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

FDA Cracks Down on Flu Product Scammers

By: Gary Coody, R.Ph.

The severity of this year’s flu season has brought out the scammers promoting fraudulent flu products.

Gary Coody, R.Ph., is FDA’s national health fraud coordinator, FDA Office of Regulatory Affairs, Office of EnforcementThrough our careful monitoring of the Internet, FDA has identified numerous untested and unapproved products being illegally marketed with deceptive claims that they prevent, treat, or cure the flu.

When FDA staff find these fraudulent products, we send a warning letter to the sellers describing how the product violates federal law and instructing them to respond in writing with a description of how they intend to address the violations. If a seller does not respond within 15 days and continues to sell the product without correcting the violations, the products being sold by U.S. companies may be seized, FDA may notify law enforcement officials in the country abroad where a seller maintains its operation, or the federal government may take other legal actions.

In the past week, the agency has sent nine warning letters to firms marketing fraudulent flu-fighting products, including an online seller marketing a product that claims to be an alternative to the flu vaccine, three firms marketing dietary supplements online (letters co-signed by the Federal Trade Commission), and a firm selling an oral spray online and in major retail stores.

The remaining four warning letters were issued to online firms selling what they claim to be generic and other unapproved versions of oseltamivir phosphate, the active ingredient in Tamiflu. Tamiflu is an FDA-approved brand-name drug, but no generic Tamiflu is approved in the U.S.

FDA advises consumers to beware of online “pharmacies” selling generic versions of Tamiflu. If you buy one of these products, you don’t know what you’re getting—it could be counterfeit, contaminated, or not stored properly to maintain quality. It could also have the wrong active ingredient or no active ingredient at all.

Some of the other fraudulent claims addressed in the warning letters include:

  • “the most effective alternative to the flu shot”
  • “natural health and strength can still be yours without flu shots”
  • “fight cold and flu – naturally!”
  • “safeguard you from deadly flu viruses.”

Our concern is that a consumer will buy or use a fraudulent product advertised as an “alternative to the flu vaccine” instead of getting the approved vaccine. The vaccine is the best way to prevent getting the flu.

Any time there is a large outbreak of disease, fraudulent products appear on the market. Bogus remedies were rampant during the 1918 flu pandemic, commonly known as the Spanish flu, which killed an estimated 675,000 Americans. Fast forward to 2009, when FDA sent out more than 100 warning letters to sellers fraudulently promoting their products to prevent the H1N1 (swine) flu.

Today, when a health threat emerges, fraudulent products appear almost overnight because the Internet and social media such as Facebook and Twitter have accelerated how quickly hucksters can reach the unsuspecting public.

FDA can’t track down all of these fraudulent products, so consumers need to beware of unapproved products that make false claims. When in doubt about a product, talk to your doctor, pharmacist, or other health care professional.

For more information about health fraud scams, visit www.fda.gov/healthfraud.

Gary Coody, R.Ph., is FDA’s national health fraud coordinator, FDA Office of Regulatory Affairs, Office of Enforcement