standards Act -- MQSA. This is one very important part of the Agency's commitment to improving women's health.

High quality mammography can save lives from breast cancer. But high quality mammography is technically demanding. Two years ago Congress passed the MQSA to ensure that every mammogram in this country is of the highest quality. We have been working very hard over the past year to make that a reality.

We met our October 1 deadline, announcing on that day that more than 95% of the approximately 10,000 mammography facilities have been certified. Today, I can report that about 99% of the facilities have been certified. Some have full accreditation and others have been provisionally certified, meaning their staff and equipments meet quality standards and they have six months to meet other requirements.

Mammography, I want to add, is a user fee program.

Another important area where we have taken steps may be less familiar to many of you. It concerns the regulation of imported products.

The volume of imports into this country has been growing exponentially. Currently, FDA-regulated products account for one out of every three products offered for entry into this country - - a robust 3 million entries a year and growing.

We simply cannot cope effectively with this kind of volume without an automated system, and that is what FDA, together with the U.S. Customs Office and the import industry, have been putting in place over the past two years.

We now have 55 ports of entry on this automated system, accounting for 80% of the FDA-regulated products coming into the country. By the end of next year, every port will be on the system.

This system has transformed turnaround time from days to minutes...days to minutes. At the same time, the system enables us to do a better job of screening for violative products -- we are seeing higher detention rates in participating ports -- and it also generates data that help us analyze longterm trends.

On the international front, I also want to note the accomplishments over the course of the past year on international harmonization of drug regulations and development of international standards for devices, foods, and veterinary medicine products.

FDA has been a very active participant in the International Conference on Harmonization (ICH), the International Organization for Standardization, Codex Alimentarius Commission, and other efforts that are helping to create a unity and order where once a cacophony of differing standards and requirements was the order of the day.

These cooperative ventures will mean that manufacturers do not have to comply with a host of different and sometimes incompatible standards and regulations depending on where on the map they want to market their products. In an increasing number of areas, we are all reading off the same page.

In 1994 in the drug area, for example, FDA published four final ICH guidelines covering reproductive toxicity, stability testing, geriatric testing and dose response studies.

We will be publishing another seven guidelines developed in 1994 in early 1995.

In the device area, international standards were developed covering biocompatibility of implants, ethylene oxide and moist heat sterilization, and heart valves to name but a few.

I've spent the last few minutes reviewing some of our activities over the past year. Let me now turn to the present and two announcements.

First, I want to announce a new policy on pediatric drug labeling. I have had a strong personal interest in this initiative because, as a pediatrician, I know just what a difference it can make in the medical care of children.

When I first came to the FDA I began to ask why it is that drug labels have so little to say about the proper use of drugs in children. The fact is, drug companies usually don't test drugs for safety and efficacy in pediatric populations. They collect data on adults. Pediatricians are left to extrapolate, guess a little, prescribe based on experience, what is in the pediatric literature, or what is known about the drug's effects in adults.

But children are not just miniature adults. You can't simply calculate the pediatric dose based on the dose that is safe and effective in adults. Relying only on information about adults is simply not good enough.

I'm pleased to announce that today we are publishing in the Federal Register a final rule to make it easier for drug companies to include information about pediatric use in the labeling.

This slide shows the various ways a company should now convey information -- or a lack of information -- about pediatric use. Notice especially the second one here. If the course of a disease is similar in adults and children, and the sponsor provides supporting pediatric information, such as pharmacokinetic or safety studies, FDA now will consider approving the product for pediatric use.

Let me repeat: If the disease behaves the same in adults and children, adequate and well-controlled trials to show efficacy may not need to be repeated in children. All that may be necessary under the new rule is information on the appropriate dose and perhaps additional safety information for children.

We hope this provides an incentive for manufacturers to submit pediatric information to us.

This rule is part of a broader FDA initiative to focus sponsors and FDA on obtaining more information on pediatric data throughout the drug development period and in labeling.

One personal note: Much of the credit for this rule goes to a number of folks within FDA. But credit also goes to a brave and courageous woman who died earlier this month -- Elizabeth Glaser, the co-founder of the Pediatric AIDS Foundation. Several years ago, she and I met and discussed the need for more information about the proper use of drugs in children. During that conversation, I promised her that we would move forward.

This rule is only a first step.

We have launched discussions with members of the pharmaceutical industry, as well as the pediatric community on next steps.

The new food label is here. (Slide 15) It is on literally billions of food packages across this country. The food industry has done a remarkable job.

It is enormously satisfying to see those new food labels and we are gratified by the overwhelmingly positive response to them from consumers and health professionals. A recent survey of dieticians, for example, found that almost 70 percent of their clients and nearly two-thirds of the dieticians changed what food they buy as a direct result of the new label.

The second announcement that I would like to make today has to do with compliance with the new food labeling requirements.

Since last August, FDA inspectors have been in food stores and in factories. And today I want to share with you what we have found.

We have examined more than 5,000 products. Less than 1% did not have the new label when they should have had it. We have had to issue only 28 warning letters for failure to display the new label.

Scoring better than 99% is an A+ in any grading system.

Today I am also releasing the results of a survey of 300 food products off store shelves. The Agency received the final report last week, and the news here is also good.

Ninety four percent of the analyses done on fat content found the numbers on the label indeed accurately reflected what was in the package. For calories, it was 93%. Overall, 87 percent of the analyses done on a dozen nutrients found the numbers on the label were accurate.

These results show that consumers can trust what it says on the new food label.

In addition to labels consumers can trust, we also want to make sure they are easy to read.

This is what the new food label should look like on the vast majority of food products. We have been meeting cooperatively with companies to make sure that it does.

Next, I want to move on to the future and the Agency's plans and priorities for the next year.

The starting point for any talk about the future has to be the announcement just a few days ago of FDA's future home. The Montgomery County site selected is Clarksburg.

(Slide 19)
If all goes as planned, by the year 2003 the Centers for drugs, biologics, medical devices and radiological health as well as the office of regulatory affairs and office of the commissioner will be together at the Clarksburg site.

This site was chosen by a panel of five experts -- three from GSA and two from FDA -- who worked for nine months exploring every aspect of the three sites that were under consideration.

The panel weighed the suitability of each site according to a carefully defined point system, considered the results of a detailed environmental impact study, and discussed each potential choice in public meetings with the residents who would be affected by the construction.

Some have questioned why GSA has proposed that we move out so far. While many factors came into play, there are not many parcels of land in Montgomery County that can accommodate 350 buildable acres. This site stood out because the land is continguous and it is the only one of the sites where FDA's buildings would not have to be needlessly broken up by existing or proposed roads.

This site will allow us to be housed so that we can encourage cross-center collaboration in a way that none of the others would.

The process of choosing a new site was independent and rigorous, and confidentiality about the selection was maintained until the end. I received word of the choice in an official phone call Friday morning at 8 a.m., just before the public announcement. I want to express my personal thanks and the gratitude of the Agency for the truly outstanding work of those involved in making this decision.

The new consolidated site is still several years away. Our immediate focus needs to be on our program priorities for the coming year.

Let me set out the top program priorities for 1995, center by center.

One caveat: The list is not meant to be all-inclusive. These are programmatic priorities. In a moment, I will some back to some more specific policy initiatives for the coming year.

(Slide 20)
Our Center for Veterinary Medicine will be instituting changes to strengthen its product approval system -- making it more flexible and decreasing the time and cost required without sacrificing standards of safety, efficacy, and quality. It will also be removing from the market unapproved animal health products that compete with FDA-approved products. A third priority for CVM is to improve the safety of animal-derived foods through increased enforcement.

(Slide 21)
HACCP -- the Hazard Analysis Critical Control Points program -- will be a top priority for CFSAN next year. So will implementation of the dietary supplement regulations. You will also see management improvements in 1995, consistent with the National Performance Review and recommendations of the Food Advisory Committee.

(Slide 22)
CDER has listed four priorities: meet or exceed PDUFA goals, make progress in information technology initiatives, implement Good Review Practice Initiatives, and continue the Agency's efforts on international harmonization of drug regulations.

Let me say a few words about what to expect in the area of international harmonization in 1995. I mentioned earlier that we will be publishing seven additional ICH guidelines. In addition, work will continue on another 14 documents that are at various stages of drafting. Many of these will be completed by the ICH III meeting in Japan in November 1995. Additional topics will also be launched in 1995, on biotechnology, clinical trials, medical terminology, and electronic standards for the transfer of regulatory information.

In 1995 we will also be reaching more Mutual Recognition Agreements with other countries to ensure that their standards for safety are equivalent to ours, with the promise of both freer trade for American food and drug manufacturers and safer products for American consumers.

(Slide 23)
CBER is working with CDER on the same list of priorities. CBER also is looking to implement tissue regulations and establish a gene therapy registry.

(Slide 24)
Our Center for Devices will continue to improve the review and approval process. One priority is to be able to approve most IDE's by 30 days. CDRH will also exempt and down classify products where 510(k)s don't add significant consumer protection. It will implement the mammography standards under MQSA, as I mentioned earlier, and also move forward on design controls as the cornerstone of good manufacturing practices.

(Slide 25)
The National Center for Toxicological Research provides a critical scientific base for our efforts and in the coming year it will be focusing on scientific issues that bear on food safety and drug toxicity. NCTR plans to develop better analytical methods to identify microbial and chemical contamination of foods and other products, expand knowledge on the relationship between dietary modulation and susceptibility and expression of chemical/drug-induced toxicity, and continue to develop new test models to improve our ability to predict and identify toxicity.

Those are some, and I underline the word "some," of our program priorities for 1995. Let me next set out some of the policies that we expect to be working on in the upcoming year.

(Slide 26)
Perhaps our most important initiative in foods is applying the Hazard Analysis Critical Control Points to food safety. Our final HACCP regulations for seafood will be out early next year, and we'll be working closely with the food industry on extending HACCP, as appropriate, to other commodities. HACCP not only gives American consumers greater assurance of food safety; adoption of HACCP as the standard for assuring quality will also help American food producers market their products overseas.

We will continue to fine-tune our food labeling initiative in 1995. We particularly want to address concerns we've heard about how the regulations might inhibit the use of valid health claims on foods.

And, of course, Congress has made changes in the way we regulate dietary supplements. We'll be preparing the regulations to implement that new legislation as well, I hope in a way that improves a relationship that has often been too adversarial. Related rulemaking--to protect children from toxic doses of iron- containing supplements--has received widespread support in its proposal form, from the industry and the public, and will be finalized next year.

We're continuing to promulgate the many medical device regulations required by Congress in recent years. One of the most difficult, user facility reporting of adverse events, is almost ready, and a proposal on the new requirements for mammography facilities and practices will be announced in the Spring.

In the drug and biologics areas, we are working with pharmaceutical, pharmacy and consumer groups on how to get drug information to patients.

We averted a problem last year when we uncovered attempts to import into this country potentially infectious tissue for transplantation. The regulations we published then will be followed this year with a more thorough proposal on human tissue handling, processing, and storage.

And finally, this year Congress made a needed change in the law governing animal drugs by giving veterinarians greater authority to use such drugs outside their labeled indications. We'll be doing the implementing regulations during 1995.

As you can tell, there will be no shortage of activity. We have a very full plate.

The Prescription Drug User Fee Program has made it possible for us to do our job better. But for the most part in the coming year we are going to have to do our job in an environment of limited resources.

Budget constraints are very real. We have to find ways to do more with less.

One way we are trying to make that possible is by streamlining and automating our administrative and support functions throughout the Agency. A very important focus over the past year and in the upcoming year will be on developing appropriate information systems for the Agency.

(Slide 27)
The most ambitious undertaking is the development of what we call the SMART information system, which will in a standardized way allow us to receive and review applications for new drugs and biologics. This system will allow us to support and better manage the entire review process. Four modules of this SMART system will be piloted in the upcoming year.

A full plate. A limited budget. But in the end what gives me confidence about the future is the leadership we have in place at this Agency.

Today, I am pleased to announce a new appointment: Sharon Smith Holston as our new Deputy Commissioner for External Affairs. Sharon has served this Agency for 22 years, most recently as Associate Commissioner for Management. Her knowledge of FDA is invaluable. She brings to her task an outstanding record as a manager. Sharon has earned the respect and admiration of her colleagues and we all welcome her to this new position. In a moment, she will say a few words to you.

I can also report today that we have selected a new Deputy Commissioner for Policy. I expect to be able to announce that appointment soon. These two deputy commissioners join a leadership team that I depend on in everything I do.

Make no mistake: We have in place at FDA a new generation of Center Directors. Over the last several years, there has been new leadership for Biologics, Devices, Veterinary Medicine, NCTR and Drugs. The real future of this Agency lies less in any particular policy, less in any particular system than it does in these Center Directors. For in the end, they are the ones who make the decisions. They are the ones with the final say in their areas. They are this Agency's future.

They are smart, tough, creative and committed leaders who know who to get things done.

Three new Center Directors have been appointed since I last spoke here, one year ago. It is important that you get a sense of them and of our new Deputy Commissioner for Policy first hand and so I have asked each of them to make a few brief comments.

Ms. Holston will begin, followed by Dr. Bernard Schwetz, Director of the National Center for Toxicological Research and Associate Commissioner for Science, Dr. Steve Sundloff, the Director of the Center for Veterinary Medicine, and Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research.