Remarks as Delivered at the Food and Drug Law Institute

Good afternoon. Thanks, Miriam, for that warm introduction. I think your introduction was just about the warmest thing in D.C. today.

As Deputy Secretary, I oversee huge agencies like CDC, NIH, CMS, AHRQ, and — of course — FDA. I try to make sure they are not at cross purposes, and unfortunately, there’s a lot of opportunity for that. It’s like the joke about the NIH and FDA scientists talking over coffee. The NIH scientist bragged that he had just discovered a drug that would confer immortality. The FDA scientist shook his head and said that finding out if it actually works would take forever.

Seriously, though, over the past several years, President Bush and Secretary Leavitt have been working hard to enact some serious and much-needed reforms to improve health care in America. Our efforts are built on a few simple beliefs. Our government should: empower the consumer, help the needy, and allow free markets to innovate and excel wherever possible. The federal government can help by increasing competition, expanding scientific frontiers, and bringing the best minds to our most pressing problems.

I’d like to talk a little about some of the things we’ve accomplished by applying these principles. Then I’m going to discuss how we’re using a similar approach to food safety.

Medicare Part D: For example, one of our most substantive reforms has been Medicare’s Part D prescription drug program. We know from every other sector of the American economy that consumers win when companies compete for their business. So in 2003, President Bush worked with Congress to create a system in which seniors can choose between companies competing to provide seniors with prescription drug coverage. The Administration decided to use the resources of the federal government to establish and fund the framework rather than to mandate decisions that consumers and companies would prefer to make for themselves. Congress defined a basic plan for seniors, but 90 percent of seniors made their own choices and chose plans that offered more options. As a result of this competition, more than 38 million Medicare beneficiaries now have some form of prescription drug coverage. Costs are down, and satisfaction is up — 86 percent of seniors tell us they’re happy with their plan. That’s staggeringly high praise for any program — government-run or not.

Stem Cells: We have also made progress in stem cell research. A decade ago, scientists discovered how to isolate stem cells harvested from human embryos. It was an amazing scientific breakthrough, but one fraught with deep moral questions.

So in 2001, President Bush drew a line. He recognized that our society needed to take moral stand so our culture did not go down a dark path that cheapened life. So he decided to fund embryonic stem cell research with ethical conditions to ensure taxpayer dollars would not encourage the destruction of embryos.

And just recently, researchers succeeded in creating genetically matched stem cells from adult cells — a process that does not go into ethical gray areas. President Bush’s courageous decision showed that while we support technological advances, we can do so in a way that reflects the highest values of our nation and our shared belief in the dignity of every life. Now we’re looking forward to seeing what advances and therapies are to come from this new discovery.

Community Health Centers: Another way to promote access for uninsured and underserved Americans is community health centers. In 2001, President Bush launched the Health Center Growth Initiative and set a goal to establish or expand health care options in 1,200 communities across the country. Since then, we have met and exceeded that goal. We have funded 1,236 new or expanded health center sites. That brings the total of comprehensive sites around America to over 4,000 — serving well over 16 million people. In doing this, we are bringing more health care options where before there were few.

Health Savings Accounts: Health Savings Accounts are another example of how we are pressing forward to a brighter health care future. Health Savings Accounts give more citizens more choices, make health care more affordable, and strengthen the doctor-patient relationship. By removing some of the distortions in our tax code, we are helping families gain more control over their health insurance independent of where the work or what type of job they hold.

You all know how health savings accounts work. You open a tax-free savings account in conjunction with a high-deductible, low premium insurance plan. You can use the money in your HSA to pay routine medical expenses and you have the insurance in case of expensive emergencies or hospitalizations. Your employer can also contribute money to your account and help pay for your premium. But the especially attractive thing about HSAs is that even when you leave your job or begin a new year, you keep all of your unspent money — which continues to grow tax free. For 2008, an individual can contribute up to $2,900 and families can contribute up to $5,800 to pay for current medical expenses or save and invest for future medical expenses.

More than four and a half million Americans have already been helped by HSAs. As millions more start to take advantage of HSAs, they will learn how they now have more incentives to get in shape, find the best health care deals, and spend wisely. As a result, we will all feel the benefit as the rise in the costs of health care are controlled by smart consumers and less bureaucracy.

More to Do: Even with this progress, we must do more. That’s why President Bush has set forth many bold ideas on issues from preventing medical errors to personalized health care to disaster preparedness. And across all our issues, we’re working to determine the appropriate role for the federal government and to make changes that will have a long-term impact.

Take food safety, for example. In recent years we’ve seen a rash of problems with our imports and food supply — from tainted spinach to contaminated fish to bad peanut butter.

Our problems with imports of food and other products came to a head last summer. So President Bush charged Secretary Leavitt with determining what the federal response to all of this should be, and what we need to do to protect our imports and food supply.

Food safety is a very personal issue. It touches every single one of us. Each night when we gather with our families to enjoy dinner, the last thing we want to worry about is whether this meal will harm us. We trust that the farmers who grew our vegetables, the ranchers who raised our meat, and the manufacturers who processed our food products are committed to selling us food that is safe — regardless of whether the food comes from a few states away or a few countries away. We also expect experts from our government and other regulatory agencies to inspect and protect our food.

And you know what? Our food is safe. You don’t need to be scared about our food supply. Our food is good — if not always good for you. As Michael Pollan, the author of The Omnivore’s Dilemma, and not someone I typically quote, said in his new book, An Eater’s Manifesto, “Eat food. Not too much. And mostly plants.”

Our markets now offer — and our regulatory agencies ensure — food that is healthier, safer, and more inexpensive than any other time in history. It’s an amazing thing.

In 1929, almost 24 percent of a family’s disposable income was spent on food. In 2005, it had dropped to less than 12 percent. We no longer have significant, long-lasting waves of food-borne illnesses, such as milk-sickness or typhoid. These are very positive developments, and we want to encourage them as much as possible.

Of course, the more inexpensive and plentiful food has become, the more of it people it, and the fatter many get. It is so cheap now to produce low-cost, high-calorie foods with ingredients like high-fructose corn-syrup, that it costs American consumers less to buy technologically sophisticated yet at times nutritionally suspect processed food than it does to buy an equivalent amount of calories of fresh meat or vegetables. So it makes more economic sense for people on limited budgets to eat unhealthy foods instead of healthy foods — and now, two-thirds of all American adults are overweight or obese. Almost one out of every five kids is even overweight. So our low-cost, high-calorie diet and the elimination of food scarcity in large areas of the world are miraculous in some ways, but present challenges as well.

In addition to food being more available, our methods to keep food safe from contamination are becoming even more refined, as are our abilities to trace disease outbreaks back to their food-borne sources. Our capacity to collect and process information keeps growing.

And in some sense, our food safety agencies are victims of their own success in scientific and technological advances. For example, we know a great deal more than we used to about toxicity levels for chemicals, bacteria, and other contaminants and methods to keep food safe from them. Consequently, we as federal health officials have a duty to continually reassess and improve our food safety practices.

Since many of our problems with food and import safety originated in China, when Secretary Leavitt started working on the issue, we started meeting with ministers from the Chinese government. We had very frank conversations in which we explained that while we want Chinese companies to have access to our markets and we want access to Chinese markets too, we need our imports to meet American safety and quality standards. Over the following six months, we hammered out a series of agreements on food and feed and drugs and devices.

As part of this process, Secretary Leavitt, I, and many members of HHS took a long hard look at domestic and international food safety practices. We met with counterparts all over the world and discovered our problems are their problems. As the market for food is a worldwide one, this is a global problem.

And in November, Secretary Leavitt released reports on import safety and food safety that summed up all we had learned. They were the most robust assessment of our import safety system ever made.

In formulating the report and the plans, we visited seaports and border crossings, distribution facilities and wholesale retailers. One observation we made was just how much food moves around America each day. There are 800,000 different sources from which we import all of our goods, including food, into this country. They come through more than 300 different ports. It amounts to nearly $2 trillion a year. That’s about twice the entire gross domestic product of Brazil, and it’s growing every day. In fact, we expect the total value of all our imports to triple by 2015.

People don’t always realize just how much we rely on imported products. During one of his recent import safety inspection trips around the country, Secretary Leavitt stopped in Boston to visit Cheers Restaurant. He asked the owner, Tom, if he used much imported food. Tom said that he didn’t think so.

Tom then asked his chef who replied that he didn’t think so, either.

Later in tour, they stopped by the pantry and refrigerated area. Inside were:

• cod loins from China,
• asparagus from Peru,
• lemons from Mexico,
• lamb ribs from Australia,
• tomatoes from Canada,
• pasta from Italy,
• tuna from Thailand, and
• chocolate from Belgium.

I think if you crack open the pantry of an average American family, you’ll see a similar diversity of origins — though perhaps not quite the wealth of gourmet choices.

When we realized just how much food is imported into America, we concluded that we can’t inspect our way to safety. The volume’s simply too great. We also realized that we need to move an approach that takes snapshots at the border to one that takes a video of the entire process, metaphorically speaking, from farm to table.

Our food safety plan offers a comprehensive, cost-effective, risk-based approach to ensuring the safety of food and feed imported into the United States. It integrates food safety with food defense. It builds safety into every step along the way. It explains how we can target our resources more effectively. It discusses how to defend against both accidental and deliberate contamination. It underscores the importance of modern science and technology.

The plan is organized around the key principles of prevention, intervention, and response.

Prevention means promoting increased corporate responsibility so that food problems do not occur in the first place. We want FDA to address critical weaknesses by reviewing food supply vulnerabilities and then to work with industry to develop and implement risk reduction measures.

The intervention element focuses on risk-based inspections, sampling, and surveillance at high risk points in the food supply chain. These interventions must verify that the preventive measures are actually being implemented, and implemented properly.

And the response element bolsters FDA’s emergency response efforts by increasing its speed and efficiency. It also includes the idea that we need to improve communication between other federal, state, and local government agencies and industry during and after emergencies. Whether a food safety problem is unintentional or deliberate, the need to respond quickly and to communicate clearly with consumers remains paramount. In addition, response efforts should emphasize identifying products of concern as well as assure the public of what is safe to eat.

Last, I want to emphasize again how much of an evolving process food safety is. We’re always learning new things about food. Undoubtedly, unexpected threats that we haven’t planned against will emerge. Consumers may decide that they’re comfortable with more — or less — risk. So there’s no one report or set of standards that could perfectly ensure the safety of our food supply. But we believe that our food safety plan builds in the flexibility and adaptability to cope with new problems as they arise.

In conclusion, never before have people had access to such a diverse, delicious, and amazing food supply as we do. Considering how throughout human history one of the largest problems people faced was having too little food, we truly live in a truly bountiful time. We should be thankful. We should also realize that we don’t have to have seconds or thirds at every meal. Just because we have all this food doesn’t mean you have to eat it. You don’t even have to clean your plate, regardless of what your mother told you. (Sorry, man)

By the same token, never before have people been as aware of the challenges of food safety. But I’ve been very encouraged by our work with the Chinese and with other friends around the world. If we continue our work on its current path, I am confident that we will be able to prevent most food safety crises, respond effectively to any that do occur, and recover rapidly to restore consumer confidence in the safety and quality of the foods we grow, process, and import. Thank you.