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Margaret A. Hamburg, M.D., Commissioner of Food and Drugs - Remarks at the Consumer Healthcare Products Association Annual Executive Conference

Remarks as Delivered of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
at the
Consumer Healthcare Products Association Annual Executive Conference
March 12, 2010

Good morning. I am delighted to be here today—and I must confess that I was looking forward to a meeting in sunny Miami. Not quite, but this is a beautiful and relaxing setting. I want to thank Linda Suydam in particular for inviting me. Linda, as you know, was one of FDA’s finest before she came to lead CHPA. Clearly FDA’s loss was CHPA’s gain. And I wish you luck, Linda, on your next step as you complete your work on CHPA and head on. Whatever you do, I know you will make a contribution.

Sometimes when I speak to groups, I have to search for common ground—for a place to begin the discussion. But today, finding that common ground is easy. Interestingly, both CHPA and the FDA trace our histories back to the 19th century, and we both still serve the American public today. In fact, our histories are intertwined in a fundamental way.

For us, those early years were rough. It was President Abraham Lincoln who created the Division of Chemistry that would evolve decades later into the Food and Drug Administration.

But in 1862, that high-level support apparently didn’t translate into much. The office was in a dark, dank basement. My earliest predecessor reportedly had only enough resources to analyze a handful of grapes as his first health and safety study.

Some 19 years later, in 1881, a group of proprietary medicine manufacturers met in an office in New York’s financial district. Together, they formed the Proprietary Medicine Manufacturers and Dealers Association and vowed to “protect and advance the interests of the trade; and the purity and efficiency of proprietary medicines.” More than a century later, CHPA’s bylaws still begin with a similar clause.

Our organizations first crossed paths in 1906 when the Proprietary Association helped advocate for the passage of the Pure Food and Drugs Act. So I guess a belated thanks is due.

Today, both CHPA and the FDA work to ensure that Americans have access to safe and effective medical products, tools people use every day to support their health. And in fulfilling this goal, our success rests heavily on trust. For us to be effective, Americans must trust that that the products they use every day are indeed safe and effective. They must trust that we are doing our jobs.

This morning, I’d like to share some ideas about how the FDA is planning to serve the public health in new and innovative ways—and how we can work on common challenges together to improve the health of the American people.

The late Senator Kennedy, one of our nation’s greatest champions of public health, once said that FDA is the most important health agency in America. Some people raised eyebrows at that thought, but every day I spend on the job, I gain a deeper understanding of what Senator Kennedy meant…and a fuller appreciation of just how right he was.

Before taking this job, I did not fully appreciate how crucial—and how unique—the FDA is. It is a science-based agency with the mission of promoting and protecting the public health. And as such it commands a special role in addressing threats to health—and as serving as the gateway for products that people need and must count on.

Our responsibility and reach are enormous. Consider that the FDA regulates more than 1 in every 5 consumer dollars in this country—food, drugs, medical devices, vaccines and biologics, cosmetics, dietary supplements, tobacco products, animal drugs, even some radiation-emitting products.

Even considering just the thousands of over-the-counter products that you manufacture and sell, we are responsible for the safety of items people really care about and that matter for their health, safety and well-being.

The bottom line is that 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 it be done fully and responsibly.

That is why Teddy Roosevelt responded to Upton Sinclair’s exposé of the food industry at the turn of the last century and, with the help of organizations like your predecessor, signed the Pure Food and Drug Act. The law vowed to protect the public against “misbranded, or poisonous or deleterious foods, drugs, medicines, and liquors.”

Today, that duty to the public health is still our core charge. Public health is the compass I try to use to steer the FDA through sometimes-choppy waters.

I have noticed that many people ask whether the agency is 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 have pushed forward with a public health agenda for the agency.

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 the safest, most effective medical products possible. The FDA's role is to support this access and, in doing so, to promote health, prevent illness and prolong life.

Nearly two decades ago, when I first began my career in public health and accepted the position of New York City Health Commissioner, my great-aunt Winnie was baffled and upset by my decision. She complained to my father that she just couldn't understand why I would give up the opportunity to be a "real doctor."

My father tried to offer some consolation by telling her that I would still be a real doctor, but that instead of having one patient at a time, I would have eight million. Aunt Winnie didn’t buy it—but I did.

And now I guess I have more than 300 million patients.

This is a responsibility I take very seriously.

A fundamental principle of public health is prevention, and we seek a shifting of the paradigm from response to prevention. For example, in the past, FDA has been criticized in the area of food safety—for waiting for large outbreaks of serious illness before initiating recalls.

Now, we are identifying contamination earlier and taking reasonable steps to protect the public before people start getting sick.

Recently, you may have read about the discovery of salmonella in one supplier’s hydrolyzed vegetable protein, or HVP, a substance that is widely used as a flavor enhancer in products. FDA became aware of this problem through a report to our new reportable food registry from a customer of this company.

Within a week, we inspected the facility and found a major salmonella contamination problem. So, working with the food industry and others, we designed a balanced response to contain the problem before there were any known illnesses.

I am pleased to say we were successful. We managed to respond quickly and effectively to the problem.

Our ultimate goal, though, is to prevent situations like this from arising in the first place.

Of course, this same public health approach extends to all our regulated products, including those that you make.

If companies are too slow to recognize and respond to serious safety problems—and if companies do not notify FDA quickly about significant problems—then patients may suffer unnecessarily…or even die preventable deaths. And our credibility will suffer…and it will deserve to suffer…and so will the credibility of industry.

FDA cannot sit back and watch this happen. When justified to protect the public, we will take strong action.

At the same time, just as with food safety, our real goal is prevent problems from occurring in the first place.

Good manufacturing and quality standards exist for all the products you make. I’m sure many of the companies here today already have exemplary compliance programs. This is something that I urge every company here to develop and adhere to.

And as we move forward together to improve product safety, FDA must also be vigilant about health claims that mislead the public.

I know that CHPA members are very careful to follow the agency’s guidance on what can be said about your products. But not everyone out there is so careful. And when misleading claims are allowed to persist, that undermines the market for legitimate products.

About a year ago, as the nation faced the emerging H1N1 influenza pandemic, in addition to working with manufacturers to license a safe and effective vaccine in record time—and in addition to helping make new antivirals, diagnostics and protective equipment available—FDA immediately recognized the potential threat of health fraud.

And sure enough, companies marketed scores of special products that supposedly killed or protected against the H1N1 virus: medicated body washes, air sanitizers, high frequency vibrating machines, even unapproved vaccines.

FDA quickly established an anti-fraud team and issued more than 5 dozen warning letters to offending websites with a compliance rate of more than 90 percent.

We also made national news by ordering Tamiflu online and showing the public that it was counterfeit—and possibly dangerous.

Of course we were pleased when one trade press commentator wrote: “FDA is taking extraordinary measures to protect the public from illegal H1N1 products…”

But in the future, I hope FDA’s work protecting the public from false and misleading claims will be neither surprising nor extraordinary.

As I said before, there is tremendous overlap in the efforts of FDA and CHPA. We both aim to support—and serve—the health of the public. Your products can provide important health benefits, while also carrying real risks. In keeping with a public health approach, FDA aims to maximize the benefits of medical products while minimizing the risks.

I respect—and applaud—many of the efforts you have undertaken with the same goal in mind.

I am familiar, for example, with your program to prevent medicine abuse by teenagers. Your multi-pronged effort has managed to engage a number of important partners and get real results against dextromethorphan abuse.

I am also aware that CHPA is leading efforts to rethink the bottles used for OTC medications for young children. Tens of thousands of children still overdose each year, and yet the technology used to prevent accidental ingestion has hardly changed for decades. New tools—such as single-dose packs and flow restrictors—must be explored for their potential to prevent unnecessary suffering.

FDA will work closely with CHPA as you push forward with these and other efforts. We launched a Safe Use program of our own last fall aimed at reducing the disturbing number of injuries and deaths that result from errors in medication use.

By working with committed partners, including hospitals, clinicians, manufacturers and patients, the FDA will identify specific candidate cases linked to significant, preventable harm; determine whether the situation warrants intervention; and take appropriate action as needed.

Already, as part of the Safe Use initiative, the FDA has released new guidelines for dosing cups, droppers, syringes and spoons. Confusion about exactly how much of a drug to administer was resulting in millions of accidental overdoses among young children. We hope that a simple fix—specific guidelines for clear, consistent labeling and dosing instructions—will help protect the public.

I would like to speak briefly about two efforts that directly relate to the over-the-counter business.

First, as many of you are aware, FDA is studying the recommendations of FDA advisory committees that last June discussed changing the regulation of acetaminophen. This is an important medication that reduces the pain of millions of patients every day … but overdose is also the leading cause of acute liver failure and is responsible for hundreds of deaths each year. Shockingly, about half of people who overdosed did not intend to—they just took too much inadvertently.

And this problem has gotten worse over the last decade.

As FDA considers how to handle this challenge, I know that many of you have sent us data and have strong views. We will review these communications carefully. I want you to know our bottom line is maximizing the benefit of acetaminophen while reducing the risks. We will adopt an approach that makes sense for public health.

Second, I would like to comment on—and commend-- a recent positive step taken by one of your members to rename an over the counter medication to reduce confusion.

Many brand names are important and trusted—and I understand the temptation to extend them to new lines of products. But when patients can be easily confused about the active ingredient in medications, naming can become misleading and potentially dangerous.

I ask each of you to examine the naming of your products with this in mind.

Let me now turn to another broader challenge we face together—the safety of the supply chain.

As you can imagine, the regulatory tasks at FDA have grown immensely more complicated by the growing percentage of products that come from overseas. As much as 20 percent of our food, 40 percent of our drugs, and 80 percent of the active pharmaceutical ingredients used for drugs in the United States are now imported.

FDA-regulated products are currently imported from more than 150 countries, with more than 130,000 importers of record and from more than 300,000 foreign facilities.

This year, we expect that nearly 20 million shipments of food, devices, drugs, and cosmetics will arrive at U.S. ports of entry. Later today I’m visiting Port Everglades to get a better look at this challenge. Just a decade ago, that number was closer to 6 million, and a decade before only a fraction of that.

Simultaneously, the supply chain from manufacturer to consumer has become more and more complex, involving a web of repackagers and redistributors, and making oversight significantly more difficult.

In recent years there have been a number of truly disturbing contamination incidents involving substances such as melamine in imported pet food and dairy products and diethylene glycol, or DEG in toothpastes. And of course, you may remember the contaminated heparin—the blood thinner with tainted ingredients from China that took lives and sickened many others.

Such episodes are particularly troubling because they represent economically motivated adulteration—truly despicable acts of seeking profit by putting lives at risk. We see this also in the worldwide marketing of counterfeit medical products.

Daily there are also problems with less intentional, but still concerning contamination or other safety issues that must be addressed.

This spectrum of problems were not on the horizon when the modern FDA was created. Imports were a tiny part of the products used in our country, and our import inspection system was small and unsophisticated. And though we are starting to build our capacity- our system to engage on a world-wide basis- it is an enormous task which only continues to grow.

The estimated 20 million shipments of FDA-regulated imports that will come into the country this year will be handled by fewer than 700 inspectors. Though these employees work tirelessly, they typically are able to examine less than one percent of these products before they enter the U.S.

We need new strategies.

Last month I had the opportunity to announce the unveiling of a new computerized inspection system that should help alleviate this problem. The program is called PREDICT—the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting.

Using algorithms programmed by FDA, PREDICT ranks incoming shipments on the basis of risk assessments, such as the quality of previous shipments from a company, or the inherent risk of the product. It can incorporate the latest information—news of a bad shipment of the same product discovered in an Italian port, say ... or a typhoon that damaged crops in a part of Thailand.

Our inspectors still have only enough resources to check a tiny percentage of shipments, but PREDICT gives them the power to check the riskiest ones…and allows well-documented, safe imports to move through inspection much faster than before. Currently PREDICT is only being applied to food imports, but ultimately it will benefit all imported products that we regulate.

But clearly, we cannot have a system that relies on screening things at the border. FDA simply does not have the resources to examine every shipment of products from overseas. Nor can we inspect every foreign manufacturing site.

Thus, the new paradigm of globalization requires us to build partnerships to manage our responsibilities.

We’ve established new offices overseas to serve as a regional hub to conduct our own inspections but also to strengthen our foreign presence in important ways. We must work more closely with sister regulatory authorities, sharing information, strategies and even inspections and other responsibilities…and we must help to train regulators and strengthen regulatory capacity in developing countries where their systems are much less mature.

It is also essential that we work to harmonize standards and approaches across nations.

But ultimately, it is up to industry to shoulder much of the load, by improving controls at the point of production with its suppliers. Manufacturers have the primary responsibility for the quality and safety of their products.

We’re encouraged by initiatives such as SIDI, or Standardizing Information on Dietary Ingredients, which members of your organization are using to enable companies to assure the qualifications of their vendors.

In this day and age, companies must be able to effectively demonstrate that safety, quality and compliance with international and U.S. standards are built into every component of every product and every step of the production process.

Some companies already do a terrific job at this, tracking where and how their products are made and the path taken to reach our shores. Obviously they have a huge stake in assuring confidence in the safety and quality of their products and their brands.

These practices need to become standard throughout industry. And FDA will work with you to set standards for technologies and other approaches that can help you strengthen the safety of your supply chains.

Before I conclude, I would like to take a moment to look to the future toward a promising pathway for innovation—both for FDA and for industry.

The rapid pace of change in science and engineering presents tremendous opportunities for health. I am sure that you are all investing in new types of products to help Americans in many different ways.

But just as biomedical and life sciences research has evolved in the past decades, regulatory science—the science and tools we use to assess and evaluate a product's safety, effectiveness, potency, quality and performance—must also evolve.

I often use the metaphor of a rower on the Potomac with one powerful arm and one scrawny arm. Rowing with all his or her might, the boat cannot travel in a straight line. So it goes with U.S. biomedical advances over the past several decades.

Basic science, spearheaded by NIH, is pulling hard. But it also takes muscle to create innovative tools, standards, and approaches for the efficient assessment of medical product safety, efficacy, and quality.

Without these complementary advances in Regulatory Science, promising therapies may be discarded during development for two simple reasons: (1) we lack the tools to recognize their potential and (2) outdated, inefficient review methods unnecessarily delay the approval of critical treatments.

On the other hand, both significant dollars and many years may be wasted assessing a novel therapy that with better tools might be shown to be unsafe or ineffective at an earlier stage.

Strengthening Regulatory Science is an urgent challenge for the collective minds of academia, industry, and government. Advances in this field will help modernize product development to provide better tools, standards, assays, disease models, and science-based pathways to improve the speed, efficiency, predictability, capacity, and quality of product development, evaluation, and manufacturing.

A robust, state-of-the-art field of regulatory science is essential to FDA's work—and, more importantly, it represents an important driver of our nation's health and economy. It is a goal that I think we must all embrace.

If we do so, I am confident we'll be able to speed the movement of new discoveries—of innovations—to practical applications.

Several partnerships with industry and universities to advance regulatory science are starting to bear fruit.

But we still have many more steps to take. I am encouraged that the President’s FY 2011 budget includes the first ever initiative for regulatory science. And just several weeks ago, I sat on stage beside HHS Secretary Kathleen Sebelius and NIH Director Francis Collins to announce an important collaboration between FDA and NIH to help bring the fruits of science to patients—to bring them, in the words of Secretary Sebelius, “from the microscope to the marketplace.”

I look forward to continued engagement with you as we define the scientific agenda that can help all of us move forward to provide access for Americans to new products that improve health.

Let me close by quoting the man who planted those first seeds that have grown, over a century later, into today’s FDA. Theodore Roosevelt said, “In a moment of decision the best thing you can do is the right thing. The worst thing you can do is nothing.”

Let us remember this as we move forward into this new decade. We face many of the same challenges—challenges that can sometimes be difficult to face head on. Yet we must both remain strong, ready to take action and make the right decisions for the millions of Americans who are relying on us.

After all, whether we are talking about enforcement, import safety, regulatory science, or innovation, our organizations seek the same thing: confidence. We want the American people to trust us to provide them and their children with safe and effective medical products.

And as we move forward, as we continue to strengthen our organizations and build that trust, we must continue these conversations. Only then can we effectively work together to promote, protect, and serve the public health.

Thank you.