Defendant pleaded guilty to purchasing diverted prescription drugs on the black market, then reselling them into legitimacy via Altec Inc.

William D. Rodriguez, of Miami Florida, was sentenced today to 120 months in prison for his role in a complicated drug diversion scam, reports the US Department of Justice. Rodriguez’ illicit business purchased prescription drugs from all manner of sources, such as cargo thefts and patients willing to sell their medication, then repackaged the drugs and created a drug “pedigree” for them before selling them back to consumers. He was also found guilty of money laundering, and was ordered to forfeit $55 million in profits.

For older consumers joining the ranks of Internet users, purchasing prescription drugs online presents opportunities for saving, but also dangers from fake online pharmacies.

A recent survey by Pew reports that 70% of Internet users 65 and older are online daily.  A joint study by The Optum Institute and Harris Research discovered that 57% of Internet users over 65 are interested in communicating about their healthcare via the Internet. As more seniors begin looking for healthcare solutions online, including finding medical information and seeking out prescription medications, they are unlikely to easily distinguish verified and authentic pharmacies and health information from fake online pharmacies where counterfeit drug criminals are eager to prey upon them.

The following guest blog is provided by Elizabeth A. Gallenagh, Esq., Vice President,
Government Affairs and General Counsel of the Healthcare Distribution
Management Association (HDMA), a PSM member.

The opinions expressed are not necessarily PSM’s policy.

The
U.S. healthcare supply chain remains one of the strongest in the world, but it
is not immune to bad actors and incidents that compromise patient safety and
security. For example, in the past year alone we have seen major headlines of
counterfeit Avastin reaching patients and “gray market” profiteers.

August 2012 found The Partnership For Safe Medicine’s Executive Director Scott LaGanga meeting with Chinese government and business authorities in Beijing to discuss counterfeit medications.

The timing of the visit coincided with a government seizure of $180 million worth of counterfeit medications said LaGanga, noting that there is still much to be done to curb counterfeit drug production in China. “While a critical development, our work is only getting started and it will take the public-private partnership of government, industry, stakeholders and individual patients before we can make a dent in this issue,” wrote LaGanga in a blog post.

Robin Han, a citizen of New Zealand, faces up to 30 years in prison and possible $6 million fine after pleading guilty to counterfeit drug charges last month.

US attorneys from the Central District of California have successfully prosecuted Han on charges he was a large scale trafficker of counterfeit drugs in the United States. His indictment was originally filed in 2007, but he was a fugitive from justice until March 29th of this year, when he was taken into custody at San Francisco International airport, reports U.S. Immigration and Customs Enforcement.

Han became a target of the federal probe in 2006, after US Customs and Border Protection officers intercepted a parcel containing counterfeit versions of erectile dysfunction medication. Subsequent investigation traced the shipment to Robin Han.

Just announced! Dr. Margaret Hamburg, FDA Commissioner will be the keynote speaker at the 2012 Interchange, September 28th in Washington DC!

We’ve just received official confirmation that Margaret Hamburg, Commissioner of the United States Food and Drug Administration, will give the keynote speech at the  2012 Partnership for Safe Medicines Interchange. We’re very honored to have Commissioner Hamburg speak at the Interchange, and look forward to hearing her offer her expertise on the subject of counterfeit drug crime.

Dr. Hamburg is the 21st commissioner of the Food and Drug Administration. She was confirmed in her post on May 18, 2009. She is only the second woman to be nominated for this position, having served previously as an Assistant Secretary at the US Department of Health and Human Services, and also as Commissioner of the New York City Department of Health.

Fake online drug sellers, gray market distributors, and counterfeit medicines in the U.S.’s safe, secure drug supply chain will be subjects discussed at the 2012 Interchange in Washington DC September 28th. Please join us!

This will be the second time Commissioner Hamburg has spoken at a Partnership for Safe Medicines Interchange. She first joined us in 2010, where she addressed the problem of counterfeit drugs, “The issue of counterfeit drugs is one of both domestic and international concern. It is shocking to realize that, in some parts of the world, somewhere between 30 and 50 percent of drugs to treat serious diseases are actually counterfeit.”

Since her appearance at the 2010 Interchange, the FDA has had to contend with an increasingly globalized drug marketplace. Her continued efforts as commissioner have been to seek greater penalties for drug counterfeiters, and also give the FDA more authority to deal with counterfeit drugs when they discover them.

We hope you will join Commissioner Hamburg, Deputy Director Heddell of the MHRA, Associate Director Dinkins of the ICE Homeland Security Investigations, along with many other experts from medicine, policy, law enforcement, and patient advocacy at our 2012 Interchange in Washington DC. Discounted early registration ends August 15th, so register today!

Patient safety is the concern of every doctor, nurse, and pharmacist working in medicine today, reminded Founder of Partnership of Safe Medicines India, Bejon Misra. Counterfeit drugs impact patient safety, particularly in places where the drug supply chain is compromised.

In 2011, when asked what safe medicines meant to him, he responded simply, “Saving millions of lives.“

In the global fight to combat counterfeit drug crime, simple SMS technology is leading the charge for patient safety. 

A simple and low-cost solution to drug verification problems for patients, SMS text verification empowers consumers to protect themselves from counterfeit drugs by sending a numeric code from their drug packaging from their phone for free verification.  We’ll be discussing this and other technological innovations in the counterfeit drug fight at the 2012 Interchange on September 28, 2012.

The MHRA has announced that three men have been sentenced to 89 weeks imprisonment for laundering $400,000 generated by a fake online pharmacy selling counterfeit medicines.

The men were prosecuted as part of a wider investigation.  From 2004 to 2009 they were laundering profits from a criminal online pharmacy website based in Cyprus.  Says the MHRA, “The business was run by a UK criminal who set up a number of illegal online pharmacy businesses selling counterfeit and powerful prescription-only medicines from outside of the UK.”

The MHRA has been on a tear of prosecutions against illegal online pharmacies and counterfeit medicine and medical device sellers.  In early 2012, the MHRA let FDA agents know they suspected counterfeit cancer medications were being passed into the U.S.  They also prosecuted UK-based counterfeit drug distributor Peter Gillespie in 2011, who was working closely with Kevin Xu, convicted in the US for manufacturing and distributing counterfeit medications in 2010.

MHRA Director of Inspection, Enforcement and Standards, Gerald Heddell, will be speaking at the 2012 Interchange on September 28.  The Interchange, at the National Press Club, in Washington, DC, is a full day conference of policymakers, pharmaceutical manufacturers, patient advocates, law enforcement, healthcare professionals, and anti-counterfeiting companies discussing the safety, health, and legal issues of counterfeit medications. Learn about the most recent criminal cases involving the MHRA and others at the 2012 Interchange.

MHRA agents made test purchases of counterfeit medicines to establish a link to the criminal enterprise, and then financial investigators traced over $1.5 million in three years from the websites’ UK bank account to a bank account in Cyprus. 

The impact that online counterfeit drug sales have on patients’ health is real, remarked Nimo Ahmed, Acting Head of Enforcement at MHRA. 

“This case highlights the criminality of the people who continue to put profit before patient’s health. These illegal pharmacy websites selling medicines bought from illegitimate sources pose a real threat to people’s health because they simply don’t know what they are getting.”

However, not all internet pharmacies are specious.  Online pharmacies that have the Verified Internet Pharmacy Practice Seal (VIPPS) are safe sources for the convenience and cost savings of online shopping, without the risks of potential counterfeit medications.

On September 10th, 2012, the India Office of the Partnership for Safe Medicines is organizing a Patient Safety and Drug Detection Technology Workshop in New Delhi, India.  Working with the Government of India, the workshop builds upon a September 2011 APEC Drug Safety and Detection Technology seminar held in Beijing.   The workshop’s objectives are…

H.R. 3668, the Counterfeit Drug Penalty Enhancement Act, was approved by the House of Representatives on June 18, 2012.  Sponsored by Representatives Patrick Meehan (R-Pa.), Tom Marino (R-Pa.), and Linda T. Sánchez (D-Calif.), the House bill has stiffer penalties for drug counterfeiters than the Senate approved version. Reports Bloomberg BNA, the House version of the bill…

FDA Commissioner Dr. Margaret Hamburg seeks stronger penalties to fight counterfeit drug trafficking, saying, “We need legal authorities to give teeth to our action. We are increasingly concerned that this is becoming an attractive area for bad guys, including organized crime,” reported The Financial Times. Dr. Hamburg told the Financial Times that current penalties for…

World Health Organization (WHO) representative Michael O’Leary has announced that China now has five anti-malaria drugs that have met WHO standards for prequalification. China Daily reports that a study released in January 2012 by the Wellcome Trust cites Chinese manufacturers as a major source of counterfeit anti-malaria drugs in Asia and Africa.   Head researcher…

The Food and Drug Administration has sent warning letters to more than 50 U.S. doctors and medical clinics that may have purchased counterfeit cancer injectable medication. Originally the FDA sent 19 medical practices warnings in March. The FDA warns the physicians that purchasing from foreign or unlicensed medicine suppliers puts patients at risk of exposure to potentially fake, contaminated, ineffective and dangerous medication.

FDA official Dr. S. Leigh Verbois, Acting Deputy Director of the Division of Supply Chain Integrity asked physicians in 15 states to avoid using the fake medications in letters dated April 5, 2012.   

The doctors who received these letters reside in Alabama, Arizona, California, Florida, Illinois, Maryland, Michigan, Nevada, New Jersey, North Dakota, Oregon, South Carolina, Tennessee, Texas and Washington.  See map to find doctors warned in your state here.

“…your medical practice purchased multiple medications from a foreign distributor named Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc. (BDMI). Many of the products sold and distributed by this distributor have not been approved by the FDA,” said Dr. Verbois’ letters.   

“The Agency has learned that one of the products distributed by Richards Pharma is a counterfeit version of Roche’s Altuzan 400mg/16ml. Even if the version had not been counterfeit, Altuzan itself is not approved by FDA,” the letters continue.  

“Other drug products obtained from Richards Pharma, Richards Services, Warwick Healthcare Solutions, BDMI, or other foreign or unlicensed suppliers may be from unknown sources, may have unknown ingredients, may be counterfeit, or may not have been manufactured, transported or stored under proper conditions as required by U.S. law, regulations, and standards.  

“Purchasing prescription drug products, such as injectable cancer medications, from foreign or unlicensed suppliers puts patients at risk of exposure to drugs that may be fake, contaminated, improperly stored and transported, ineffective, and dangerous. In virtually all cases, purchasing unapproved prescription drugs from foreign sources violates the Federal Food, Drug, and Cosmetic Act and is illegal.”

LEARN MORE ABOUT COUNTERFEIT CANCER MEDICATIONS
IN THE US AT THE 2012 PARTNERSHIP FOR SAFE MEDICINES INTERCHANGE.

REGISTER TODAY.

The FDA letter goes on to point out that the medication counterfeited is not in short supply, and points back to an FDA Drug Integrity and Supply Chain Security memo released to physicians in January 2012.  The letter states that the FDA knows that some physicians are purchasing unapproved injectable cancer medications, and reminds them that importing medications from foreign sources is in violation of the Federal Food, Drug and Cosmetic Act (FDCA).  

Dr. Margaret Hamburg, Commissioner of the FDA, wrote in the FDA’s blog, “For patients with cancer, combating the disease is difficult enough. But to learn that the cancer drug you were taking to save or prolong your life might be nothing but a counterfeit is unthinkable.”

In honor of World Malaria Day, we are reprinting this blog post by PSM Board member Tom Kubic, President and CEO of the Pharmaceutical Security Institute originally posted on the Sproxil blog April 3, 2012.

Partnership for Safe Medicines Carl L. Alsberg, MD, Fellow, Timothy Mackey, UCSD PhD student and senior research associate, has been awarded one of four Interdisciplinary Scholar Awards at University of California San Diego’s university-wide competition.

Consumers also need to know that only prescription medications purchased from legitimate pharmacies can treat STD, and to avoid so-called over-the-counter cures as well as prescription medications purchased from questionable sources.