Protecting Consumers from Bad Medicine

Courtesy of Acting Associate Attorney General Stuart F. Delery

Yesterday, I had the pleasure of joining the State Department and the Center for Safe Internet Pharmacies (CSIP) to discuss the important work the Department of Justice is doing on issues of drug safety.

For the past three-and-a-half years, first as the head of the Civil Division and now as the department’s Acting Associate Attorney General, I have overseen much of the department’s work related to ensuring that the food that Americans eat and the medicines that we take are safe.  Adulterated or misbranded drugs represent an invisible hazard, and American consumers need our help to keep them safe.  Indeed, as we at the department pursue our core mission of protecting the public, we take drug safety no less seriously than any other risk to the American people. 

And experience has shown that illegitimate online pharmacies can create several types of dangers.  They may dispense the wrong drug – one that will not work for the patient’s needs – or drugs that contain harmful contaminants.  And even where the product is what a doctor has actually prescribed, it may lack the active ingredient, be expired or degraded by improper storage, or be delivered without dosage warnings or directions.  The U.S. Food and Drug Administration (FDA) has created a robust safety regime for good reason, and circumventing its process may result in serious harm, both to those directly affected and, by undermining confidence in the medical system, to the public at large.

That is why the enforcement work of the department and its partners, including those at the State Department and CSIP, is so important.  The department has held accountable a number of actors who have furnished drugs to consumers through illicit online pharmacies – from pharmacists who enable such operations to companies that deliver goods unlawfully.  We will continue to hold accountable those who violate federal law and put at risk the health and safety of American consumers.

The department’s prosecutions and enforcement actions help to educate consumers by bringing to light facts that illustrate the dangers that illegitimate online pharmacies pose.  When the protections provided by the FDA’s system are subverted and medication is adulterated or misbranded, patients may suffer real harm.

The investigation and prosecution of Canadian online pharmacy operator Andrew Strempler, whose company operated at RxNorth.com, provides just one example.  Strempler falsely represented that RxNorth was selling safe prescription drugs in compliance with regulations in Canada, the United Kingdom and the United States.  However, Strempler obtained the prescription drugs from various other source countries without properly ensuring the safety or authenticity of the drugs, and in fact, some of the drugs sold by Strempler included counterfeit drugs. 

The department also prosecuted Richard Taylor, an English citizen who pleaded guilty to distributing adulterated prescription drugs used for cancer treatment.  To be safe and effective, some of the prescription drugs distributed by Taylor needed to be shipped and stored at constant cold temperatures.  While distributing these prescription drugs, Taylor learned that multiple doctors in the United States had received shipments of “cold chain” cancer prescription drugs that were warm upon arrival and damaged during shipment, but still kept shipping adulterated drugs to the United States. 

Taylor was also involved in importing counterfeit Altuzan, an intravenous cancer treatment drug marketed in Turkey that contains the same active ingredient as the drug marketed in the United States as Avastin.  He was notified that an oncology nurse of a U.S. doctor reported that two patients had “immediate bad reactions” during infusions of the drug.  One of these 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.”  The nurse advised that she had been administering Avastin for years and never had a patient reaction like this before.   

The Department of Justice is committed to continuing to use all of the criminal and civil enforcement tools at our disposal to produce cases like these.  But enforcement alone is not the answer.  That is why I was so grateful for the chance to speak with our partners from the federal government and industry in this effort.  Engagement and dialogue between government and industry is critical, and collaboration with industry is a key component of the department’s efforts to prevent future incidents.  When the goal is ensuring that Americans can trust the prescription drugs they obtain online, government and industry are on the same side. 

In October, Attorney General Lynch announced the launch of the department’s new collaborative strategy to more closely partner with businesses in intellectual property enforcement efforts.  As part of the strategy, the FBI will partner with third-party marketplaces to ensure they have the right analytical tools and techniques to combat intellectual property concerns on their websites.  Furthermore, in an effort to mitigate instances of the manufacture, distribution, advertising, and sale of counterfeit products, including pharmaceutical drugs, the FBI will serve as a bridge between brand owners and third-party marketplaces.  The new strategy will enable law enforcement and companies to better identify, prioritize and disrupt the manufacturing, distribution, advertising and sale of counterfeit products.  Once crimes have been identified, they will be investigated by the FBI and other partners of the National Intellectual Property Rights Coordination Center and prosecuted by the Department of Justice. 

I’m confident that when the government and industry work together on this common cause, we can have a real impact on the health and safety of the American public.