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Mark B McClellan, MD, Ph.D. - National Press Club

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

Speech before
National Press Club in Washington, D.C.,

Remarks by

Mark B McClellan, MD, Ph.D.
Commissioner, Food and Drug Administration
August 8, 2003

Thank you for having me here today. I see many of the FDA press corps here. In the eight months since I’ve been FDA Commissioner I’ve been impressed by their work. They’re smart, and they’re dedicated.

This afternoon, I have an important topic to discuss with you: our new efforts to enforce the law to protect the health of the public. There are two main functions of the FDA – to protect and to advance the health of Americans. Protecting the public health has always been the agency’s first responsibility. First and foremost, consumers need to have confidence in the safety and the effectiveness of the products that they use. Unsafe or ineffective products are a threat to the public health.

This is nothing new for FDA. One of the FDA’s first actions involved the case of the United States versus Eleven and One-Fourth Dozen Packages – listen carefully – of Mrs. Moffatt’s Shoo Fly Powders for Drunkenness!

And almost a hundred years later, we are still here to protect Americans from modern snake oil salesmen. Just this week, we took action against the company that makes Miracle II soap and skin moisturizers, products that among other things claimed to treat AIDS and ulcers. In fact, as I’ll talk about more later, I think it’s more important than ever that Americans are protected against misleading claims about benefits or risks of products that are not based on sound science.

But FDA’s mission has become much more complicated. There are unprecedented levels of spending on developing new medical treatments – around $100 billion or more this year alone – yet fewer new products are coming in to the agency than in years past. We need to do more than ever to help make sure that the insights from biomedical science turn into safe and effective medical products more quickly, and at a more affordable cost. With better knowledge than ever of how people can take steps to improve their health through their own choices, including choices about what they eat, and with a greater potential than ever for healthier foods and consumer products, we need to find better ways to help empower people to make informed choices to improve their health. In short, FDA has greater opportunities to advance the health of Americans than ever before.

At the same time, though, we are unfortunately facing some much more challenging and difficult threats to the health of the public – ones that are much more sophisticated and complex than those of the last century, and ones that require new approaches to public health protection. Threats of more sophisticated and large-scale criminal activity. Threats from potentially unsafe medications and foods that are based on increasingly complex production processes. New infectious disease threats. And it’s now a regular part of the job of the FDA Commissioner to get classified briefings about potential terrorist threats. Altogether, we have the responsibility for assuring safety in over 20 percent of America’s consumer economy – an amount that’s growing every year – and it’s the part of the economy that has the greatest potential to affect the health of our nation, for better or worse.

I’m going to talk about what the FDA is doing to confront these critical challenges.

Introduction

I want to begin by thanking John Taylor, our Associate Commissioner for Regulatory Affairs and FDA’s “Top Cop,” for bringing a renewed commitment and creativity to FDA’s most important tradition – effective consumer protection. John and his dedicated staff of over 3,000 inspectors, investigators, and field officers – deployed all over the country and around the world – are working to safeguard America’s food supply and medical products against all of these increasingly complex and challenging new threats.

John and his staff have also worked hard to develop and implement FDA’s enforcement strategy. This strategy is an integral part of FDA’s strategic action plan – a plan I’m proud to say reflects the best ideas of all of the agency’s senior professional staff. The core element of that plan is what we call efficient risk management: using the best biomedical science, the best food science, the best risk analysis and risk management science, and even the best economic science to do the most we can with the resources and authorities we have to protect the health of the public – without imposing costs that unnecessarily make foods and medicines less affordable or available.

We are using an enforcement strategy based on efficient risk management because we have to. The number of medical products – drugs and devices – that we regulate now exceeds 150 thousand, far more than ever before, including many more complex products than ever before. And there are almost 3,000 investigational drugs under development, in the process of developing the evidence needed for FDA approval – far more and more sophisticated products than ever before. There are more and more diverse dietary supplements on the market than ever before – and they are now used by most Americans. And Americans have a broader range of food choices than ever, including over 6 million food imports this year – with the import numbers growing rapidly. These trends are generally good things: they mean that Americans have more opportunities to enjoy and improve their lives. But at the same time, there’s no question that the increased volume and complexity in the areas that we regulate has brought new challenges in meeting our responsibilities. While we’ve received some valuable new resources for carrying out our mission to enforce the laws to protect the food and drug supply, the growing size and complexity of our job means that we must use the best science and the best new ideas.

Many people think that protecting the public from harm from the products we regulate is an either-or proposition: Either you get tough with companies, possibly at the expense of helping people get better products faster and more cheaply, or you go easy on companies, possibly at the expense of patients being misled or harmed by bad products. That’s not the way that an efficient, science-based enforcement strategy works. Rather, our strategy focuses on the most efficient way to get the most compliance with the law. Our strategy focuses on using the methods that get the best results – how do we get the most bang for the buck in terms of improving the public health.

There are some key principles in our science-based enforcement strategy. First, clarity: use clear and consistent guidance and communication with regulated firms to promote voluntary compliance with the law. Many businesses are willing to do the right thing, but in areas as complex as food and medical production with products that are constantly changing, it can be challenging. Second, science: make sure that our practices reflect, and allow for, the latest innovations in production, inspection, and enforcement techniques. Our regulations should be no more burdensome than necessary, and should encourage valuable innovation in foods and medical products. Third, leverage: work with partners, including other Federal and state agencies as well as private oversight organizations, to bring more resources and a more coordinated, powerful approach to enforcement. Fourth, deterrence: since the other steps don’t always work, seek out bad actors aggressively, and punish them using the most effective tools available, including enforcement actions and criminal prosecutions that will stand up in court.

I’d like to tell you a little more about each of these strategies.

Promoting Compliance

By working to help businesses understand our statutes and regulations – especially the large number of small food producers and distributors, and the growing number of startup companies involved in biotech products and devices, all of which are facing an increasingly complex array of regulatory requirements – we can improve compliance with the law. We don’t have the luxury of enough resources to play “gotcha.” Instead, clarity and effective communication can get more companies into compliance at a low cost. So we’re stepping up our efforts to issue clear compliance guidances to industry, to provide opportunities for communication, and to sponsor more educational programs. We want to make sure everyone knows how to comply with rules designed to protect consumers and patients.

Latest Regulatory Science

We’re also working to make sure that all of our decisions are based on the most up-to-date, best science possible. One place is in our efforts to update and improve our regulations governing the manufacturing of all of the medicines that we regulate, from veterinary and human drugs, to biologicals, to vaccines. These regulations haven’t been updated in a quarter of a century.

During that time, manufacturing in many other industries with little tolerance for impurities or imprecision, such as the semiconductor industry, has changed fundamentally. With the adoption of so-called “six sigma” and “continuous quality improvement” techniques, the cost of manufacturing semiconductors has come way down, and purity and precision of semiconductors have improved. The same is true in many other high-tech industries. But even though most experts believe such techniques could have great benefits for reducing costs while assuring safety in the medical field, manufacturing methods for many drugs haven’t changed that much. Our broad-based regulatory reform is designed not only to make sure our regulations aren’t standing in the way, but that we are encouraging the adoption of the best available manufacturing techniques and technology to improve safety and purity. The new standards are also being designed to ensure that FDA uses consistent and up-to-date methods, including inspectors specializing in particular types of production methods.

Leveraging Relationships with Partners

To help meet increasing demands, we’ve also looked for better ways to leverage our relationships with partners. We’re working closely with the Federal Trade Commission under a liaison agreement that coordinates FDA’s authority over claims on product labeling and FTC’s authority over advertising claims. Another ongoing collaboration between the FDA and the FTC is “Operation Cure All, an ongoing law enforcement and consumer education campaign against the fraudulent marketing of supplements and other health products on the Internet.

The FDA also works with the Bureau of Customs and Border Protection to address safety issues with the growing number of imports. We’re working closely with the States on such issues as inspections and testing, illegal pharmacies, and counterfeit drugs; with the Inspector General to address kickbacks and other fraudulent and abusive practices that increase health care costs, including in improper drug promotion activities; with the Drug Enforcement Administration to address the growing problem of prescription drug abuse; and with the SEC to address misleading statements made by publicly held medical product firms. We’re currently close to finalizing a formal relationship with the SEC. And while this is happening, we are making referrals to the SEC when we see companies misrepresenting our discussions with them to the public markets. We really appreciate these valuable partnerships. They enable us to get the maximum impact and reach from our limited resources.

Deterrence through Enforcement

In cases where we can’t achieve full compliance through better guidance, better science, and better partnerships, we’re bringing tougher enforcement actions that will stand up in court. We’re seeking the maximum allowable penalties to set a clear deterrent for illegal behavior, particularly in areas related to the most serious threats to public health. Our most decisive enforcement tools remain those actions that remove products from the market and that bring criminal charges against people who threaten the public. And these actions have increased the most. Data from fiscal years 1998 to 2002 show that injunctions rose from 11 to 15, arrests went from 250 to 286; and convictions went from 194 to 317.

Often, our enforcement work invokes meaningful civil penalties. For example, in April, in an unprecedented action, FDA announced that the American Red Cross had agreed to substantial revisions in its consent decree with the FDA. For the first time, the revised consent decree includes financial penalties if, in the future, ARC fails to comply with FDA laws and regulations that are aimed at ensuring the safety of the nation's blood supply. The new financial penalties provide a strong incentive for the Red Cross to follow through needed improvements in its management culture, as its new leadership desires. In addition, we enjoined one company for its failure to comply with our Good Manufacturing Practice regulations and as a part of the settlement agreement the company agreed to pay $500 millions to the U.S. Treasury. The company also agreed to future payments up to $175 million and to give up additional profits if it fails to adhere to the timelines established in the settlement agreement.

On the criminal side, I’m pleased to be able to report that FDA’s aggressive investigations have recently led to a noteworthy string of record-breaking penalties against medical product manufacturers. This work, often jointly with other Federal agencies, has resulted in sizable penalties that add up to much more than the cost of doing business. In recent months, these include an $879 million settlement for conspiracy to commit violations of the Prescription Drug Marketing Act, a $355 million settlement for health care fraud, and $92 million for failing to report malfunctions of a medical device to the FDA.

FDA’s Office of Criminal Investigations is more active than ever. Just this week, based on their work, the Justice Department announced the guilty plea of a man who, our investigators found, was distributing controlled substances through an Internet drug site. FDA has brought many such cases this year, usually in conjunction with Federal and State law enforcement officials.

Our increasing willingness to pursue court action and criminal penalties is intended to send a clear message to those who would go so far as to threaten the health of the public to make a buck: we will come after you, and we will get you.

Examples of our Enforcement Strategies at Work

The principles that I’ve laid out are reflected throughout our enforcement work. And as I’ve said, we’re applying this enforcement strategy to protect against new and more sophisticated threats to the ability of Americans to have confidence in the products that they use to improve their health. There are many challenges to our mission, and I don’t have time to talk about all of them today. I would like to tell you about how we are responding to three serious, growing threats: counterfeit medications, the potential for deliberate contamination to our food or medicine supply, and false claims about the health effects of products that can mislead the growing number of Americans who are trying their best to improve their health.

Counterfeit Drugs

The 21st century has brought with it many valuable new medical technologies and the Internet. But with these new technologies the problem of counterfeit drugs has increased sharply. FDA has seen its counterfeit drug investigations increase to more than 20 per year since 2000, after averaging only about 5 per year through the late 1990s. Once a rare event, we are increasingly seeing large supplies of counterfeit versions of finished drugs being manufactured and distributed by well funded and elaborately organized criminal networks. What accounts for this sharp increase in counterfeiting activity? -- For one thing, greed. Criminal elements are lining up to take advantage of the growing spending on prescription drugs. As one of our criminal investigators put it: If Willie Sutton were alive today, he’d be peddling fake Viagra. Fake drugs are where the money is. It’s a multibillion-dollar global industry that accounts for the majority of drugs in many nations, and that is increasingly reaching into the United States.

Drug manufacturing and the drug distribution system have become more complex, and technologies for faking products and packaging have gotten much better. With more imports and the connectivity of the Internet, there are increased opportunities to introduce counterfeit and adulterated drugs into our drug supply.

We are seeing a variety of fake drug schemes. Some fake drugs contain ingredients that, if ingested or injected, can cause health problems. Recently, criminals counterfeited Procrit, an important drug for cancer and AIDS patients. This knock-off didn’t contain the drug; it contained non-sterile tap water. It was worse than nothing at all, since the dirty water could easily cause an infection in the bloodstream. Other counterfeits substitute one drug for another. In one case Insulin was swapped for a more expensive injectable drug. Some fake drugs contain some active ingredient, but are sub-potent. Others attempt to copy the real drug, but still pose safety risks because they are not formulated in a way that achieves the right therapeutic levels in patients. And some counterfeit drugs have no active ingredients at all.

We’ve been taking more aggressive and systematic actions to protect our drug supply from the influx of counterfeits, and we’re increasingly working as part of a concerted, coordinated program involving many federal agencies. Counterfeiters are getting tougher and more clever, and so are we. We’ve opened 73 different counterfeit drug investigations from October 1996 through June 2003, with most having begun in the last two-and-a-half years.

But we need to do more than react; we need to prevent and mitigate the threat by making our drug supply more secure and by improving our ability to detect and respond. Three weeks ago, I set up a new Counterfeit Drug Task Force to come up with a plan to do just that. It’s designed to better identify the risks, coordinate the public and private crime fighting efforts, and identify technologies and strategies to aid in identifying, deterring, and combating counterfeiting. With help from drug distributors, pharmacists, our allies in law enforcement, as well as consumers and health professionals, our goal is to arm ourselves with 21st century technology and tools that will allow us to match the sophistication of the counterfeiters that we’re up against.

In addition to our plan to call on better technology to thwart counterfeiters, we’re also deploying better methods to catch them. Here again, we’re looking to leverage the good work of other federal, state, and international agencies. In conjunction with the U.S. Bureau of Customs and Border Protection, our Counterfeit Drug Task Force is surveying drugs entering the U.S. at several major ports of entry, to get a better inventory of the type and extent of drugs arriving from overseas and the degree to which adulterated and potentially unsafe drugs are among such imports. The Task Force will also seek to improve upon the existing alert systems to improve our ability to put people on notice almost immediately when we find that a known or suspected counterfeit product has entered the drug supply chain. We’ll also be identifying ways to strengthen the distribution system, including the security of imported drugs. In every one of these initiatives, our goal is the same -- to increase consumer protections through the most effective and efficient means possible.

Health Claims and Consumer Information

More than ever, patients are playing a major role in their own health and medical care. The biggest difference we can make in improving the health of the public is by empowering people in the many choices they make every day that affect their health. My own experience as a physician and the experience of many of my colleagues all tell me that people want accurate, up to date, science-based information that they can trust to make smart decisions when it comes to choosing products that may affect their health. Better information means better educated consumers, consumers who are empowered to choose and use the right medical products and food products to best improve their health. And empowered consumers mean better competition: companies will be rewarded if they make healthier products, products that do more to truly help consumers.

And so, we’re going to be working harder than ever to make sure that the information consumers receive is scientifically valid and straightforward. I consider it a public health hazard when people are misled by false claims into wasting time and money on treatments that deliver nothing but false hope, when we know more than ever before about foods and drugs and other consumer products that actually work.

As you know, there’s also been a big increase in the amount of advertising to consumers that tells them about products that may affect their health. Studies have shown that consumers pay attention to ads with health claims, and that such ads can be effective vehicle for informing patients with undertreated diseases like high cholesterol and depression to take effective steps to improve their health, like seeing a doctor. But while ads may do a lot of good, we need to make sure that consumers aren’t being misled or deceived by promotional activity that violates the law.

To help make sure that these ads are providing a public health benefit, that they are not misleading or deceptive, the FDA alerts and sometimes takes further actions against sponsors whose ads violate our requirements, by overstating the effectiveness of a product or suggesting a broader range of conditions than the drug was approved for.

For example, we recently warned the manufacturer of one drug that some of their ads for physicians were misleading, and we demanded that they run new ads in about 30 medical journals to correct the misleading perceptions. And I want to announce that we just sent out a warning letter to the manufacturer of a widely-used cholesterol medicine, for making claims that the drug was useful in a broader range of conditions than we have evidence showing that it is in fact safe and effective, and for implying that the drug is the only product useful in some conditions. Here again, we asked them to immediately stop running the misleading ads and immediately start running new ads that corrected the false perceptions left by their original promotions.

But we don’t just want to play “whack-a-mole” with ads. To deter misleading ads in the first place, to provide a clearer basis for enforcement activities, and to help make sure patients get an accurate picture of the risks and benefits of a drug, we need to provide clear guidance based on the latest evidence on what works best for communicating accurate information to the public. FDA expects to issue new guidance on communicating risk and benefit information in direct to consumer ads later this year. This fall, we’ll be holding a conference and inviting in experts on DTC as well as the general public to make sure that our policies and guidance reflect the latest and best knowledge. And for the companies that don’t follow the rules, we are building a stronger record through letters that will stand up in court.

Although advertising has a high profile, it’s also important to recognizing that the way drugs are being promoted is changing. Advertising is not the main way that drugs are promoted these days. The bulk of spending on drug promotion goes to so-called “detailing” and educational activities for physicians, including new avenues such as e-detailing conducted by Internet videoconferencing. Companies spent $2.8 billion in 2001 on DTC ads versus $4.7 billion on doctor detailing and over $2 billion on educational events aimed at physicians. And doctors gave patients $10 billion worth of free samples.

Unquestionably, these activities help give doctors valuable new information about drugs, and help patients find out if a new product is right for them. But because some of these activities may also involve misleading activities or even criminal kickbacks, we’re exploring new ways to enforce the law in these new areas. We’ll probably have more to say soon on our support for some of the recently-announced activities of the Office of the Inspector General in this area. This may include help with guidance on what the lines are between appropriate and illegal detailing, and help to make sure that tough penalties will be enforced when companies cross those lines.

Dietary supplements are another area where the FDA has been encouraging the industry to improve its promotion. Most Americans use an increasingly diverse range of dietary supplements, including vitamins, minerals, herbal products, and nutrition bars, and we have seen a proliferation of advertising with a profusion of dubious claims in this area. This is a public health threat: we are asking people more than ever to take steps to improve their own health, and with supplements as with other products, we don’t want them to waste their time and effort.

So we’re also focusing even greater enforcement resources to clean up the shady claims that have found their way onto dietary supplement labels. Already this year, we’ve issued more than three times as many warning letters to halt dietary supplement manufacturers from making bogus health claims than in all of 2002. We’ve seized products that falsely claimed to cure diseases, and we’ve overseen the destruction of products that were wrongly using an old article from the New England Journal of Medicine to claim a health benefit. And as we are completing the required legal process that may lead to further regulation of ephedra, we’ve already removed from the market essentially all of the ephedra products that were claiming to improve sports performance – there is no clear scientific evidence that ephedra leads to any significant performance benefit.

The bottom line is the same, whether you’re dealing with a vital heart medication or a vitamin pack: We are working hard to create a marketplace with truthful, non-misleading, useful information about the health consequences of products – to empower consumers and to encourage better and healthier and more affordable foods, medicines, and supplements.

Food security

In the past, in fulfilling our mission of making sure that foods are safe, we used to worry about protecting Americans from what can go wrong. Since 9-11, we are increasingly focusing on weak points from the standpoint of food security – ways in which terrorists or others might deliberately harm us. In the fall of 2002, three individuals were arrested in Jerusalem for allegedly planning to carry out a mass poisoning of patrons at a local café. In January 2003, several individuals were arrested in Britain for plotting to add ricin to the food supply on a British military base. Each of these incidents shows the potential for a nation's food supply to be used as a vehicle for a terrorist attack. Here in the US, there has been intelligence regarding threats to the food supply that are guiding our efforts on these enforcement issues. And in response, we are implementing steps to improve food security that amount to the most fundamental enhancements in our food safety activities in many years.

These changes were laid out in the food security report that we released three weeks ago. Entitled “Ensuring the Safety and Security of the Nation’s Food Supply,” this report is a down payment on our efforts to help protect the nation’s food supply. It details the progress we are making. This includes issuing new guidances on how everyone involved in putting food on the plate, ranging from the largest manufacturers to the smallest mom and pop restaurant, can take affordable common-sense steps to prevent deliberate harm through food. It includes conducting a new type of research, food security research, to help us find ways to detect select agents and prevent harm from them if they make it into our foods. It includes new partnerships, including with the Department of Homeland Security, the States, and foreign governments. And it includes greater vigilance: for example, in this fiscal year, we’ve already conducted examinations of over 60,000 food imports, more than five times as many as last year. And later this year, we will implement major new regulations to improve our surveillance of food imports as well as our ability to identify and contain food borne outbreaks. By implementing our food security strategy in a way that builds on our food safety activities, we are also enhancing inspections, lab studies, surveillance, and food tracking capabilities – all of which improves our ability to keep the food supply safe as well.

Conclusion

I’ve tried to highlight some of the areas where we are working hard to keep FDA’s first priority of protecting the public up to date. There are many other areas where we are also doing more: preventing prescription drug diversion, especially involving drugs of abuse; working harder to prevent importation of potentially unsafe drugs, those that are improperly labeled and stored as well as those that are counterfeit; acting against unlawful FDA-regulated products sold over the Internet; bolstering the Federal government’s efforts to prevent emerging infectious disease threats like monkey pox and mad cow disease. These are real challenges for all of us, but these challenges, and many others, also explain why it’s such a privilege to be working at FDA today. And in all of these areas, there is much the public can do to help protect themselves and to help protect Americans – especially if they are well informed. And of course, the press can help too.

As criminals use more sophisticated means to commit more sinister crimes, and as the public health threats we face continue to evolve, one thing remains the same at FDA: we will continue to ensure that we are bringing to bear the best tools, methods, and personnel to keep Americans safe and secure. Day and night, here at home and around the world, the FDA is on the job.