Good morning and thank you, Cindy, for that kind introduction. And thank you to all of you for being here. In my brief remarks this morning, I would like to describe for you some of what the Justice Department will focus on in 2013 and share with you some of the considerations that will guide us in upcoming enforcement actions. We know that all of you take seriously the responsibility to ensure compliance throughout your organizations, and I hope that my reflections on our recent work will help you as you continue to craft and refine your compliance programs.
Let me begin by way of background. I lead the Consumer Protection Branch of the Civil Division of the Department of Justice, and the mission of the Consumer Protection Branch is simply to protect consumers. We do so through the prosecution and litigation of both civil and criminal matters in the areas of food, drugs, consumer goods, services, and financial fraud.
For context, although we work in a number of areas, we probably work most with the FDA. A close second is our growing practice in financial fraud. Some of you are familiar with our Branch because together with the United States Attorneys’ Offices, we have brought many of the largest health care fraud cases against pharmaceutical companies—such as those involving Abbott, GSK, and Merck.
Now while we work with a number of statutes and a number of different agencies, we do not see our work as a list of statutes to enforce or collection of areas of law in which we practice. Rather, our focus is on the mission of protecting consumers, and our highest priority is to protect consumers where they are most vulnerable—where the harm to consumers is widespread and substantial or where consumers are at greatest risk of harm.
So when CBI asked me to address our top areas of focus for the Department this year, drug safety immediately came to mind, and within drug safety, the illegal conduct that came to mind was misbranding and adulteration of drugs. In the area of misbranding, when companies make promotional claims that are not truthful and balanced, or when they do not disclose all relevant safety information to FDA and doctors, they place patients at great risk of harm because neither doctors nor patients can make informed choices about their drugs.
Similarly, when companies fail to follow current good manufacturing practices, they often place patients at great risk of harm that neither they nor their doctors have any way of mitigating or even recognizing.
We are very concerned any time it appears that a company is gambling with patient health for monetary gain, and you will see this concern in many of our recent misbranding prosecutions.
For example, in the Merck resolution in 2012, not only was Merck prosecuted for misbranding the pain reliever Vioxx by promoting it for rheumatoid arthritis before that use was approved by the FDA, but as alleged in the civil settlement agreement, Merck made inaccurate, unsupported, and misleading statements about Vioxx’s cardiovascular safety in order to increase sales of the drug, resulting in payments by the federal government. As you know, Vioxx was ultimately withdrawn from the market because of its cardiovascular risks to patients.
Similarly, in the Abbott resolution of last year, some of the most troubling conduct at issue was the company’s promotion of Depakote to treat a vulnerable patient population—elderly nursing home residents—for the control of agitation and aggression despite the absence of credible scientific evidence that Depakote was safe and effective for that use. The company also marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia, even after clinical trials failed to demonstrate that adding Depakote was any more effective than an atypical antipsychotic alone for that use.
Finally, both the Avandia charge and the Paxil charge in the recent GSK resolution expressly pertained to safety issues. In the Avandia prosecution, GSK failed to include certain safety data about Avandia, a diabetes drug, in its reports to the FDA. These reports were specifically intended to allow the FDA to determine if the drug continued to be safe for its approved indications and to spot drug safety trends. The missing information included data regarding certain post-marketing studies, as well as data regarding two studies undertaken in response to European regulators’ concerns about the cardiovascular safety of Avandia. Since 2007, the FDA has added two black box warnings to the Avandia label to alert physicians about the potential increased risk of congestive heart failure and heart attacks in patients taking Avandia.
In the Paxil part of the case, GSK promoted Paxil to doctors for the treatment of depression in patients under age 18, even though FDA had never approved Paxil for pediatric use. Among other things, GSK participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy. At the same time, it did not make available data from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18. Since 2004, Paxil, like other antidepressants, has included on its label a “black box warning” stating that antidepressants may increase the risk of suicidal thinking and behavior in short-term studies in patients under age 18, clearly a major safety concern.
Each of these cases involved, to one degree or another, a company making misrepresentations regarding safety and placing patients at an unacceptably high risk of harm in the service of the bottom line. You will likely continue to see this as a theme of our Food, Drug, and Cosmetic Act prosecutions, and you should know that we will be taking an especially hard look whenever there are misrepresentations of safety.
We will also be taking an especially hard look whenever patients are placed at an unacceptably high risk of harm by those violations of current good manufacturing practices. As you know, the GMP regulations are designed to assure that drugs meet safety, identity, and strength requirements and that they meet the quality and purity characteristics which they are represented to possess.
We appreciate that achieving GMP compliance is not easy given that safety is not a simple black and white issue. Rather, it is a continuous process of assessing and eliminating or minimizing risks.
But the GMP regime is intended to guide you and your organizations in calibrating those risks. Because it helps the industry to strike the appropriate balance between ensuring adequate safeguards for drug safety and optimizing efficiency in light of the dictates of science and the marketplace, companies disregard this regime at their peril and that of millions of Americans. We know, of course, that there are enormous pressures on all parts of the industry to produce drugs more quickly, cheaply, and efficiently, and our message to you is that you cannot sacrifice drug safety in service of these pressures. We also know that many of you have implemented strong compliance programs to detect and provide early warnings before misconduct develops into a criminal violation, and our enforcement priorities and approach are intended to recognize that in a meaningful way.
Now that you know that GMP will be one of our top areas of focus, many of you want to know the answer to a simple question: What is the DOJ looking for? How can I avoid ever having to deal with this woman or the US Attorneys on the panel after her?
Let me offer these thoughts. In addition to focusing on plants and production lines and manuals and policies and testing and controls, I urge you to also focus on people. People are at the heart of what you do, and it is the failures of people—often the combined failures of a number of people—which result in noncompliance. Therefore, in our investigations, we are looking at people to determine responsibility. And for this same reason, we urge you to look at people.
And if you are going to focus on people, here are a few questions you may want to use to guide this focus:
1. Do we have the right people?
You need people with the right training and expertise to recognize problems that can arise when manufacturing pharmaceuticals. People are not fungible, especially when it comes to the complex and highly technical issues that arise in a pharmaceutical production line. For instance, in our recent civil resolution with Genzyme to resolve a number of GMP violations at their Massachusetts facility, one issue was failure to use equipment constructed so that the surfaces contacting drugs or drug components were not reactive, additive, or absorptive. Clearly, you need the right people to recognize such a risk and ensure that the right equipment is used.
2. Do our people have the right incentives to see problems, to report problems, and to fix problems?
We sometimes see in our cases that individuals in companies cut corners in order to meet production goals or to cut costs. You want to make sure that there are strong incentives that go the other way, incentives for people to see problems, report problems, and fix problems. Internal communication—and systems to encourage that communication—are key. One thing that is notable in many of our recent GMP resolutions, for instance, the civil consent decree against Ranbaxy, is that the investigation followed numerous early red flags within the company and warning letters from the FDA that were never adequately addressed. You want to ensure that the system of formal and informal incentives within your company compel and encourage prompt and fulsome responses to issues that arise.
3. Are our people satisfied and engaged?
Our investigations have revealed that often the departure of key employees can be a crucial turning point for an organization. It can be a red flag of existing problems or of problems to come, particularly if departures leave a vacuum in key positions or leave remaining employees overwhelmed and unable to meet the dictates of safety. For example, in the Cidra case in which SB Pharmco, a GSK subsidiary, was prosecuted for GMP violations at its plant in Cidra, Puerto Rico, the departure of certain key employees with responsibility for drug safety led to many of the conduct supporting the criminal charges. We all know that having a reputation as being fair and honest can enhance employee morale and aid in recruiting and retaining the best and brightest employees, and this can be critical in maintaining a seamless and airtight culture of compliance.
4. Are our people and policies working in harmony? Put another way, do our policies acknowledge how real people work and what they are capable of?
Quality assurance processes that rely on unrealistic expectations are doomed to fail. Using the Cidra example again, some of the safety problems resulted from relying on a policy of 100% visual inspection of certain tablets when visual inspection could not actually reveal problems given the speed of the production line.
5. And finally, one of the most important people to focus on is each of you. So the final question should be do we personally have visibility into what our people are actually doing?
As you know, avoiding knowledge of problems in your organization will not shield you from liability. Many companies are increasingly doing independent audits or bringing experts in to examine their compliance in a rigorous way. This is one way to make sure that your systems are not masking any problems that exist, and we encourage you to consider this approach.
Let me conclude with this. The GMP regime as we see it presents a great opportunity for partnership and cooperation between government and industry, especially when we are dealing with critical drugs. Not only does the statute explicitly look to companies to determine the appropriate balance in the first instance, thereby making you partners with government, but also strong enforcement protects those companies that do follow the rules. Weak enforcement that encourages deviations from GMP and noncompliance in this area affects the entire industry, as it erodes the confidence of the American public in our drug system. In a day and age where consumers are increasingly looking outside the regulated drug delivery system for their medication, such as to illegal online pharmacies, it is important that we maintain the rigorous standards we have in the regulated system. And when companies put profits over safety, nobody wins—not the patients, not the consuming public who loses faith in the safety of the drugs all of you produce, and not those of you who are playing by the rules and cutting into profit margins to do it. And this collaboration is already underway; I would venture to say that because of it we are seeing many positive trends in pharmaceutical compliance.
We encourage you to continue to think creatively about how to create a deep and effective culture of compliance within your organizations.
Thank you again for your interest in the work of the Department and your commitment to ensuring that the US drug supply continues to be one of the safest in the world.