Counterfeit Drugs: Prosecuting the Profiteers, Protecting the Public Health

Counterfeit Drugs: Prosecuting the Profiteers, Protecting the Public Health
Posted on July 15, 2013 by FDA Voice

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 2010, 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.

http://blogs.fda.gov/fdavoice/index.php/2013/07/counterfeit-drugs-prosecuting-the-profiteers-protecting-the-public-health/