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Lester M. Crawford, Jr., D.V.M., Ph.D. - Soap and Detergent Association

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

The Soap and Detergent Association
Remarks by
Lester M. Crawford, Jr., D.V.M., Ph.D.

Deputy Commissioner
U.S. Food and Drug Administration,
October 2, 2002

Thank you for the introduction, and good afternoon. Since February, when I rejoined -- for the fourth time -- the Food and Drug Administration, I've been frequently asked to discuss with FDA stakeholders a variety of public health matters that our agency deals with, and that are of interest to the regulated industries.

Your association was the first group that asked me to address a single issue -- a Tentative Final Monograph, or TFM, for Healthcare Antiseptic Drug Products -- and to be perfectly honest, my first reaction to the request was not enthusiastic. But after I've done some research I can see why this subject is of such intense interest, and I am here to tell you that I am glad you've asked me to discuss it.

The monograph issue is important to your industry as well as to the public whose health our agency is mandated to promote and protect; and discussing it gives me an opportunity to explain something about the FDA that's pertinent to our subject and, I hope, will help you appreciate the FDA's actions and policies.

The TFM issue goes back to 1972, when the FDA began to review marketed OTC drugs used as healthcare antiseptics -- that's 30 years ago, or, to put in perspective, the year when President Nixon went to China to meet Chairman Mao; Washington police caught five men bugging telephones in Watergate, and the first floppy disks and microprocessors ushered in the age of personal computer.

Since then, the monograph has traveled a long and sometimes difficult road that in the FDA records is marked by several milestones:

In 1974, our agency published the recommendations of its advisory panel on over-the-counter antimicrobial drug products. Among other findings the panel concluded that hexachlorophene, which was then used in 1,500 OTC products, was toxic to the central nervous system. The panel also identified triclosan as one of the ingredients of antimicrobial products that lacked sufficient evidence of safety and effectiveness.

In 1978, the FDA issued a proposal that, among other provisions, requested more data on long-range safety and effectiveness of triclosan. And in 1991, the FDA published a proposal in which the agency determined that antimicrobial soaps should no longer be evaluated as a separate drug product category.

The proposal also stated that a soap that made an antimicrobial claim was subject to regulation as a drug. As a result, antimicrobial soaps for consumer use appeared to have been excluded from the OTC review. This was the root of a controversy that emerged in full force in 1994, when another FDA proposal indicated that antiseptic handwashes for consumers were expected to demonstrate the same level of effectiveness as products for professional use. The same proposal requested additional information to support the safety and effectiveness of triclosan.

You're familiar, I am sure, with the main developments since that proposal was made. Your association, together with the Cosmetics, Toiletries, and Fragrance Association proposed a monograph that revised the criteria for testing and effectiveness to reflect the estimated health impact of each class of drug products.

While that discussion went on, an FDA advisory committee in 1997 recommended that the agency and manufacturers create a surveillance system that would keep an eye on the possible emergence of antimicrobial resistance connected with the use of healthcare OTC antiseptics.

And finally, two years ago, the American Medical Association -- which believes that triclosan is capable of causing antimicrobial resistance -- requested that FDA expedite its regulation of such ingredients in consumer products.

And so here we are today, two generations after the issue was born, and we still haven't reached agreement on what should be in the Final Monograph. The FDA still is looking for data on the long-term health effects of triclosan, and at present there is no joint effort to trace the effect, if any, of antiseptic products on antimicrobial resistance. Your industry does not have the benefits of the legal backing it would derive from an FDA monograph. And worst of all, consumers and health care professionals are not as fully protected as they deserve, expect, and have the right to be.

This is a situation none of us want, and considering the longevity of this issue -- after antacids, this is the second oldest unfinished OTC drug review on our agenda -- I believe it's time for all of us to ask some basic questions: specifically, what's at the core of our positions that has made this monograph so resistant to resolution?

And because I have raised the question, I will try to answer it for the FDA, by explaining what makes our agency tick: why the FDA has been so firm on the this issue -- and how we can work together to put it, at long last, to rest.

There are two dimensions to the FDA that I need to describe to give you a meaningful picture of our agency. One of them is the size and complexity of the FDA universe, which sets the limits for the amount of resources we can devote to any issue.

We regulate some of the world's largest and most prolific industries that operate more than 120,000 establishments, both in the United States and abroad. These firms manufacture, import, transport, warehouse, and distribute a vast variety of products -- almost one-and-a-half trillion dollars worth of them a year -- that include 80 percent of the nation's food supply -- everything we eat except for meat and poultry -- all human and animal drugs; all human biological and blood products; all tissues for transplantation; all medical devices; all equipment that emits radiation; all animal feed, and all cosmetics.

This vast supply of goods is essential to keep 285 million Americans, and millions of other consumers abroad, alive, healthy, (and, as you well know) well groomed and clean -- and our agency is responsible for making sure that all of the products I mentioned are safe, or safe and effective.

Now, as rational individuals, you may well be asking, "how on earth this enormous collection of very difficult, disparate, and frequently life-and-death issues, wound up under one roof?" Actually, the issues are not under one roof, although the proverbial buck does stop at one desk, which right now happens to be in my office.

We have a separate line organization, called a Center, for each drugs, biologics, medical devices and radiological products, veterinary products, and food -- and food is the only hybrid Center because it also regulates cosmetics. These centers set the standards for the regulated products, and our field staff of inspectors and other specialists -- who are based in 150 offices and laboratories from coast to coast and Puerto Rico -- make sure that the standards and complied with.

We also have a center that does our toxicologic research, and we get considerable scientific support from institutes that the FDA operates jointly with industry and academia. Until last year, we had about 9,000 employees and a budget of a little over $1 billion to do all the work, but since the attack last September, the FDA has found itself on the front lines of homeland security, and our budget and staff have gone up.

That still does not answer the question how FDA has come to wear so many hats; and while the obvious explanation is that such has been the will of the United States Congress, the reality is not that simple. The real story is that over the years, the FDA has grown organically, in response to genuine needs.

And that brings me to the other FDA dimension, one that is much less well known than our statistics, and that bears directly on FDA's attitudes and institutional culture -- in short, on what makes the FDA tick.

Today's FDA is the sum of developments that go back for 96 years, and I'll try to illustrate the process by describing the landmarks:

The FDA got its start in 1906, when a journalist named Upton Sinclair published a book you probably know -- it's called "The Jungle." It was a carefully researched portrait of the terribly unhygienic conditions then prevailing in the Chicago stockyards, and it caused an enormous public outcry that was followed by a 30 percent drop in meat consumption and an official probe that bore out Sinclair's charges.

In response, Congress passed the Food and Drug Act that outlawed adulterated food, drugs and drinks in interstate commerce, and directed the Agriculture department's Bureau of Chemistry to ensure compliance.

The Bureau was subsequently enlarged and reorganized as the Food and Drug Administration, but the Food and Drug Act was so ineffective and full of holes that in 1937, a perfectly legally manufactured, but virulently toxic, elixir of sulfanilamide killed 107 people, most of whom were children.

There was another huge popular outcry, and the following year Congress passed the Food, Drug and Cosmetic Act that completely overhauled the public health legislation. This law, which is still the FDA's basic statue, multiplied many fold the agency's responsibilities and powers, and launched a new system of drug regulation, by requiring that drugs be shown to be safe before marketing.

The new act seemed to be working well until 1962, when only the vigilance of the FDA's Dr. Frances Kelsey -- who, incidentally, still works for our agency -- saved American pregnant women from exposure to thalidomide, a sedative that had caused horrible deformities in thousands of babies in Europe and South America.

That event sent another shock through the public health system, and Congress responded by passing the Kefauver-Harrison Amendment that among other provisions tightened the drug safety provision of the 1938 law; introduced FDA inspections for good manufacturing practices; and added the requirement of drug effectiveness as a condition for approval.

There is one more public health upheaval that I have to mention. This one took place in 1976, and was triggered by a Senate committee report showing that in ten years, faulty medical devices had caused 10,000 injuries, 731 of which were fatal. Faulty IUDs accounted for 8,000 injuries, and 512 of the deaths were attributed to poorly functioning heart valves.

Rather understandably, Congress again responded by legislating. This time, it added to FDA's mission the ensurance of safety and effectiveness of three classes of medical devices.

These were only the major events behind our huge agenda. In addition, there have been so many less dramatic public health developments and congressional responses that by now, the 1938 act has more than 200 amendments, most of which have added to our workload.

Collectively, this historic record accounts for our agency's two basic characteristics, which are vigilance and reliance on science. If a substance can be harmful to the public health, our agency has learned over the last 96 years, it will cause harm. Therefore, we have to design and rigorously implement appropriate science-based measures to prevent that from happening.

This is the bedrock of the FDA culture, as well as the tenor of most of the laws whose enforcement is our job. But there is one more legislative landmark that I have to add to this list. Like the other laws I've mentioned, this one involves a key FDA learning experience; but unlike the other laws, it was not brought about by a tragedy, but by a major public health success.

The law I am talking about -- the FDA Modernization Act of 1997, or FDAMA, as we call it -- for the most part sanctioned the FDA's pioneering efforts in the more recent years to find a new way to protect the public health. That new way, which has been tested and frequently found to work well, is cooperation.

This is a development that has many roots, the most significant of which have been the mushrooming globalization of production, consumption and trade that set in after World War II. With imported food, drugs, devices and other regulated products arriving at our ports of entry at rates that increased up to 15 percent a year, the FDA had to find a new system for ensuring that this vast amount of goods complied with the United States standards.

One obvious approach was to have FDA scientists and engineers help various organizations of the United Nations develop international product standards that would provide the same level of public health protection as our criteria. The big lesson of this cooperation in the CODEX Alimentarius Commission, International Organization for Standards and similar bodies was that those programs work best that balance the interests of all parties: consumers, industry and regulators.

In 1990, this experience encouraged the FDA to organize a conference that for the first time brought together drug associations and regulators in the European Union, Japan and the U.S. in order to harmonize the technical requirements for the approval of pharmaceuticals. The International Conference on Harmonization turned out to be an amazing success, which was paralleled by positive results of other cooperative programs that the FDA had launched in the U.S., largely in order to save resources.

By 1997, the evidence that collaboration works was so overwhelming that Congress passed FDAMA, a seminal law that directs our agency to carry out its mission, as much as possible, in cooperation with all of our stakeholders.

These formative experiences -- which have taught the FDA to rely on high scientific standards as the best guarantee of public health protection, and on cooperation as the most efficient way to make those standards a reality -- today guide all FDA operations.

They will guide us as we set out next year to finalize the professional use segment of the 1994 proposal, and as we continue to seek risk-benefit data for the consumer use products that will be on our agenda perhaps a year later.

I am glad for this opportunity to invite your industry to join us in this effort. Your firms and our agency share the common goal of protecting the health of American consumers. Let us, therefore, work together to find the answers that have avoided us for so many years. Let us make a concerted effort to finalize a monograph that would serve our shared purpose best, by fully embracing the principles of public health protection. Thank you.