FDA’s Special Agents: On the Job to Protect the Public

By: John Roth

As noted in my previous three posts, FDA’s Office of Criminal Investigations (OCI) is an integral part of FDA’s mission to protect the public’s health. Our top-flight special agents –who have investigative authority similar to other federal law enforcement agencies – give the FDA unique fact-finding tools and provide for strong, industry-wide deterrence. Their work is different from, but enhances, the regulatory inspectors and investigators that make up the bulk of FDA’s field operations. 

Who are these special agents? They are federal law enforcement officers and they have experience: our average agent has been in federal law enforcement for over ten years, a necessary requirement given the sophistication required to work the wide range of OCI cases. 

Each special agent undergoes specialized training to be effective in their job, including firearms and personal safety training, advanced Special Agent training, and training in FDA law.  Throughout their career, OCI agents will keep up to date on the latest trends by participating in what is called “in-service training.”  Additionally, agents will take specialized training in other areas of federal law enforcement, including cybercrime investigations, computer forensics, financial tracing/asset forfeiture investigation, polygraphy, leadership and management, and advanced law enforcement techniques.

As you can see from this training regimen, we demand a lot from our agents – these skill areas are exceedingly complex. Moreover, agents must also learn such intangible skills as being able to work well with others, remain alert and focused, and hone that age-old requirement for any law enforcement officer: good instincts and a devotion to old fashioned shoe-leather doggedness. 

Our agents are located in more than 37 offices nationwide, from Hawaii to Puerto Rico, and work with law enforcement counterparts in many countries, as well as international organizations like Interpol, Europol, and the Permanent Forum on International Pharmaceutical Crime. 

No agent can go it alone, of course, and we rely on an outstanding supporting cast to help us: our “can-do” support staff, who make running a complex nationwide law enforcement program look effortless, the unmatched scientific and public health experts in the FDA centers and the civil-side inspectors and compliance officers in the field, who we rely on for help with complex, scientific cases, and finally prosecutors in the Department of Justice, who have embraced the FDA public health mission. 

My three previous FDA Voice posts highlighted several of the more significant, colorful, and sometimes tragic cases with which OCI has been involved. The first post looked at how we use our top-flight federal agents to work undercover in investigating shadowy overseas drug counterfeiters. The second post looked at high-profile instances of non-compliance right here in the United States – with our work resulting in a $1.4 billion fine. The third post looked at the callous and utter disregard for life caused by corporate actors, which necessitated a criminal response. Yes, these cases involved detailed, complex organization and a range of professional skills. 

But let me emphasize: OCI is doing this work every day. In fact, about every 30 hours, throughout the year, we are gaining a conviction, in crimes ranging from street level pharmaceutical diversion schemes to corporate fraud. In Fiscal Year 2012, OCI agents were responsible for cases that yielded over $4.9 billion in fines and restitution – monies that are paid directly to the U.S. Government or to specific victims of the criminal acts we investigate – an average of over $22 million per special agent. 

FDA’s Office of Criminal Investigation is the only federal law enforcement agency whose mission is exclusively directed at protecting the public’s health. And, criminal enforcement is a critical part of FDA’s enforcement and compliance strategy, a strategy designed to protect people from dangerous products, fraudulent schemes, and unscrupulous criminals. 

Through these four FDA Voice posts, I hope that we have made our OCI team better known to our FDA colleagues and to the public. The vast majority of the FDA-regulated entities respond to FDA’s ordinary regulatory tools. However, OCI stands ready and on watch to locate, investigate, and bring to justice those individuals and entities who disregard and break our public health laws. 

John Roth is Director of FDA’s Office of Criminal Investigations

Counterfeit Drugs: Prosecuting the Profiteers, Protecting the Public Health

By: John Roth

On July 12, I was in Missoula, Montana when Paul Bottomley, 48, was sentenced as a result of his participation in the wholesale marketing of unapproved and misbranded cancer medications. Many Americans may not know Bottomley or his criminal activities. But his sentencing was another victory in FDA’s ongoing fight to safeguard Americans from misbranded, adulterated and counterfeit pharmaceuticals. This case is part of an agency-wide effort to ensure that consumers have access to high quality drugs – and that these medicines are traveling safely through increasingly complex supply chains.

Getting such predatory opportunists off the streets may be only a small part of what we do at the FDA’s Office of Criminal Investigations, but it is critical to protecting the public health. Our investigation found that Bottomley imported misbranded and unapproved cancer drugs from foreign countries – in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) – and sold those drugs to American physicians.

Bottomley is one of those people you hope never to meet. He sold unapproved and misbranded cancer drugs through Montana Health Care Solutions (MHCS), which began operating in 2008.  In 2010, Bottomley sold MHCS to Rockley Ventures, a subsidiary of Canada Drugs, Ltd.,, but remained associated with the company as a consultant.  After its sale to Rockley, MHCS began selling Avastin, a prescription drug that at the time cost nearly $2,300 a vial, approximately $600 more than what MHCS charged.  In 2011, the Food and Drug Administration learned from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) about a potential counterfeit oncology drug being marketed as Avastin. Our investigation led us ultimately to Bottomley, MHCS, and others.  Numerous physicians and the officials who operated their practices confirmed that the drugs they received came from MHCS.

Cancer patients in the United States count on certain drugs to treat their disease and often to keep them alive. Sadly, some of the Avastin sold by MHCS was counterfeit. In fact, when tested, the counterfeits did not contain any of the active drug ingredient bevacizumab that is found in legitimate versions of the drug. Tragically, not only did these patients pay a high price for a worthless drug, but they didn’t get the treatment they needed or expected.

But that is not all. In fact, one of the foreign sources of supply was Richard J. Taylor of Warwickshire, England. On July 11, 2012, Taylor was sentenced to 18 months in prison and a fine of $800,000 for distributing adulterated prescription drugs used for cancer treatment from the United Kingdom to multiple physicians in the United States. Like Bottomley, Taylor didn’t care about the law or the patients he was short-changing. He certainly knew what was happening to them. On May 10, 2011, Taylor was notified that two patients “who had been on Avastin for a while started to shake in the middle of being transfused and had to be disconnected from treatment.” A nurse advised that she had been administering such cancer drugs for years and had never seena patient react like this before.

Taylor and Bottomley both acted out of greed. In April, the U.S. Attorney for the District of Montana, Michael W. Cotter, made just that point, saying that Bottomley was motivated by nothing more: “Bottomley . . . sold potentially dangerous unapproved and misbranded pharmaceuticals at discounted prices to American physicians all for a healthy profit.”

All of us who work in enforcement at the FDA have seen this pattern too often – criminal offenders seeking to profit from distributing substandard or ineffective drugs that are ultimately administered to unsuspecting and vulnerable patients. So when people like Bottomley and Taylor are sentenced, we know this is a victory for all of us, especially those who are victimized by opportunists. OCI’s determined work continues to produce results. These prosecutions help deter others from such reprehensible conduct and from breaking the laws intended to protect us all.

FDA takes all reports of suspect counterfeits seriously and, in order to combat counterfeit medicines, is working with other agencies and the private sector to help protect the nation’s drug supply from the threat of counterfeits. Together, we are fighting a global battle, working with our regulatory counterparts throughout the world, utilizing new tools to safeguard the public health, and prosecuting those who seek to profit at the public’s expense.

John Roth is Director of FDA’s Office of Criminal Investigations

When Conduct Becomes a Crime

By: John Roth 

In my last post, I explained how FDA’s Office of Criminal Investigation (OCI) works when a small portion of the industry fails to adequately respond to regulatory action. For Abbott Laboratories and Amgen, the price for regulatory malfeasance was high:  $1.4 billion – yes, billion — paid in criminal and civil penalties to the United States. 

Sometimes, however, the conduct of entities evinces such a complete disregard for the health and safety of the public that a criminal response is necessary. 

A case that still resonates with the FDA and law enforcement community involves the OCI investigation of the conduct of Synthes, a medical device maker, in the marketing of a bone cement product called Norian XR. The product was cleared by FDA for use in certain instances, but was specifically rejected for the use Synthes wanted: injection into the spine as part of a mixture. 

In fact, the FDA-approved label specifically warned against such use. Rather than attempt to get FDA approval through scientifically-validated clinical trials (at a cost of about $1 million, and taking about three years), Synthes decided to convince doctors to perform the procedure and then publish the results, notwithstanding the risks. And certainly, Synthes had reasons to understand the risks. Before the marketing program began, pilot studies showed that the bone cement reacted chemically with human blood in a test tube to cause blood clots. The research also showed, in a pig, that such cement-caused clots became lodged in the lungs.  

Nevertheless, Synthes executives plunged forward with a plan to conduct what amounted to an unauthorized clinical trial of the use of Norian to treat vertebral compression fractures of the spine. Equally appalling, the company marketed uses of the product in contravention of a “Black Box” warning — the most serious warning the FDA can require. 

The ensuing tragedy was inevitable. Three patients injected with the medication died on the operating table. 

Despite this, the company did not recall the product from the market, an action which would have required them to disclose details of the three deaths to the FDA. Equally egregious, Synthes officials deliberately misled the FDA during an official inspection in May and June 2004. 

After painstaking and complex work by OCI investigators, working with their colleagues in FDA’s Office of Regulatory Affairs and the scientists and public health experts in FDA’s Center for Devices and Radiologic Health, in 2010, Synthes pled guilty and paid the maximum fine allowable by law — in excess of $23 million for the company and its corporate parent. In 2011, four executives were convicted and sentenced to prison terms. 

Another similarly tragic case of reckless conduct involved ApotheCure, a compounding pharmacy in Dallas that shipped colchicine injectable solution to a medical center in Portland, Oregon. Colchicine is used to prevent gout attacks and relieve the pain of gout attacks when they occur. In 2007, three patients, within hours of receiving the drug, died. 

FDA testing of vials selected from the shipment revealed some vials as super potent — containing over 640 percent of the level of the drug that was declared on the label. Others were sub potent, containing less than 63% of the declared strength. After an OCI investigation, the pharmacy and its owners pled guilty to criminal charges in 2012. 

The penalties imposed on these two firms, Synthes and ApotheCure, and the responsible individuals cannot bring back the lives of those six innocent individuals. But OCI’s determined work produces results, and as I noted in my first post, “gives the FDA unique fact-finding tools and provides for strong, industry-wide deterrence.” We trust our forceful actions, then and now, continue to deter other companies and individuals from such reprehensible conduct. 

John Roth is Director of FDA’s Office of Criminal Investigations

When Regulators are Ignored

By: John Roth

In my last FDA Voice post, I explained the Office of Criminal Investigation’s (OCI) role within FDA as using our top-flight federal agents to protect the public health in unique ways. Not every one of our cases involves undercover agents investigating shadowy overseas drug counterfeiters. Sometimes, illegal behavior leads us to high-profile instances of non-compliance right here in the United States.

Now, the good news is that the vast majority of the FDA-regulated entities respond to FDA’s ordinary regulatory tools. The concerning news, however, is that lapses in compliance do occur and the criminal remedy is available to gain compliance for that small portion of the industry that fails to respond to ordinary regulatory tools. 

Before selecting that remedy, OCI will look to see whether the entities have demonstrated a resistance to other regulatory efforts, including requests for voluntary cooperation and FDA formal warning letters or inspection reports, and instances in which entities fail to comply with judicial orders. We are particularly sensitive to circumstances in which it appears that the regulated entity engages in fraud or other deceptive conduct, either in relation to the FDA or the public at large.  

One area of particular OCI focus is the deceptive conduct by those who manufacture and market pharmaceuticals. It’s nothing less than a life-threatening problem for millions of Americans who rely upon safe medications. 

Moreover, it’s a category that has involved our OCI professionals in a number of fairly high-profile criminal prosecutions involving a range of criminal behavior. Take the investigation of Abbott Laboratories, for example. Abbott applied for FDA approval to use its drug Depakote for additional indications, including treating dementia and schizophrenia. Healthcare providers using the drug for approved uses were required to balance the potential benefits against the significant risks associated with the drug. Indeed, the drug carried three “Black Box” warnings — the most serious warning the FDA can require — as a result of the adverse side effects associated with the risk of the drug.  

The FDA denied the application because even after a number of clinical trials, Abbott could not demonstrate that Depakote was effective for the new indications. Notwithstanding the FDA rejection, Abbott trained its sales force to aggressively market Depakote for dementia and schizophrenia, claiming advantages over several competing products, and failing to disclose the previous negative studies. Moreover, after two of Abbott’s own studies failed to show that Depakote was effective in treating patients with dementia and schizophrenia, Abbott waited nearly two years to notify its own sales force about the study results and another two years to publish those results. Abbott ultimately pleaded guilty and paid $700 million to the U.S. in fines and forfeitures.  

A similar fact pattern occurred in the investigation into the biotechnology company Amgen. In that case, the manufacturer sought FDA approval for additional indications for its anemia drug Aranesp. The company wanted to add patients with chronic kidney disease or those receiving much larger, less frequent, doses of chemotherapy than those currently approved by the FDA for these patient populations. FDA rejected the application after determining that Amgen had failed to show that Aranesp was safe and effective for these expanded indications. 

Despite that decision, Amgen aggressively marketed the drug as more effective than its FDA-approved competitor for the unapproved indications. Amazingly, the Amgen sales force was trained to provide physicians with studies to demonstrate Aranesp’s effectiveness — studies that the FDA itself had rejected as insufficient to support the safety and efficacy of the drug for those off-label uses. And in fact, for one of the off-label uses — the treatment of anemia caused by cancer, irrespective of whether the patient had undergone chemotherapy — the FDA later determined that its use caused an increased risk of death and issued a “Black Box” warning on the drug for that use. Amgen ultimately agreed to pay the U.S. over $700 million in criminal and civil penalties to resolve these claims. 

In the next post, I’ll detail another aspect of OCI’s work. In the meantime, consider the nearly $1.4 billion in fines against these two firms – it’s an outcome that underscores the severity of the public health challenge and what happens when regulators are ignored. 

John Roth is Director of FDA’s Office of Criminal Investigations

FDA’s Criminal Enforcement Priorities Protecting Public Health

By: John Roth

Although perhaps not widely known, FDA’s Office of Criminal Investigations (OCI) is an integral part of FDA’s mission to protect the public’s health.  FDA’s team of top-flight federal agents – who have the same type of arrest authority as other federal law enforcement agents – gives the FDA unique fact-finding tools and provides for strong, industry-wide deterrence. Their work is different from, but enhances, the regulatory work typically conducted by inspectors and investigators that makes up the bulk of FDA’s field operations.

OCI focuses its efforts on threats to the public health in four areas: we investigate criminals who can’t be reached by the rest of FDA, particularly in the area of counterfeit and unapproved medical products; we move against public health problems when our ordinary regulatory tools aren’t the best option; we seek criminal penalties against conduct in which the harm to the public is so grievous that a criminal response is appropriate; and we investigate lying to the FDA and other behavior that deprives the FDA of its ability to regulate. We have a variety of tools at our disposal to accomplish our mission, including felony charges under the Federal Food, Drug, and Cosmetic Act, misdemeanor prosecutions of responsible corporate officers, and prosecutions for fraud, money laundering and obstruction of justice.

It’s a big job.  FDA regulation affects more than 20 cents of every consumer dollar spent on products in the U.S. And the fact is, some conduct by individuals and entities is beyond the reach of FDA’s typical administrative and civil enforcement tools. This conduct includes rogue internet pharmacies, purveyors in grey and black market unapproved medicines, and counterfeiters, both in the United States and overseas. Individuals intent on defrauding an unsuspecting public are often part of a larger organized criminal enterprise and don’t respond to the normal FDA regulatory process. They are engaged in a crime, and as a result the FDA treats it as a crime, and that’s where OCI steps in. 

The case of Shengyang Zhou is a good example. In January 2010, the FDA became aware of counterfeit versions of the popular weight loss drug Alli being distributed in the United States, and warned consumers about its dangers. The counterfeit product had entered the legitimate supply chain lacking the active ingredient contained in the genuine Alli and, especially alarming, contained undeclared amounts of the drug sibutramine, which is no longer sold in the United States because of concerns over its association with increased heart attacks and strokes. OCI agents had initiated a criminal investigation after intercepting unapproved dietary supplements laced with sibutramine and phenolphthalein that had been shipped from China to an individual in Colorado. This seizure ultimately led to OCI agents developing an undercover operation against a Chinese counterfeiter, Shengyang “Tom” Zhou. Posing as buyers, OCI Special Agents met with Zhou in Bangkok and negotiated a sale of counterfeit drugs to be shipped to the United States. During the undercover operation, Zhou bragged that he had a factory in southwest China that could make thousands of boxes of weight-loss products per day. Zhou was ultimately arrested, pled guilty, and was sentenced to 87 months’ imprisonment.  Evidence presented at Zhou’s sentencing included a physician who had unsuspectingly taken the counterfeit Alli and suffered a stroke.

Admittedly, not all our work is this interesting and dramatic. But this is a good example of the truly remarkable skills – from technological and scientific, to the intangible personal skills of working undercover overseas – that our agents bring to the task. In a future blog, I’ll explain our work when ordinary regulation is insufficient and when we move against people who lie to the FDA, which prevents the Agency from doing its regulatory job. Some may not be as colorful as the example above – but all will show the key role of OCI in furthering the FDA mission in protecting the public health. 

John Roth is the Director of FDA’s Office of Criminal Investigations