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Jane E. Henney, Ph.D - Utah Life Sciences Association

"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

Utah Life Sciences Association
FDA and the U.S. Leadership

Salt Lake City, Utah
September 11, 2000

Good morning. It's a pleasure to join you here today.

Let me begin by saying a few words about FDA. I'm sure most of you are quite familiar with FDA's role, or at least the role that pertains to your own area. What many people frequently don't realize is the breadth and diversity of products that FDA regulates. The agency is responsible for an immense range of products, including foods and food additives, cosmetics, veterinary drugs and feeds, vaccines, the nation's blood supply and medical drugs and devices from the simple to the very complex.

Although we are well resourced with a wealth of issues and interesting questions, FDA conducts its business on behalf of the public with very limited resources, a little over a penny a day per person. It does this by first attending to those issues that pose the greatest risk, while also maintaining the agility to meet the unexpected challenges that arise. As stewards of the public's funds, it is important that we be prudent. At the same time, given the breadth of our responsibility and the expectations of the American people, it's important to realize that our current level of funding restricts the degree to which we can meet an expectation to do it all with the same level of intensity and effort.

You've asked me to touch on a wide array of issues, but like all resources I want to use my time with you wisely, so I've selected those that seem to be of the highest priority to you and the agency.

Let's start with the Food and Drug Modernization Act of 1997, or "FDAMA," which many of you are familiar with. As you may know, I made the implementation of FDAMA one of the agency's highest priorities when I was selected to be Commissioner. There are three parts of FDAMA that have reinforced how FDA conducts it business. The first is the emphasis placed on using the best science to support our decisions. This is not a new concept; it's an FDA tradition. Today science and technology are moving forward in leaps and bounds. With every new discovery, our learning curve gets a bit steeper. The amount of new information being generated in nearly every area the agency regulates is staggering and the science is becoming complex. FDAMA recognizes this, and supports our ongoing efforts to strengthen the science and analytical base for making regulatory decisions. This, too, has been a high priority for the agency.

Secondly, FDAMA gave us renewed impetus to seek regular input from the many who are affected by our actions, including consumers, patients, health professionals and the regulated industry, on how we can best accomplish the goals of FDAMA. One of the ways we're doing this is with a series of "stakeholder meetings." The first meetings were held in 1998 and several have been conducted since. These meetings have addressed general themes such as FDA's implementation of FDAMA, and the agency's "gap analysis," which compares our current mandated responsibilities with what we are able to accomplish given our resource limitations. Another topic has been leveraging-an initiative to collaborate with other organizations to accomplish work that is of mutual interest and benefit. We'll hold a stakeholder meeting this Friday, to examine the Prescription Drug User Fee Act, as we prepare for its reauthorization. These meetings are designed to provide interaction and discussion, and listening on the part of FDA, with our constituents in the diverse areas under our jurisdiction.

Third, FDAMA underscored support for the agency in assuring that our decision-making processes remain open and transparent to the public. We regularly seek advice and feedback on our decisions from the public on topics ranging from foods using the tools of modern biotechnology, to the use of dietary supplements in women of child-bearing age, to the issue of financial conflict of interest involved in clinical trials. We take advantage of the expertise of our colleagues in the scientific community through our advisory committee process. We now make available on our web site the decisions related to product review, research findings and enforcement actions.

As the FDA commissioner, I am frequently asked...what is the biggest challenge for the agency? It seems to me that FDA's greatest challenge lies in maintaining scientific strength. The public's trust and confidence in FDA are tightly linked to our ability to make decisions that are independent, objective and grounded in science.

FDA has earned the trust of those it serves. An April survey of federal regulatory agencies, conducted by the Pew Charitable Trust, asked the medical profession, patient advocates, the chronically ill, and those business regulatory officers whom we interact with, their opinions about the FDA and its decision-making.

First and foremost, these highly varied groups have confidence in the agency. Seventy-two to eighty-five percent of these groups trust FDA to make the right decisions, and seventy-four to eighty-seven believe that FDA uses good science in its decision-making. The message is simple and it came across loud and clear. Trust and confidence are earned by relying on science, not whim. Good science. To do this we must have in-house medical officers and scientists, as well as access to others external to the agency so that we have the latest and best scientific thinking. It's essential for the agency to have the expertise to adequately assess the safety and effectiveness of new products and technologies before they reach the marketplace. Without these things we cannot be prepared, or depended upon, to make the right decisions in a timely manner.

FDA's need for scientific expertise extends well beyond the review component for new products. Field investigators and policy makers must also have their actions grounded in science as well as the law that serve as compass points for agency action.

Combining science and law...or science and regulation...is a unique challenge and requires specialized training. FDA addresses these training challenges in a number of ways, and we've begun several initiatives to bring additional training and continuing education to our staff.

I might add that training is an area where we have been very successful in leveraging resources. You may have heard me say...because I've stressed this repeatedly...that one of the most important initiatives at FDA is leveraging. By that I mean investing our resources in collaboration with others to help us get the job done faster and with expertise we may not have in-house. By pooling our financial and intellectual assets we're able to achieve results greater than either organization could have achieved alone.

We've begun an exciting aspect of training that is a wonderful example of how leveraging can be of mutual benefit to the FDA and to our colleagues in the scientific community. This is our series of joint FDA/Industry training courses. A year ago, we began a series of courses that are sponsored jointly with industry, and focus on new technologies. Our objective is to bring scientific information about new technologies to the FDA and provide a forum for FDA field investigators, FDA headquarter scientists, and industry to come together to discuss new technologies, and share perspectives, in an informal setting. I'll give you a few examples of the courses we've held so far. One was on barrier isolation technology with Merck. Another was on ELISA rapid screening methods with the Grocery Manufacturers of America and General Mills, and yet another was on microarray technology with the Bay Area Bioscience Center and a number of California biotechnology companies. For the upcoming year we're organizing courses on new trends in sterilization with Johnson and Johnson, and nucleic acid amplification testing.

We have several other topics in mind, but we're open to suggestions for new course topics.

Let me turn to some of the specific topics I know are on your minds.

The first concerns the reuse of medical devices that are intended for single, or one-time, use. This has been a not just been a matter of quiet debate by different factions of the industry, but a subject that has make its way to the press and congressional hearings. The FDA and its Center for Radiological Health have issued a final guidance on the practice of using medical devices intended for single use. Under the final guidance, FDA will regulate third-party processors and hospitals that reprocess single use devices the same way the agency now regulates original equipment manufacturers. FDA has established enforcement priorities for the premarket submission requirements based on the existing medical device classification. Let me explain. FDA intends to actively enforce the premarket submission requirements for third party and hospital reprocessors for class III devices. The next priority is class II devices, and lowest priority is class I medical devices.

Detailed information on the reuse of single use devices is available on CDRH's web site. For those of you who are interested, the FDA and the Association for the Advancement of Medical Instruments will be having a joint public meeting on "Reprocessing of Single Use Devices: New FDA Regulations for Hospitals," on October 30, in Rockville, Maryland.

Third-party review of medical devices is another area that warrants some discussion. The medical device industry asked us for this option; FDAMA gave us the authority to establish this process, and FDA put the process in place. The process has worked for those devices that have gone through it. But very few have been submitted. There are now 211 device types that are eligible for third party review; most of these are class II devices. That means that approximately 1500 510(k)s per year could go through this type of review. Interestingly, only 32 were submitted to third parties in fiscal year 1999. The question is... why aren't more device applications being submitted for third party review? We've heard several reasons. One is that the reviews are being done so quickly by FDA's Center for Devices and Radiological Health, that companies are saying, "FDA will review my application for free, so why should I pay a third party to do it?" Another factor is that companies generally get to know the reviewers at FDA that are the experts with their particular types of devices. They know the FDA review will be consistent and predictable, and they're not particularly interested in getting to know a third party reviewer.

Our concern is that as long as FDA continues to review all these applications, we're limited in our ability to use our human as well as fiscal resources in areas of highest need. We're proposing a further expansion...more on that during the panel discussion.

Before I leave devices, I'd like to mention one program that may be of interest to you or your colleagues. The Division of Small Manufacturers Assistance--in the Center for Devices and Radiological Health. This division gives frequent seminars on how to create an application for approval, sends out publications to device manufacturers, writes guidance documents, answers questions and is the international point of contact for foreign manufacturers. For those in the audience who need their assistance, they can be reached at www.fda.gov/cdrh/devadvice.

Turning now to drugs... The funds provided by industry as a result of the Prescription Drug User Fee Act have enabled us to hire reviewers, rebuild our infrastructure and systems, and speed up review times. Up until the mid-1990's, the agency had been criticized for delaying the availability of medical therapies to patients. This is clearly no longer the case. With additional funding provided through the Prescription Drug User Fee program FDA has proven that when adequately funded it can meet extremely demanding performance goals. We are now reviewing drugs in the U.S. as fast or faster than anywhere else in the world, without compromising the very stringent standards that Americans and the rest of the world have come to expect. The average review time for drugs is less than 12 months and for drugs for serious and life-threatening conditions less than 6 months. This is occurring in spite of the increasing number and complexity of products reviewed today.

What has this meant? For patients it's meant more therapies sooner. For the industry it's meant timeliness and predictability on the part of FDA, and a greater return on investment, with a savings of nearly 2 billion dollars a year. To FDA the program has meant additional resources to do our job, and an improvement in the quality of applications submitted. And what has it meant for our country? A credible, high-performing agency enhances U.S. competitiveness in global markets and strengthens the domestic economy as a whole by inviting increased foreign investment in this country.

There are three areas of concern with this PDUFA "experiment." One is that while we have additional resources in some areas, other areas are suffering from a lack of resources-areas such as generic drugs, and over-the-counter products where completing the monograph series is critical. The second problem involves those areas that are underfunded in the post-market arena, such as adverse event reporting. The agency's own report on managing risk, as well as the recent IOM report on medical errors, spoke to the need for better monitoring, better research and better labeling of products, in order to appropriately manage risk.

Another concern related to PDUFA is the perception that having funding for premarket drug review provided from the regulated industry has diminished the agency's independence and objectivity. We have no evidence of this, but even the perception, if perpetuated, diminishes our effectiveness. As I mentioned earlier, we're hosting a public meeting this Friday, in Washington, to talk about and get feedback on this and other issues related to PDUFA. This will be a particularly important meeting because PDUFA will be expiring in 2002. We'd like to see PDUFA reauthorized in a way that is of the most benefit to all concerned, and provides the most protection to public health.

Before I leave the subject of drugs and drug approval, I'd like to briefly mention a topic of timeless importance-the protection of human subjects in research. As a result of recent tragedies, including the death of Jesse Gelsinger, it's timely to remind ourselves once again that close attention must be paid to the subjects' best interests when they agree to participate in a clinical trial.

What have been the issues in this case and others that we have recently investigated? Sadly, some of the most basic elements of what it takes to properly conduct clinical trials were not followed. For example, patients enrolled who didn't meet eligibility criteria. Adverse events not reported as required. Protocols not followed, or changed without proper notice to the IRB and to FDA. Study staff not adequately trained. Informed consent forms not revised as requested by FDA. Inadequate record-keeping. Financial conflict of interest issues not addressed.

I raise this because any erosion of our system for safeguarding human subjects is troublesome for many reasons-first and foremost, the direct harm to patients. But...the reputations of investigators, the academic institutions, the research community as a whole, and the entire enterprise of medical innovation are threatened when public trust and confidence are lost.

These are the problems, and collectively we must all work on the solutions.

The system involves shared responsibility-shared between the industry, institutions and IRBs, clinical investigators, and government regulators. We at FDA have implemented Good Clinical Practices in the U.S. through regulations and guidance, and have enforced these practices both in our review process as well as in our on-site inspection program. If clinical investigators and their institutions are not extremely familiar with and following these Good Clinical Practices, they certainly need to be.

Before I close, I'd like to share my perspective on today's global marketplace and product regulation. Our world is shrinking. None of the topics I've covered today are limited to this country. Medical product development and food production and processing are truly global operations. The science becomes ever more complex and so do the regulations and standards that we're guided by. Let's look at some examples of how we are doing. Harmonizing our requirements, our standards, and our application and approval processes is a worthy goal--one that we've been devoted to for over a decade.

As you know, the success of the pharmaceutical industry depends on its ability to compete effectively and respond quickly on a worldwide basis. Through the International Conferences on Harmonization, or ICH, process, the U.S., Canada, Europe, and Japan are leading the effort to streamline the drug approval process and create a level playing field across our countries' borders. For the past ten years, our focus has been on harmonizing technical requirements on specific issues such as chemistry standards, pharmacology and toxicity testing. We now have 50-60 agreed upon guidelines addressing very specific topics.

Our next area of focus is on developing a common technical document to standardize marketing applications in these countries. We envision a core international document that will include all study reports, clinical studies, and pharmacology and toxicology information. By having such a core document, industries in participating countries will be able to submit the same document in every country, with local appendices to meet local requirements.

We're also working on harmonizing the submission of postmarket data. The periodic safety report will be a common core document allowing a company to create one report and submit it to all participating countries, again with certain local appendices.

There's been a great deal of effort and activity internationally in the medical device area as well. We currently have a mutual recognition agreement with the European Union such that we recognize each other's inspection of medical device manufacturers. The agreement also allows the E.U. to do certain 510(k) reviews. In addition, we've agreed to share post-marketing data--information on problems with devices. We are also part of a Global Harmonization Task Force, along with the E.U., Japan, Canada and Australia, which is devoted to promoting harmonization among these five groups in the way they regulate medical devices.

It's important to keep in mind that having an aggressive trade policy means we must be in the position of setting the standards, scientifically equipped to handle disputes when they arise, and able to meet requirements set by trade agreements as they relate to equivalency.

I've covered a range of topics today. These are just a few of the challenges the agency is facing. I'd like to close by saying that it's an exciting time to be at the FDA. Science continues to broaden our horizons, bringing us possibilities beyond our imagination ten or twenty years ago, and we'll continue using the best science to ground our decisions.

I look forward to the panel discussion and I'll be happy to answer your questions then.