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Margaret A. Hamburg, M.D., Commissioner of Food and Drugs - Remarks at the United States Pharmacopeial Convention

Remarks as Prepared of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
at the
United States Pharmacopeial Convention
April 23, 2010


Good morning, and thank you for that kind introduction. It’s a pleasure to be here today and to address you at this important meeting.

It’s particularly wonderful to be speaking with a group whose relationship with FDA stretches back more than a century. Our work together began the moment the Pure Food and Drug Act became law in 1906. The Act endorsed your work and created a formal bond between USP and the old Bureau of Chemistry that preceded the modern FDA.

We were still in our infancy in 1906—there had been a small Bureau created by Abraham Lincoln four decades earlier. Not well funded, it reportedly had only enough money to analyze a handful of grapes as part of its first investigation and was housed in a basement in the US Patent Office, where—and I quote—a “great dampness,” accented by “acid fumes,” prevailed. USP, on the other hand, had been around since 1820, when you began devising and reinforcing scientific standards for the strength, quality and purity of drugs…and, as my one of my predecessors said at your last conference five years ago, “ushered in a new age for American health care.”

Not only have we shared a common public health mission, we have even shared senior leadership. Our first Commissioner, Harvey Wiley, became your president. Your current president once held a key role in our Center for Drug Evaluation and Research. And now, you’re working with our Office of History on an exhibit commemorating our relationship.

I must say, I feel like I’m talking to old friends.

Together, we have tackled a variety of important projects. We have collaborated on scientific standards for drugs, medical devices, and other products; created a Reference Standards program as well as standards for insulin and antibiotics; and established reporting programs for drugs and medical devices.

But there is still a great deal of work to be done. This morning, I’d like to tell you a little about myself, and my vision for the role of FDA…and then talk about ways our organizations can continue to support each other in the years to come.

I must admit that before I took this job, I did not fully appreciate how crucial—and how unique—FDA really is. As a science-based agency with the mission of promoting and protecting the public health, it commands a special role in addressing threats to health.

Our goal is to prevent threats before they even arise, but it’s also to help deliver safe and effective food and medical therapies to the American people.

We want FDA to serve as a gateway—not a bottleneck—for the products that people need and count on everyday.

Like you, we are responsible for the oversight of products people really need, products they care about, and products that matter in a most fundamental way to their health, safety and well being. And in this sense, our responsibility and reach are enormous.

As you know well, the FDA regulates products that account for between 20 and 25 percent of every consumer dollar spent in this country. This includes food, drugs, medical devices, cosmetics, dietary supplements, animal drugs, even some radiation-emitting products.

Plus, for the first time in its history, the FDA has also been given the power to set and enforce standards to regulate the manufacture, marketing, and distribution of tobacco products.

The bottom line is: if FDA does not do its job well, there is no one to backstop us. Ours is a unique role, and it is critical that we do it completely and responsibly.

After I became Commissioner many people began asking whether the agency is now leaning pro-industry or pro-consumer. This is the wrong way to think about FDA’s role. Both consumers and industry groups have a tremendous stake in a strong FDA that takes science-based action on behalf of public health.

And that’s why we’ve pushed forward with a public health agenda for the agency. But people sometimes ask, but what does that really mean? The Institute of Medicine has defined the mission of public health as "fulfilling society's interest in assuring the conditions in which people can be healthy." To be healthy, people need access to a safe and nutritious food supply and to innovative, safe, and effective medical products. The FDA's job is to support this access and, in doing so, to promote health, prevent illness, and prolong life.

This means operating from a specific set of principles. As a public health agency, FDA must work to prevent problems, balance risk versus benefit, and monitor outcomes.

An FDA that can help promote health and well-being through quality products and acts quickly and strategically to protect consumers from unsafe products earns the trust and confidence it needs to do its job well.

But as you can imagine, this is easier said than done. We have a challenging task. And we are performing this task at a challenging time.

My goal as Commissioner is to use the principles of public health to address these challenges head-on.

For one thing, science is evolving at a breakneck pace…so fast that discovery has begun to outpace the delivery of life-saving products for the American people. So one of my main priorities as Commissioner is increasing FDA’s scientific capacities and strengthening the field of regulatory science.

Billions of dollars have been invested in biomedical research—an effort that is indispensible for medical progress—but this research will not translate into real-life therapies for those who need them unless we make an appropriate investment in regulatory science...the science and tools we need to assess and evaluate a product’s safety, efficacy, quality and performance.

Just as biomedical science has evolved in the past decades, regulatory science must also evolve. We must harness advances in science and technology to ensure that we have the most effective and efficient regulatory pathways to address the opportunities before us. A robust, state-of-the-art field of regulatory science is essential to FDA's work, yet it is more than that—it represents an important driver of our nation's health and economy. It is a goal that must be fully embraced by academia, industry and government.

We cannot afford to rely on 20th century approaches to review 21st century products.

At the same time, the world in which the products we regulate are discovered, developed, and marketed is effectively getting smaller and what we consider “our” products are in reality global commodities. An estimated 20 million shipments of FDA-regulated imports are expected to come into the country this year from more than 150 countries. Just ten years ago, that number was closer to 6 million.

Needless to say, new approaches are essential to ensuring that the food and medicines consumed by Americans every day are safe and quality-assured. Clearly we cannot inspect all imported goods as they come over the border. In addition, FDA simply does not have—and will never have—the resources to inspect every foreign manufacturer, or every shipment of products from overseas. So the new global reality requires that we build partnerships to handle the load.

This means working closely with other national regulatory authorities, other international and national organizations, and with industry. We must find new ways to harmonize standards and approaches, as well as to share information.

That’s why responding to the growing demands of globalization is another one of my main priorities.

So what does this mean for FDA and USP? Clearly many of our interests and priorities are aligned. In some earlier discussions with USP, we have talked about opportunities and strategies to promote public health through our work together. There is a lot to be done.

Let me start with one of the most pressing tasks before us: updating monographs. In March 2008, when the heparin contamination situation first became evident, FDA’s Center for Drug Evaluation and Research met with USP to update public standards for heparin.

We formed a task force, met with experts, and then USP updated its Heparin Sodium monograph to include three new tests—followed by several more the next year—that were developed by FDA and validated by USP.

This type of collaboration is essential…and can be used as a model for how to move forward proactively to modify monographs in a way that they identify counterfeited or intentionally adulterated products…before they enter the healthcare system. Now, we must jointly identify drug ingredients and products that would benefit from an up-to-date monograph…starting with those that have the greatest impact on public health.

In keeping with our public health principles, this would allow us not only to respond to public health crises that may arise, but also to establish standards that would help us to prevent them from happening at all. And, of course, it would continue to strengthen your organization and allow you to fulfill your public health mission, as well.

We also share responsibility in promoting public health by establishing and monitoring standards for quality that are used by the pharmaceutical and health care industries. USP standards are an invaluable tool to FDA in assuring compliance with our regulatory standards and protecting the public from adulterated drugs.

FDA’s Office of Regulatory Affairs supports the USP Reference Standards Program through a Cooperative Research and Development Agreement. This is particularly important to FDA because USP’s standards are considered definitive and are used in the development and analysis of high-quality pharmaceuticals worldwide. And, as of now, ORA labs make up more than a quarter of the USP collaboration studies.

Three future initiatives that will take place under this agreement will expand efforts to promote the purity, quality and efficacy of current and new drugs.

First, Reference Standard Candidate Assessments will test standard candidate materials that are controlled substances.

Second, through efforts to combat economic adulteration, FDA and USP will exchange information on hand-held device applications designed to screen drugs for adulteration or contamination and explore ways to integrate the requirements of those new technologies into USP’s documentary standards.

And third, we will assist in the development and modernization of USP monographs providing enhanced tests and assays to better assess and characterize drug ingredients and products.

We also want to work with you to ensure the safety and quality of food and food ingredients for Americans. USP joined us in this pursuit in 2006 when you acquired the Food Chemicals Codex from the Institute of Medicine.

Since its creation in 1966, the Food Chemicals Codex has played a role in setting the standards for the identity and purity of food ingredients. And this continues today at USP, as you attempt to develop new monographs and update existing ones to support industry in their efforts to meet FDA requirements for safety.

In the coming years, we would like to share information about ways to help manufacturers make and market safe dietary supplements. We would also work together to develop methods to detect contaminants, including pharmaceuticals, in dietary supplements and foods.

And, of course, in this increasingly globalized world of ours, we must continue to strengthen our partnerships on a national and international level.

You have been extremely successful in cultivating your relationships abroad—in the past five years, you have physically expanded into Switzerland, India, China and Brazil. We too have embraced the need to be physically present abroad, and, in the past 15 months, have established FDA posts in China, Europe, India and Latin America.

We are eager to work with you as we interact with our counterpart agencies and industry overseas to help establish science-based standards for the quality of the products that we regulate. We are both integral parts of the international regulatory community, and we look forward to working with you in these new outreach efforts.

This will undoubtedly help us in our efforts to help protect American consumers from substandard food and drugs that are imported into the US.

And these are just a few of the things on our agenda for the next few years. As you can tell, we have a busy time ahead of us…plenty of time to make a tangible impact on the public health. And I am confident that we will achieve an enormous amount, together.

In 1918, Merck displayed a poster for National Pharmacy Week that illuminated USP’s recognition in federal legislation. “Here is a book,” it read, referring to USP’s book of standards, “written by a group of private citizens who have done their task so well that they have earned from Congress this unprecedented mark of confidence.”

You continue to live up to that mark of confidence. And we are eager to continue our work with you.

Thank you for your time this morning…and for what you do every day.