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Jane E. Henney, M.D. - NONPRESCRIPTION DRUG MANUFACTURERS ASSOCIATION

"This text contains Dr. Henney's prepared remarks. It should be used with the understanding that some of the material may have been added or deleted during actual deliver."

Remarks by:

Jane E. Henney, M.D.

Commissioner of Food and Drugs

 

NONPRESCRIPTION DRUG MANUFACTURERS ASSOCIATION

BOCA RATON, FLORIDA

MARCH 12, 1999

Good Morning. It is truly a pleasure to be here to speak to you as Commissioner of Food and Drugs. I would like to take a moment to sincerely thank you for your support during my confirmation process. I was very touched by the countless letters and words of encouragement that I received. I know that your organization was one of the first to come out publicly in support of my nomination, and I am very grateful for that.

I have found my first few months at the Agency to be extremely busy, exciting and challenging. I am constantly reminded of the very important work that we do every day, with the help of organizations such as yours. Though at times the amount of work seems overwhelming, I am comforted by the words of Abraham Lincoln, "The best thing about the future is that is comes one day at a time."

But, while I am just entering as Commissioner, Jim Cope decides that this is his time to leave—is there a message that I’m missing?? And, after that very modest summary of Jim’s accomplishments that you have just witnessed, I would like to mention that I am very sad to see him step down from the leadership of your organization. I have known Jim for years, and have the highest of respect for him. I admire both his personal integrity and his strong commitment to the public health.

One thing that is particularly remarkable about Jim is his ability to forge consensus on difficult issues. It has been my experience that Jim always tells me the truth. He is a straight-shooter, even when the message isn’t a pleasant one to deliver. From the 1962 Amendments to the OTC review to tamper-evident packaging--Jim has been involved in all of the major issues affecting your industry. I know that everyone in this room agrees that Jim leaves very large footsteps to fill—both literally and figuratively.

As you all know by now, we had an important announcement yesterday. Vice President Gore unveiled FDA’s new OTC drug labeling initiative, a final regulation that will vastly improve the presentation of information received by patients and consumers regarding the over-the-counter products that they purchase and give to their families.

This final rule, which will be published in the Federal Register next week, calls for a standardized format that will improve the labeling on all OTC drugs Americans use. By clearly showing a drug’s ingredients, uses, warnings, and directions organized in a clear, logical way, the new labeling will make it easier for patients and consumers to understand information about a drug’s benefits and risks, as well as its proper use.

This initiative is analogous to the labeling regulations for foods that were promulgated under the Nutrition Labeling and Education Act of 1990. We are hopeful that the new OTC label will be as widely recognized and openly praised as the nutrition label. Just as the nutrition label has helped millions of Americans make healthy choices about the food they eat, the new OTC drug label will help people make more informed decisions about the over the counter medicines they take.

I know that many of you here today have been heavily involved in this initiative for years. From the label readability guidelines that your organization developed in 1990 to your comments on the regulation we proposed in February 1997, you have been a critical part of the development of this rule. I am well aware that much of the fundamental thinking involved in the regulations announced this week came from ideas developed by some of you.

In particular, your comments on our proposed rule, as part of the nearly 2,000 that the Agency received, were integral in the development of labeling requirements that will improve the presentation of important information to consumers on OTC drug labels in a manner that is feasible for manufacturers. I know that your organization and the Agency have not always agreed on every component of this regulation. However, I am confident that through our discussions, we have reached a common ground on which we all will be proud to stand. We have developed a rule that takes into account the needs of the wide variety of marketed OTC drug products, and I believe that it will be quite rare for a product to be unable to comply, given the flexibility allowed in this regulation. For particularly difficult cases, we will work with manufacturers to resolve those issues.

I would like to briefly outline some key elements of the regulation. The rule has been developed so that all OTC drugs have labeling that is easy to read and understand. It is our hope that the new format will also enable consumers to more easily select the most appropriate OTC medication and understand its benefits and risks. The new labeling will make it easier for consumers to identify active ingredients and their purposes, which will be listed at the top, followed by uses, warnings, directions, and other information.

The new format will have standardized headings and subheadings using terms that will be more familiar to consumers. It will also require that information appear in a standardized order. And, there are certain specifications for graphics on the label, including requirements for type size, justification, bold lettering, bullets, tables, contrast, and white space…very critical factors when you begin to reach my age! The regulation also implements the FDAMA statutory requirement for listing inactive ingredients that will allow consumers to identify products that contain ingredients to which they are allergic.

We anticipate that OTC drugs bearing the new labeling will begin appearing on the shelves in the near future and that all OTC drugs will adopt the new labeling within the next six years.

I would like to mention another issue that may be of particular interest to this group. In October of 1998, the Agency issued a final regulation requiring that all over-the-counter drug products for adult use containing analgesic/antipyretic active ingredients bear alcohol warnings on their labels. When the Agency issued this regulation, comments were received from several large manufacturers of these products stating that the Agency did not provide adequate time for them to come into compliance.

These comments asserted that relabeling procedures generally take more than the 6 months allotted, and that this timeframe does not promote an emphasis on labeling integrity and good manufacturing practice compliance. Based on new information that we have received, it appeared that the Agency may have underestimated the number of individual label changes that some manufacturers will have to make, or may have underestimated the impact of these changes on manufacturers.

Therefore, we held a public feedback meeting on this issue to hear comments regarding the compliance date. We consider the inclusion of alcohol warnings on these products to be a significant public health protection. We therefore have carefully reviewed and considered these comments and the additional information received after the rule’s publication. The Agency agrees that the original 6 month implementation period would not provide adequate time for many manufacturers to relabel a significant number of their products.

Therefore, I would like to announce today that we have decided to extend the compliance date for this regulation an additional 6 months, or until October 22, 1999. We hope that this decision will alleviate some of the concerns raised by some manufacturers about the feasibility of their compliance by the original deadline.

In addition to these OTC drug-related issues, I would like to take a few moments to discuss my priorities for the Agency during my tenure as Commissioner.

As I have mentioned in other settings, my priorities for the Agency are: the full and complete implementation of the Food and Drug Administration Modernization Act of 1997, in accordance with both the letter and spirit of the law; the enhancement of the Agency’s scientific base; and the development of the Administration’s initiatives on food safety, blood safety and tobacco.

Let me expand on a few of these areas. First, the FDA Modernization Act. Over the past year or so, FDA has been working diligently on implementing the new statute within the timeframes set forth in the FDA Modernization Act.

The Agency has done such an unprecedented amount of work within one year’s time to implement a statute. Countless statutory obligations and deadlines have been met, dozens of guidance documents and regulations issued, and many other tasks mandated by the statute have been completed. Let me give just one example of these "other" tasks.

Section 406(b) of the Modernization Act required the Agency to solicit information from the outside world as to how we can do a better job of meeting our statutory obligations. Taking this directive from Congress very seriously, members of the Agency’s senior staff have spent a significant amount of time at public "stakeholder" meetings around the country. These opportunities allowed those outside the Agency to provide their insight and expertise on how FDA can do a better job. I have found these sessions to be invaluable.

We plan to hold another series of stakeholder meetings this spring. I look forward to hearing from organizations such as yours about additional improvements that we could make as an Agency.

Let me also expand on this issue of strengthening the science base of the Agency, as it is the second on my list of top priority areas for the Agency. I want to ensure that science underpins all of our decision-making. From the reviewer to the inspector, we can only be effective if we have a strong, scientifically-skilled workforce.

Since we must sit in review of new products that are the result of cutting-edge science, our judgments will only be as strong as our scientific expertise. It is imperative that we have the mechanisms and resources available to see that we maintain a presence in the world of science. We need means of retaining our best scientists as well as mechanisms for leveraging the intellectual power, and talent, of other science-based governmental agencies and academia. We cannot allow our staff to become stagnant. If we do not focus our time and energy on this area, the effects of our failure to do so could have a devastating effect on public health…our decisions will become risk averse—slow—or wrong.

One area that NDMA cares about a great deal is Rx/OTC switches. The approval of switches involves very complex scientific decision-making. This is an excellent example of an area where the Agency needs to be confident that its decisions are based in the most recent scientific information available.

The third area—and it is a vital one—is assuring the safety of the nation’s food supply. Food safety is truly at the core of our mission at the Agency. Again, we are working together with our partners in government to enhance the science that underpins all our food safety activities. This includes not only research and development, but prevention and education efforts and enforcement to ensure that the nation’s food supply is as safe as possible.

The fourth priority is the safety of the nation’s blood supply, and the last is tobacco. These last three areas—food safety, the safety of the blood supply, and tobacco—are not only priority areas for the Agency, but the Administration as well.

Let me just spend a few moments talking about the Agency’s performance with respect to its review of new drugs, biologics, and diagnostics. FDA’s mission is to protect the public health by doing its best to ensure that the products it regulates are safe and effective. However, product reviews must be efficient. FDA is not fully promoting the public health if it does not make timely decisions on applications to market products such as new prescription drugs and devices. The product review record of the FDA in 1998 demonstrates the Agency’s exceptional performance. The 1998 approvals include a high number of products that represent significant advances over the products that were previously available.

And, the importance of the improvements to FDA’s review programs goes beyond the numbers. For instance, exciting new therapies in a wide range of areas that were brought to market in the past year include: several new treatments for breast and bladder cancer, a better tool for analyzing mammograms, new arthritis drugs, new AIDS therapies for both adults and children, and a diagnostic tool for osteoporosis.

New drugs are now being reviewed as fast or faster than anywhere in the world, without compromising the very stringent standards that Americans have come to expect.

As you know, new over-the-counter drugs, including Rx/OTC switches, are also reviewed under the same timeframes as that of new prescription drugs. In the past year alone, we have approved 15 new drugs or new uses for OTC marketing, in addition to the abbreviated new drug applications. Over the last five years, there has been a dramatic increase in the number of OTC switches approved.

While our priorities have been made clear and our performance in many areas is very strong, we have great gaps between what Congress and the public expects us to do as spelled out by statutory mandates, and what we are able to accomplish with our resources. The Agency has undertaken a "gap analysis" and has discussed this issue at the stakeholder meetings I mentioned earlier. We then used this information from both of these exercises to construct the budget for fiscal year 2000.

Earlier this year, the White House sent that proposed budget to Capitol Hill. If funded, it will provide a very welcome $216 million increase. Although this is a nearly 18% increase over last year, it is only a down payment on FDA's budget needs. I was dismayed to find that the base budget in certain critical areas was lower than it was when I left.

If not corrected, it will weaken our ability to do the work and provide the protection and service that consumers and patients have come to expect.

This erosion of the financial base of the Agency has had a devastating effect on some of our fundamental programs. Our funding has remained relatively stagnant with the only new money, mainly provided through user fees and the food safety initiative, earmarked for specific programs. Yet, with the growth of technology, FDA’s responsibilities are becoming increasingly great and increasingly complex.

These are the Agency’s priorities, and a snapshot of the performance in those areas. When we undertake things outside of these priority areas, it needs to be because of a pressing public health demand. We like to think of ourselves as a "can do" Agency, but it is clear that within our available resources we can’t do everything. We can act no longer simply out of good intentions, lest we spread ourselves too thin to be effective at anything.

I know that many of your member companies are moving into the area of dietary supplements and herbal products. Our goal this year is to complete the development of an overall strategy for effectively regulating dietary supplements consistent with the Dietary Supplement Health and Education Act of 1994. This effort will be led by The Center for Food Safety and Applied Nutrition, under Joe Levitt’s direction.

For this strategy, some areas where we intend to put our energy are: development of good manufacturing practices for dietary supplements, which was one of my stated commitments during my confirmation process; improvement of current adverse event reporting, review, and follow-up; analysis of enforcement priorities for the Agency in the supplement area; delineation of what constitutes an appropriate claim on a dietary supplement product; and definition of boundaries between various types of products, including: dietary supplements, conventional foods, drugs, and cosmetics. The industry and the Agency are going through much of the same growing pains that the OTC industry did a few years back. We have many lessons to learn from that experience. It is important that we construct a framework and action plan that meets Agency, industry and public health needs.

I know that members of your organization who are active in this area have been in communication with us regarding some of these issues. I look forward to a continued dialogue with you in this area as we move forward on making policy decisions in this very complex and important area.

In conclusion, I look forward to the future of the Agency, and to working with associations such as yours in it. You have my firm commitment that I will put a great deal of energy into ensuring that the Agency focuses on its priority areas. I also intend to work diligently to see that the Agency’s science and research infrastructure be as strong as possible. We owe it to the American people to have their Food and Drug Administration be as strong and effective as possible in protecting and promoting the public health. Thank you again for inviting me to be here today, and thank you for listening.