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Michael A. Friedman, M.D. - Association of Food and Drug Officials

Michael A. Friedman, M.D.

Acting Commissioner

Deputy Commissioner for Operations

Food and Drug Administration

Rockville, Maryland

To

Association of Food and Drug Officials

Williamsburg, Virginia

June 8, 1998

There is a strong and historic relationship between the states and the Food and Drug Administration. Without flattering you, I want to acknowledge that this is a sophisticated audience that understands FDA’s strengths and its weakness, our conceits and our concerns, our aspirations and realities. I am not going to give you an unrealistic talk about how wonderful everything is or is going to be soon -- but I wish to convey an authentic sense of enthusiasm and an appreciation for the opportunities that lay before us. And I want to engage you in the process of helping us make FDA an even stronger public health agency.

AFDO is a meaningful stakeholder of the FDA. We share common values about promoting and protecting the public health. Our relationship is a success story; a model of collegial engagement and it is a relationship that we must continue. FDA relies on this relationship because we often need your help at the state and local level and because you often bring important skills and insights.

This collaboration has served the public well. In the last few years especially, despite their own budgetary limitations, the states you represent have often stepped up to the plate when things needed doing to protect the public health. This despite competing worthwhile needs. You have made significant contributions. You have our appreciation and you should take pride in that.

Many joint federal-state projects have gone well over the years and the agency would like to do more if the resources become available. The mammography inspection program is a particular success. Through state contracts with FDA, state officials inspect every mammography facility in the United States every year. That program has provided unrivaled protection of women from the harm of inadequate mammograms.

Until recently, FDA had contracts with three states, California, Texas and Colorado, to help FDA conduct inspections of medical device manufacturers. Although successful, budget priorities forced FDA to cut funding in the current fiscal year for this program. That was regrettable and we would not have done it if we could have found another way. Fortunately, it looks like the states are going to continue the inspections through joint work planning and FDA will continue to provide training support.

With all the rhetoric about the low number of FDA inspections in certain domains, the public could get the incorrect impression that inspections are not being done and that they are not being protected. That is untrue. With the support of the states, there is a virtual army of inspectors out there helping to protect the public health.

One of the most important roles for the states is in food safety. They are working with FDA to cooperatively conduct inspections under the seafood HACCP program. Those are among the most sophisticated inspections anyone is doing anywhere. You should be proud of your involvement. In addition, the retail food inspection program would not exist without the state and local officials – nor would inspections both under contract and under state regulations of food processors, wholesalers and warehouses.

But realistically, I am sympathetic with the difficulties you face. I know that many state programs have suffered the same kind of budget constraints that we struggle with at the federal level. And I know that some of the states were distressed when the Food Safety Initiative was launched and they stepped up to shoulder their share of the responsibility but few resources were made available in the FY 1998 budget. Again, I understand that frustration. Together, I hope to find ways to get the resources we all need to carry out our responsibilities. But we also have to accept that budgets for joint federal-state efforts have been a challenge and probably will continue to be a challenge.

The key reality of the federal-state partnerships is that they are mutually beneficial -- sometimes proceeding smoothly, sometimes not -- but always valuable and capable of accomplishing a great deal. That must continue.

What does FDA envision for the future? If the money becomes available at the state level or at the federal level to contract with the states, a program of joint inspections where state officials could become involved in Good Manufacturing Practice inspections of many FDA regulated products is envisioned for the future.

Food, of course, will remain an important priority. AFDO's outgoing president, recently wrote to me to suggest the need for new partnerships that are vertically integrated for the food safety system. Clearly, with the states playing such a substantial role in the nation's food safety programs, such integration is attractive. FDA needs to examine more closely the issues of vertically integrated inspection programs, from the federal level to the state level, with the proper sharing of workloads, and hopefully, resources.

While I don’t want this to be a budget speech, I do want to let you know that we are seriously looking for ways to find more resources for increased data sharing, training, and inspections at the state level. There are some proposals being considered in future budget request, but I can't talk about them in any detail at this stage in the process. I also recognize that you have heard these kind of promises before, but I want you to know that FDA understands all too well the resource problems and will do whatever we can to help.

I know there has been concern over the years about the evenness of inspections in different states. FDA, as well as the states, wants there to be uniformity in the agency's inspection program. The program of certification of FDA inspectors is moving forward. The program of formal education, on-the-job training and rigorous testing is paying off. This started out with medical devices, but it has been expanded to include seafood HACCP and blood and biologic products.

Unfortunately, this kind of training takes a lot of time and, of course, money. The payoff, however, is worth it. The formal training helps ensure that there is uniformity in FDA inspections from region to region. We are also looking to you to see if some form of this program can be expanded to include staff at the state level.

One of the main issues of this year is the Food Safety Initiative. The President has made it clear that the safety of the nation’s food supply needs to be a major priority for all of us. The Center for Food Safety and Nutrition is moving forward with its contribution to the national effort. The President has requested $50 million for food safety next year. Center director Joe Levitt will tell you about the details in his talk.

As you know, the National Academy of Sciences has initiated a study of whether there should be a single federal food agency and if the answer is yes, how it should be structured? Unfortunately, the congressional legislation that called for the NAS review did not specifically acknowledge the substantial role that the states already play in food safety. I think that it is important that the states' role be recognized in their deliberations. I understand that AFDO has asked to be involved in this effort and I commend your leaders for understanding that this report is probably going to be important.

And, of course, the tobacco initiative is moving forward. We are all waiting to see if Congress will enact comprehensive tobacco legislation. Certainly, the President has been pushing hard for a solution to adolescent use of tobacco products.

The FDA tobacco rule -- which was affirmed in part by the district court but challenged at the appellate level -- is still awaiting a decision by the courts. The appeals court will be rehearing arguments this week.

Meanwhile, FDA is proceeding with enforcement contracts with the states to implement the access provisions the court allowed to go into effect. There are now 13 states under contract to conduct compliance checks this year. Nine of these are new contracts; the first new contract this year was with North Carolina. Four of the contracts are renewals from the pilot program that started last year. The agency is also negotiating with 21 more states. We hope to have all of the states involved by the end of the year.

A national, FDA-funded tobacco education and advertising campaign is getting underway in 10 states. It will be expanding to more states as they become part of the compliance program. The president has proposed a $100 million addition to the funding for next year’s tobacco program to permit us to expand the compliance and education programs at the state level. The successful initiation of the tobacco program so far is a good example of how effectively FDA can work with the states when funds are available.

One of FDA's future challenges is the growing workload. Applications are up 12 percent over each of the last four years. At the current rate, the workload is doubling every six years. The steady rise in research and development investments by both the National Institutes of Health and the pharmaceutical and device industries ensures that there will be more and more products in the approval pipeline. Imports, too, have more that doubled this decade to more than 4 million entries per year.

Fortunately, through reinvention and streamlined management, FDA's performance has managed to keep up. The agency responded with a 17 percent rise in approvals for all categories of products it reviews over the same period as the rise in workload. The agency has been approving twice the number of New Molecular Entities or NMEs in half the time.

But FDA can not maintain this pace forever. Even though some programs, like pre-market review of drugs and biologics and now the food safety programs, have received additional resources in recent years, FDA's budget has been essentially flat at a 1.3 percent rise over the last four years.

In addition to the concerns about resources, FDA worries that as the science continues to advance, the agency will have a difficult time staying on the cutting edge. FDA is working hard to form alliances and relationships throughout the scientific community, including government, academia and industry. The agency is making major commitments to continuing to develop its scientific base in both the laboratory and the clinic. In addition, FDA is currently searching for a new chief scientist to run FDA’s Office of Science.

There are also many international changes underway that will have profound impacts on both FDA and the states. FDA is seeing more products coming into the country and not just active ingredients but finished products.

For food safety especially, this is going to require increased efforts by FDA and other federal agencies, as well as the states, to ensure the safety of the nation’s food supply. The rising international tide, however, is not restricted to foods. Every product in FDA’s inventory is increasingly becoming internationalized. But it's also important to know that the agency will not be lowering its standards through international agreements. This is something FDA has been saying all along, so I was pleased to hear the President affirm that concept recently.

Lastly, let me talk a little about the FDA Modernization Act of 1997. Congress passed a major piece of legislation that substantially added to FDA's workload. I'm not going to detail all the changes contained in the act, but suffice it to say that they touch nearly every activity that FDA conducts. And with FDAMA, the agency certainly understands what it means to have new additional work without additional resources to do it. But we have worked hard and the agency is on target for nearly all of the required actions and certainly is in compliance with the spirit of the legislation.

As part of the FDAMA tasks, we are undertaking several analyses of FDA’s activities and our relationship with organizations like AFDO and the states. Congress has directed us to evaluate our statutory responsibilities, identify gaps that exist, and consult with stakeholders as to how to eliminate such gaps.

As part of that process, we will be talking to groups like AFDO to have them help us set priorities about any responsibilities we need to adjust. The results of this analysis will be published in the Federal Register in November.

This engagement with stakeholders in not new for FDA. We do it because it is good government. We are an institution that serves the public and organizations like AFDO who are part of that public, though AFDO is a more sophisticated part. So that makes your input valuable to the agency. We are still establishing the process for formal input into this process, but it will be available soon.

There are several areas we already have focused on as needing special attention. These include three major areas, post market surveillance and adverse event reporting; compliance issues such as inspection for good manufacturing practices; and premarket review and approval for non-user fee areas. The agency will also be looking at a range of activities from partnerships to education, research infrastructure to information systems.

In conclusion, this is a wonderfully challenging time for FDA. It is a time of tremendous promise and opportunity. To capitalize on this we must work together to make important contributions to the public health. That is our common goal. The states and AFDO’s members have been instrumental in keeping the public safe. I look forward to being able to work together to make sure the public remains safe in the years to come.