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Margaret A. Hamburg, M.D., Commissioner of Food and Drugs - Remarks at the Food and Drug Law Institute

Remarks as Prepared of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
at the 
Food and Drug Law Institute
April 21, 2010


Good morning—and thank you for that generous introduction. It’s a pleasure to be here today.

It’s a little daunting to look out and know that most of you are lawyers, but a pleasure nonetheless.

Last time I spoke to you, I was in the early days of my tenure as Commissioner. I told you then that I looked forward coming back and having more discussions with FDLI and its membership in the coming years. So it is fitting that now, as I approach my one-year mark as Commissioner, I am here once again.

In that speech last August, I outlined my vision for a strong FDA—an agency guided by and dedicated to public health principles. To be strong and effective, I said, we must be vigilant, strategic, quick and visible.

But, above all, we must enforce the law. An FDA that acts quickly and strategically to protect consumers from unsafe products earns the trust and confidence that it needs to do its job well.

Since that time, FDA’s renewed emphasis on enforcement has been recognized—and I am pleased that we’ve been able to see a rise in industry compliance programs…which are the key to preventing problems from occurring in the first place.

This is really encouraging. But we are living at a challenging time. Advances in science, changes in society, changes in the complexity of products and their manufacture, and the impact of globalization on products and on supply chains have led to countless issues, opportunities and threats that were inconceivable just a generation ago. This makes FDA’s job—to promote and protect the public health—more critical than ever…and more complex.

So how do we at FDA make decisions—the right decisions—in a changing world and in often uncertain times?

Today, I want to address that question. I don’t pretend that I’ll address it fully, but I want to go beyond enforcement to discuss the use of FDA’s legal tools to promote the public health.

As you know, the laws governing food and drugs contain provisions that stretch back more than a century. There have been periodic updates, of course. But the science, on the other hand, is constantly evolving…especially today, when unprecedented resources have propelled research forward at a breakneck pace.

This creates a challenge for FDA—how do we use the same set of tools to address an ever-changing set of facts?

The answer is simple. The law does not just give FDA a hammer and force us to use only nails. Instead, it provides us with a wide range of tools that fit a wide range of circumstances.

And by using the variety of tools given to us by the law, we can be more flexible in our regulatory approach.

My job as Commissioner is to address the endless stream of public health challenges that cross our threshold. But the fact is that protecting the public health is not black or white…a product is often not perfectly safe or completely unsafe. Science can help us greatly to deepen our understanding of the issues at hand, yet rarely are there absolute answers. To address ever-changing facts, we must navigate the middle ground, the shades of gray.

And this, as I’m sure you appreciate, can be very troubling at times.

The bottom line is that the law should facilitate—not inhibit—the public health mission of the FDA…so that our response is appropriate for each individual circumstance. And it should ensure that, for unusual cases…or for emerging new concerns… we have the option of saying that we in fact need additional legal authority to reach the right public health outcome.

This morning, I’d like to lay out a vision for what it means for FDA to have a public health approach to the law—and then give you some examples of how we’re implementing this vision at the agency.

It’s a matter of asking three basic questions.

When confronted with a novel challenge in food and drug regulation, FDA must start with the science. The first question we must ask is: what is going on—what does the science, the data, tell us?

But as the science evolves, the answers are rarely simple. New technologies and new products in both food and in health care offer the potential for tremendous public health benefits. Yet there may be new or unique risks that can affect certain populations, and there are unanswered questions that must be considered and pursued.

FDA needs to draw on the very best science possible, within the agency and beyond, to assess new challenges. That’s why my priorities as Commissioner very importantly include both increasing FDA’s science capacity and strengthening the broader field of regulatory science—inside and outside the agency.

This is critical to our work today, and fundamental moving forward.

The second question we must ask is: what is the right policy approach to address the new challenge?

On the one hand, if there is a real risk to the American people, and the risks clearly outweigh the benefits, then the answer is easy: the public needs to be protected.

On the other hand, if we are dealing with a new product where the benefits far outweigh the risks, we should have the processes in place that facilitate a speedy approval.

But most often, the answer is somewhere in the middle. And based on the specific circumstance, we may need to perform additional assessments, provide advice to clinicians or seek additional post-market studies to fashion the best ongoing approach.

That brings me to the third, and final, question. Once we have our best possible grasp of the science and have identified the appropriate policy options…we must ask: how can the law help the agency get as close as possible to the best solution?

No matter what the topic, there is a spectrum of legal options available to the agency. On one extreme, the agency can warn the public and attempt to remove products from the market. On the other, FDA can explain its support for a product’s safety and effectiveness, even against erroneous attacks.

But there is also a great deal that falls between these two extremes…situations that are not easy to resolve and which require judgment to figure out the right path forward. That’s where the agency’s wide range of legal tools come into play.

This is not a new approach. Believe it or not, the FDA has a rich history of creativity in the legal arena…you all, in fact, probably know that better than I.

It dates at least as far back as 1935, three years before the birth of the modern FDA. I’ve become a student of the history of the FDA and was particularly intrigued by this story.

A weight reducer called dinitrophenol, had just been shown to cause total blindness. But back then, the FDA’s hands were virtually tied. And it also caused acute poisoning. The original food and drugs statute prohibited little else but misbranded or mislabeled food and drug products—and the law could only be invoked when such a product had been transported across state lines.

The FDA “Chief” at the time, W.G. Campbell, said that he “regretted that the present Federal law is silent with respect to the control of dangerous drugs.”

Sure enough, the drug was eventually pursued on a misbranding charge—and once the authority of the FDA had been expanded, it was no longer used as a treatment for obesity.

Obviously we are talking about more than taking advantage of technicalities in the law.

Some may say it is wrong for FDA to take a more flexible approach in pursuit of public health goals. They may say that the agency should use only a few well-established tools…in other words, for example, we should treat items as safe and effective until a certain standard of evidence is reached and then—and only then—should they be taken off the shelves.

But I believe that such an approach is neither adequate nor appropriate to serve the agency or the industry—let alone the public health.

It’s not a question of safe and effective and available…or off the shelves. There’s a lot in between.

An approach of extremes puts FDA in the position of not commenting on emerging science, even when that science raises legitimate questions about specific products. This undermines trust and credibility and leads people to turn elsewhere for information and analysis.

And, of course, when the agency’s trust and credibility is in question, industry suffers, too. A binary approach that cycles between what can be seen as false assurance and draconian enforcement can lead the public to doubt the quality of industry products. Companies benefit far more from a flexible regulator that can maintain the public’s confidence.

Not to mention that waiting for the hammer to fall is a very difficult position for any company.

So let me walk through three recent examples of this approach to public health law at FDA.

The most recent example, which I’m sure you’ve heard about, relates to the rotavirus vaccine, Rotarix.

An independent research team based here in the United States found DNA from a porcine virus, something called PCV1, in the vaccine. This researcher was actually just interested in using a new technology and seeing what he could find.

This viral material certainly did not belong in the vaccine and it was not understood how it got there. On the other hand, the vaccine has had a strong safety record in both large clinical trials and in practice, and there is no evidence that this porcine virus strain causes illness in people…or in pigs, for that matter.

Deciding on a reasonable course of action was not easy. We looked at the science. It was reassuring that there was no evidence of safety concerns, but this was complicated by some key unanswered questions, including whether the virus was capable of replicating and causing infection and how had this viral material been introduced into the vaccine…and what did that say about the process of manufacturing.

And then there was the international reality: rotavirus kills about half a million children every year in the developing world. Creating an excessive sense of concern could lead to changes in vaccine practice elsewhere that could seriously undermine children’s health.

In the end, we recommended that healthcare practitioners temporarily pause using the Rotarix vaccine, while we further investigated the situation. Our decision was based in part on the fact that an alternative rotavirus vaccine without the extraneous viral material is widely available in this country. But we did not recall the Rotarix vaccine or state that it is unsafe. We also made it clear that other countries could and should make different judgments based on their local assessment of benefit versus risk. Our recommendation was based on an effort to balance science and data with a certain level of uncertainty…and also a recognition that this was really the first example of an application of new technologies that allowed us to learn more about a vaccine product.

We had to operate within shades of gray and I think managed to do so. And the law supported us. Since then, scientific efforts have been underway to study the vaccine and shed light on the outstanding questions. We will soon hold an advisory committee meeting where we will obtain further expert input and update our recommendations.

In other cases, though, we may have to recall a product. A recent example involved the discovery of salmonella in one supplier’s hydrolyzed vegetable protein—something that I prefer to call HVP, which is a substance that is widely used as a flavor enhancer in products. FDA became aware of this problem from a company that had purchased some of the product for use in their manufacturing. And we learned about this through a report to our very new reportable food registry. So I think that’s an additional example of how some of our new examples are shedding light on public health concerns.

So we moved swiftly to examine the situation. Within a week, we inspected the facility and found a major salmonella contamination problem, one that potentially affected more than 10,000 different products.

But again, deciding on a policy solution was difficult. Four months had already passed since the time that the contamination might have initially occurred, yet CDC was not reporting an outbreak with this strain of salmonella similar to the one that we found. There were no reports of illness, but we knew there was contamination. So should FDA launch a major recall, or do nothing and wait? That was the set of questions before us.

But we decided: neither. We were able to find a more balanced approach, one that accounted for the complexity of the issue. After consulting with a wide range of people, we decided to recall all products that did not have a “kill step” involved in their preparation—in other words, all products that were not treated by companies or cooked by consumers in some way that would kill the bacteria. This meant several hundred products were recalled instead of 10,000.

We also permitted companies to recondition their HVP by notifying the agency and hearing back quickly.

We worked collaboratively with the food industry to accomplish these steps, and verified compliance through inspections. This approach protected the public from illness, without going overboard. And it was well within our legal authority.

Let me turn to a third example. Bisphenol-A is an industrial chemical that has been found in hard plastic bottles and in the linings of metal-based food and beverage cans since the 1960s. Traditional toxicology studies had supported the safety of BPA. More recently, though, recent data from a set of animal studies using newer approaches has led both The National Toxicology Program at the NIH and the FDA to express some concerns about the potential effects of the chemical on the brain, behavior and prostate gland of infants and young children.

Based on this concern, FDA, working with NTP and others, has developed and is now implementing a collaborative research program to answer some critical questions and deepen our understanding about BPA’s effects in animals and in humans.

We also have given thought to the legal tools we might need to understand more about the use of BPA and to take action, if appropriate, if our research identifies more serious concerns.

Currently, BPA is regulated as a food additive under regulations from the 1960s. Under this approach, FDA does not receive information about the products and use of BPA—any manufacturer can begin to use it for approved purposes. Also, changes in status must be accomplished through rulemaking, which can be quite burdensome and lengthy, as I’m sure you all know.

In the last decade, FDA has established a more modern approach to food contact substances, which permits the agency much greater authority to understand the use of chemicals and to modify these uses as science evolves.

FDA recently made clear that we would prefer to utilize this modern framework for BPA, although accomplishing this may require action by Congress.

In this case and others, FDA should not be shy in pointing out where different legal approaches may provide the agency with the authority to do its job well and credibly.

Recognizing the complexity of the challenges facing FDA—and facing public health law—is another way of recognizing the immense responsibility that this agency has. We rise to that challenge by searching out the best possible science, identifying the right policy options, and then finding a legal path to move forward.

Ducking the challenge by simply saying we do not have the authority to act or speak to a problem of public health does not do the public—or industry—any favors.

Of course, there will be times when novel challenges emerge for which FDA does not have authority to take all necessary action.

In many cases, we will work together to find a solution—like we did in the 1920s when we redesigned the canning process for olives and other high-risk foods after a family died of botulism. Or in the 1980s, when I first began my work in public health, when we collaborated to speed the development, production and approval of HIV drugs.

In other cases, especially when the public health is at stake, FDA will explain its concern and call on industry to do what is needed to protect the public.

Some companies may think—we can’t be required to do this. It’s not in the law. But other companies, I suspect, will recognize that the public’s trust is the foundation of market success for food and drugs.

If FDA can provide a compelling explanation of the science and policy, I will expect companies to do the right thing, to take action, and to support efforts to change the law as needed to prevent problems in the future. Because together, we carry the sacred burden of safety.

And as I conclude, I want to underscore how much I value public health law for all that we do. This approach follows the law as written. But it also appreciates the flexibility and spirit of the law…something that FDA has recognized for as long as the agency has existed.

I will leave you with a quote from the FDA’s founding father, Teddy Roosevelt: “In a moment of decision,” he said, “the best thing you can do is the right thing. The worst thing you can do is nothing.”

We all play a role in addressing the most pressing public health challenges of our generation. But if we do nothing—if we don’t use all the tools we have to protect the health of the public—we will never move the debate forward. So let us heed Teddy Roosevelt’s words and use every tool we need to do the right thing.

The law provides many options to FDA, but it should never be an excuse to do nothing when the health of the public demands our action.

So thank you very much for your time—and for all the work you do.